Reported trial results for Retinal Vein Occlusion and Diabetic Macular Oedema
Every Retinal Vein Occlusion and Diabetic Macular Oedema trial Voxsanity tracks that has reported results to a public registry, newest first. These trials have finished, so they are not recruiting. Not medical advice.
162 trials have reported results.
AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
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NCT04692688 · results posted 8 June 2026
According to the results reported on ClinicalTrials.gov, this trial (NCT04692688) enrolled 103 people with diabetic retinopathy — a complication of diabetes that affects the eyes. Participants were split into two groups: 51 people received a treatment called APX3330, and 52 received a placebo (a dummy pill with no active ingredient). The trial was measuring changes in the severity of their diabetic retinopathy using a standard rating scale called the DRSS (Diabetic Retinopathy Severity Score), which runs from 10 to 90, where a higher number means a worse result. A total of 91 people completed the study — 45 in the APX3330 group and 46 in the placebo group. The reported data shows that the main thing being measured was whether participants' DRSS score improved by at least 2 steps from their starting point. In the APX3330 group, 39 out of 51 participants showed this level of improvement, while in the placebo group, 41 out of 52 participants did. For one of the secondary measures — looking at changes across both eyes together at 24 weeks — the reported data shows a range of results depending on how large a change was being counted. For example, when looking for a worsening of 1 or more steps, 3 participants in the placebo group showed this compared to 0 in the APX3330 group. For improvements of 3 or more steps, 14 participants in the APX3330 group and 13 in the placebo group were reported to have met that threshold. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT05217680 · results posted 26 May 2026
According to the results reported on ClinicalTrials.gov, this trial compared two eye injection treatments — an investigational medicine called PRO-169 and an already-approved medicine called Lucentis® (ranibizumab) — in people with a retinal eye condition. A total of 509 people were enrolled (255 in the PRO-169 group and 254 in the Lucentis® group), though the number who completed the full 12-month trial was 186 and 189 respectively. The main thing the trial was measuring was how much participants' best corrected visual acuity (that is, the sharpest vision possible with glasses or lenses, tested using a standardised letter-reading eye chart called ETDRS) changed over 12 months. Several secondary measures were also tracked, including the thickness of the central part of the retina and the overall volume of retinal tissue, both measured using a scanning technology called OCT. The reported data shows that, for the primary measure of vision improvement, participants in the PRO-169 group gained an average of approximately 8.89 letters on the eye chart by 12 months, while those in the Lucentis® group gained an average of approximately 11.15 letters over the same period. For central macular (retinal) thickness, the reported data shows an average reduction of about 97.70 micrometres in the PRO-169 group and about 141.84 micrometres in the Lucentis® group at 12 months. Retinal volume showed an average reduction of approximately 1.32 mm³ for PRO-169 and 1.82 mm³ for Lucentis® by the end of the study. A secondary measure of how participants' vision changed at the 4-month point showed an average gain of 8.70 letters for PRO-169 and 9.98 letters for Lucentis®. The reported data also shows that, when looking at the percentage of participants categorised as having a "positive response to treatment" at 12 months, 76 people in the PRO-169 group and 80 people in the Lucentis® group fell into this category, though the data does not provide a full breakdown of all response categories at every time point in a way that allows complete comparison across the whole study period. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT05151731 · results posted 11 May 2026
According to the results reported on ClinicalTrials.gov, this trial (NCT05151731) enrolled 394 participants across four groups. Three groups received different doses or schedules of an investigational treatment called vamikibart (either 0.25 mg every 8 weeks, 1 mg every 8 weeks, or 1 mg every 4 weeks), while a fourth group received an existing treatment called ranibizumab (0.5 mg every 4 weeks) for comparison. The trial was measuring changes in vision sharpness over time, as well as tracking unwanted medical events (called adverse events) that occurred during the study. Participants were split into those who had never previously been treated for their condition and those who had received prior treatment. The reported data shows that vision sharpness was scored using a letter-reading test (where a higher score means better vision, and a positive change from the starting point means improvement). Across all enrolled participants, the average change in vision score at around weeks 32–36 was reported as +4.4 letters for vamikibart 0.25 mg every 8 weeks, +3.6 letters for vamikibart 1 mg every 8 weeks, +5.5 letters for vamikibart 1 mg every 4 weeks, and +11.4 letters for ranibizumab. At the later timepoint (around weeks 44–48), the reported figures across all participants were +5.2, +3.3, +3.8, and +11.7 letters respectively. Results varied somewhat between those who were treatment-naïve and those previously treated, with similar patterns observed across the subgroups. The reported data also shows that unwanted medical events of any kind (both eye-related and body-wide) were recorded throughout the study. The number of participants who experienced any such event in each group was not broken down in full detail in the structured data provided, though counts were reported across multiple categories. Completion rates also differed between groups, with 57 out of 95 completing in the vamikibart 0.25 mg group, 64 out of 101 in the vamikibart 1 mg every 8 weeks group, 64 out of 98 in the vamikibart 1 mg every 4 weeks group, and 84 out of 100 in the ranibizumab group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT05850520 · results posted 18 December 2025
According to the results reported on ClinicalTrials.gov, this trial enrolled 892 people in total across three groups, all receiving a medicine called aflibercept as eye injections for an eye condition affecting vision. The three groups differed in the dose and timing of their injections: one group (301 people) received a lower dose every 4 weeks ("2q4"), a second group (293 people) received a higher dose on an every-8-week schedule with up to 3 loading injections ("8q8/3"), and a third group (298 people) received the same higher dose on a similar schedule but with up to 5 loading injections ("8q8/5"). The main thing being measured was how much participants' vision changed over the course of the trial, using a standard eye-chart letter score where a higher score means better vision. The reported data shows that for the primary measurement — change in vision score from the start of the trial to week 36 — the average improvement was 17.5 letters in the 2q4 group, 17.4 letters in the 8q8/3 group, and 18.3 letters in the 8q8/5 group. At week 64, the reported average improvements were 17.3, 17.8, and 18.1 letters respectively. The reported data also shows the number of actual injections given: over the full study period to week 64, the 2q4 group received an average of 11.7 injections, compared to 8.5 in the 8q8/3 group and 9.5 in the 8q8/5 group. In terms of the number of participants who gained 15 or more letters (roughly three lines on an eye chart) from their starting score, the reported figures at week 36 were 158 (2q4), 153 (8q8/3), and 161 (8q8/5), and at week 64 were 154, 156, and 161 respectively. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT05151744 · results posted 16 October 2025
According to the results reported on ClinicalTrials.gov, this trial enrolled 187 people in total — 93 in the group receiving a combination of vamikibart and ranibizumab (Arm A), and 94 receiving ranibizumab alone (Arm B). Participants were split into two sub-groups: those who had never previously been treated for their eye condition (124 people) and those who had received prior treatment (63 people). The trial's main focus was measuring changes in vision — specifically "best corrected visual acuity" (BCVA), which is simply how well a person can see on a standard eye chart — over roughly a year of follow-up. By the end of the study, 64 people in Arm A and 81 in Arm B completed the trial. The reported data shows that vision scores were measured using a standard eye chart where higher scores and larger gains from the starting point indicate better reading ability. For participants who had never been treated before (the primary outcome group), Arm A showed an average gain of 12.8 letters on the eye chart from their starting score, while Arm B showed an average gain of 9.4 letters. The reported data also shows results for the previously-treated group: Arm A gained an average of 11.1 letters and Arm B gained 8.4 letters. Across all participants combined, the reported averages were 12.4 letters for Arm A and 9.1 letters for Arm B. At an earlier time point (around weeks 32–36), the reported gains were 11.8 versus 9.3 letters (treatment-naïve) and 8.3 versus 7.5 letters (previously treated). The reported data also recorded the number of participants who experienced adverse events (which means any unwanted medical occurrence during the trial, not necessarily caused by the treatment). In Arm A, 54 out of 93 participants experienced systemic (whole-body) adverse events, compared with 60 out of 94 in Arm B. For eye-related adverse events, the figures were 33 in Arm A and 28 in Arm B, and a further category showed 25 in Arm A and 27 in Arm B — though the specific breakdown of these latter two categories was not clearly labelled in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT05301751 · results posted 15 October 2025
According to the results reported on ClinicalTrials.gov, this trial enrolled 25 people in total, spread across four groups (called cohorts): 3 people in Cohort 1, 6 in Cohort 2, 8 in Cohort 3, and 8 in Cohort 4. Almost all participants completed the study — one person in Cohort 3 did not finish. The trial was measuring changes in two things related to eye health: how well participants could read letters on a standardised eye chart (known as "best corrected visual acuity"), and changes in the thickness of a specific layer at the back of the eye (called "central subfield thickness"), measured using a detailed eye-scanning device. The reported data shows that, on average, all four cohorts had some change in their ability to read letters on the eye chart from the start of the study to its end. Cohort 1 changed by 3.7 letters, Cohort 2 by 9.2 letters, Cohort 3 by 4.3 letters, and Cohort 4 by 7.7 letters. For the eye thickness measurement (measured in micrometres, a very small unit of length), the reported data shows Cohort 1 had an average change of +2.3 micrometres (a very slight increase), while Cohorts 2, 3, and 4 had average reductions of 263.2, 70.4, and 50.6 micrometres respectively. No additional context about what these numbers mean clinically was reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT05511038 · results posted 4 September 2025
According to the results reported on ClinicalTrials.gov, a total of 121 people took part in this trial — 105 in a group who had not previously received treatment for their eye condition (called "Naïve") and 16 who had already had some prior treatment ("Pre-Treated"). The trial was looking at a treatment for a retinal eye condition and measured two main things: any unwanted medical events (called adverse events) that occurred during treatment, and how participants' vision and eye health changed over 52 weeks (about one year). Each participant had one eye enrolled in the study. The reported data shows that, for the primary outcome — tracking unwanted medical events during treatment — 36.5% of the Naïve group and 60% of the Pre-Treated group experienced eye-related events, while 21.2% of the Naïve group and 33.3% of the Pre-Treated group experienced non-eye-related events. Across all participants combined, those figures were 40% and 23% respectively. For the secondary outcomes, the reported data shows that the average thickness of the central part of the retina (a layer at the back of the eye) decreased by around 203.5 micrometres in the Naïve group and 160.3 micrometres in the Pre-Treated group by week 52. Regarding vision measured by a standard letter-reading eye chart, 3% of eyes across all participants lost 5 or more letters of vision from their starting point, while the number of participants whose vision improved by at least 5, 10, or 15 letters was reported as 87, 74, and 50 participants respectively across the whole group. Additionally, 15 participants across both groups showed a meaningful improvement (2 or more steps) on a standardised scale used to grade the severity of their retinal condition. It is worth noting that the data as submitted does not break down all figures in full detail for every sub-measure, so some specific numbers for individual sub-groups were not separately reported for every threshold. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT05697809 · results posted 3 September 2025
According to the results reported on ClinicalTrials.gov, this trial (called OXEYE) enrolled a very small number of participants — 1 person in the mid-dose group and 2 people in the high-dose group of a treatment called OXU-001, which was delivered using a special device called Oxulumis into the space at the back of the eye. Three other groups (a second mid-dose group, a second high-dose group, and a comparison group receiving an existing treatment called Ozurdex®) had zero participants enrolled. All participants who started the trial completed it. The trial was primarily measuring any unwanted health events — relating to either the treatment or the device — that occurred after participants received the treatment. The reported data shows that, for unwanted health events (sometimes called adverse events), no such events were recorded in the mid-dose participant, while both participants in the high-dose group had at least one recorded event of some kind. No serious adverse events or device-related events were reported for either group. For the additional measurements, the reported data shows changes in how many letters participants could read on a standard eye chart (a way of measuring vision): the mid-dose participant's reading improved by 9 letters at one time point and 11 letters at another, while the high-dose participants improved by an average of 6.5 letters and 10.5 letters at those same time points. The thickness of a central layer at the back of the eye — a measure sometimes used to track eye swelling — was also recorded; the mid-dose participant's measurement changed by −16 µm (micrometres, a very small unit of length) at one point and −10 µm at another, while the high-dose participants showed average changes of −165 µm and −81.5 µm at those time points. It is important to note that the numbers of people in this trial were extremely small — just 3 participants in total — which means the reported figures reflect only those individuals' experiences and cannot be used to draw broad conclusions. The reported data does not include results from the other planned groups, as no participants were enrolled in them. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT06011798 · results posted 5 August 2025
According to the results reported on ClinicalTrials.gov, this trial (NCT06011798) enrolled 52 people in total — 26 in a control group who received a standard anti-VEGF eye injection treatment, and 26 in a group who received a drug called foselutoclax. The trial was primarily measuring changes in vision, specifically how many letters participants could read on a standardised eye chart (called an ETDRS chart) after treatment, compared to when they started. Most participants finished the study — 23 in the control group and 24 in the foselutoclax group. The reported data shows that, for the main outcome — the average change in letters read on the eye chart at around weeks 20 and 24 — the control group gained an average of 5.1 letters from their starting point, while the foselutoclax group gained an average of 3.7 letters. By week 36, the reported numbers were closer together: 4.7 letters gained in the control group and 4.6 letters in the foselutoclax group. The trial also measured the thickness of a layer at the back of the eye (the central part of the retina); by week 36, the control group showed an average increase of 9.2 microns (a very small unit of measurement) from their starting point, while the foselutoclax group showed an average decrease of 1.9 microns. Regarding a "rescue" measure — where participants showing signs of worsening were given an additional treatment — the reported data shows 61.5% of the control group and 34% of the foselutoclax group required this at some point, though the full breakdown across the multiple rescue-related data points was not entirely clear from the reported figures. The reported data also includes counts of participants who experienced adverse events (unwanted health changes noted during the trial). In the control group, 15 out of 26 participants had at least one such event, compared with 22 out of 26 in the foselutoclax group. More detailed breakdowns were reported across several categories of events, but the individual category labels were not included in the submitted data, so a more specific description of those figures cannot be provided here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT06181227 · results posted 14 July 2025
According to the results reported on ClinicalTrials.gov, this trial looked at a treatment called AVD-104, given at two different dose levels — a low dose and a high dose. A total of 21 people took part: 10 in the low-dose group and 11 in the high-dose group. The trial was measuring whether any serious eye-related safety events occurred, as well as tracking two things in the eye over time: the thickness of a central layer at the back of the eye (called central subfield thickness, measured in microns — a very small unit of length), and vision sharpness (measured using a standard eye chart scoring system called ETDRS letters, where a higher number means better vision). The reported data shows that for the main thing being measured — serious adverse events detected by eye examination — zero participants in either the low-dose or the high-dose group had any recorded serious adverse events. For the eye thickness measurements, the reported figures were 653.5 microns and 803.5 microns at different time points for the low-dose group, and 432.0 microns and 560.3 microns at different time points for the high-dose group. For vision scores, the low-dose group recorded values of 52 and 25.5 ETDRS letters at different time points, while the high-dose group recorded 67 and 68 ETDRS letters. It is worth noting that only 3 participants in the low-dose group and 2 in the high-dose group completed the trial, meaning the numbers reported are based on a small number of people. It is also worth noting that the data submitted does not include information about when each measurement was taken or what the participants' starting values were, so the reported figures cannot be placed fully in context here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT04418427 · results posted 10 July 2025
According to the results reported on ClinicalTrials.gov, this trial (NCT04418427) looked at a condition called diabetic macular oedema (DME) — a build-up of fluid in the central part of the retina that can affect vision in people with diabetes. A total of 36 people were enrolled across three groups: 13 received a higher dose of a gene therapy called ADVM-022, 13 received a lower dose of ADVM-022, and 10 received the comparison treatment, aflibercept injections combined with a sham (dummy) procedure. The main thing the trial was measuring was how long it took for signs of DME to get noticeably worse in the treated eye, tracked over up to 96 weeks (roughly two years). The reported data shows that, for the primary measure — time until disease activity worsened — the higher-dose ADVM-022 group reached that point at an average of around 82 weeks, the lower-dose ADVM-022 group at around 96 weeks, and the aflibercept-plus-sham group at around 19 weeks. For retinal thickness (a scan-based measure of fluid in the retina), the reported average change from the start of the study to week 96 was a reduction of about 84 micrometres in the higher-dose group, and about 130 micrometres in both the lower-dose and aflibercept groups. For vision scores (measured in standardised letters read on a chart), the reported average change from the start of the study to week 96 was a loss of about 12 letters in the higher-dose group, a gain of about 10 letters in the lower-dose group, and a gain of about 17 letters in the aflibercept group. Regarding additional injections of aflibercept that participants needed during the study, the reported rate was approximately 1 injection per year in the higher-dose group, 0.4 per year in the lower-dose group, and 5.5 per year in the aflibercept group. The reported data also shows that eye-related unwanted events were recorded in all participants across the higher-dose and lower-dose ADVM-022 groups (12 and 13 participants respectively), and in all 9 participants in the aflibercept group; non-eye-related unwanted events were recorded in 9, 9, and 7 participants across the three groups respectively. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT04565756 · results posted 9 May 2025
According to the results reported on ClinicalTrials.gov, this trial (NCT04565756) enrolled 48 people in total across six groups. Participants had diabetic macular oedema (a build-up of fluid in the back of the eye related to diabetes). The trial tested an eye drop medicine called EXN407 at three different strengths (0.5 mg/mL, 1.0 mg/mL, and 1.5 mg/mL) compared with a placebo (inactive) eye drop. The main thing the trial set out to measure was how many participants experienced eye-related unwanted events — called "treatment-emergent adverse events" — after using the drops. The trial also tracked how the medicine moved through the body after being absorbed from the eye. The reported data shows that in the dose-escalation phase (the early stage testing rising strengths), 2 out of 3 participants in the lowest-dose EXN407 group had an eye-related unwanted event in their treated eye or the other eye, while 0 out of 3 in each of the two higher-dose EXN407 groups had such events. Among the pooled placebo group in this phase (4 participants), 0 reported such events. In the dose-expansion phase (the larger follow-on stage), 5 out of 23 EXN407 participants and 3 out of 12 placebo participants had eye-related unwanted events in the treated eye. For the body-absorption measurements, the data shows very small amounts of the medicine were detected in the bloodstream. The peak level in the blood was reached at around half an hour after dosing across the groups where it was measurable, and the peak concentration figures ranged from approximately 0.057 to 0.088 nanograms per millilitre (extremely small quantities). The Cohort 1 absorption data was reported as not available. The reported half-life (the time for the amount in the blood to reduce by half) was recorded as 0 hours across all groups where it was measured, suggesting the medicine left the bloodstream very quickly, though no further explanation of this figure was provided in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT05832996 · results posted 4 March 2025
According to the results reported on ClinicalTrials.gov, this trial looked at whether the temperature of artificial tear eye drops — either cooled or at room temperature — made a difference to the level of eye discomfort people felt after receiving an injection into the eye (known as an intravitreal injection). A total of 124 participants were enrolled across two groups: 56 people in the cooled artificial tear group and 68 people in the room temperature artificial tear group. Of those, 48 and 61 participants respectively completed the trial, meaning 8 and 7 people did not finish in each group. The reported data shows that the main thing being measured was each participant's self-reported pain or discomfort level after their eye injection, rated on a scale of 1 to 10 (where 1 means minimal discomfort and 10 means extreme discomfort). The cooled artificial tear group reported an average score of 2.21, while the room temperature artificial tear group reported an average score of 1.95. No other outcome measures were included in the submitted results data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT04707625 · results posted 24 February 2025
According to the results reported on ClinicalTrials.gov, this trial (NCT04707625) involved 17 participants who all received a treatment called aflibercept, which was given as an injection into the eye. The trial was looking at changes in swelling at the back of the eye (called macular oedema), the volume of that swelling, levels of a particular protein in the eye linked to fluid build-up (called VEGF), and vision. It is worth noting that while 17 participants started the trial, the data shows that none were recorded as having formally "completed" it — all 17 were listed under "not completed," though results were still reported. The reported data shows the following changes from the start of the trial to the end: the thickness of the central part of the retina decreased by an average of 504.4 cubic microns, and the overall volume of swelling decreased by an average of 5.2 cubic microns. The level of the VEGF protein measured in the fluid at the front of the eye decreased by an average of 203.5 pg/ml (picograms per millilitre, a very small unit of measurement). For vision, the reported data shows an average change of −0.33 LOGMAR units — LOGMAR is a scale used to measure eyesight, where a lower number generally means a reading closer to the better end of the scale. For two of the secondary outcomes — the number of injections received and changes in eye pressure — no numerical results were reported in the data submitted to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT03519581 · results posted 17 December 2024
According to the results reported on ClinicalTrials.gov, this trial (NCT03519581) compared two groups of people with a retinal condition: one group received micropulse laser treatment and the other received a sham (pretend) treatment. A total of 27 people were enrolled — 16 in the laser group and 11 in the sham group. However, only 4 people (2 in each group) completed the study, with 23 participants not finishing. The main thing the trial was measuring was how many participants experienced a meaningful drop in vision — specifically, vision falling to a level of 20/40 or worse based on a standard eye-reading chart test. The reported data shows that, for the primary measure, 5 eyes in the micropulse laser group and 3 eyes in the sham group reached that threshold of vision loss. For the secondary measures at 6 months, the laser group read an average of 79.4 letters on the eye chart compared to 83.9 letters in the sham group. When tested under dim lighting conditions, the laser group read an average of 30.7 letters versus 40.1 letters in the sham group. For contrast sensitivity (the ability to distinguish between shades of light and dark, scored from 0.0 to 2.0 where higher is better), the laser group scored 1.54 and the sham group scored 1.61. The reported data shows the thickness of the central part of the retina was nearly identical between groups — 357.8 microns in the laser group and 356.9 microns in the sham group. A test measuring the sensitivity of the central vision area (microperimetry) recorded an average of 22.5 units in the laser group and 24.4 units in the sham group. It is worth noting that the very low number of people who completed the trial — just 4 out of 27 — means the reported figures should be interpreted with considerable caution, and this limitation is reflected in the data as submitted. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT05269966 · results posted 10 December 2024
According to the results reported on ClinicalTrials.gov, this trial enrolled 105 people who received the eye injection treatment brolucizumab over 56 weeks (about one year). Of those, 95 people completed the study and 10 did not finish. The trial was primarily measuring what unwanted medical events (called adverse events) occurred that were thought to be related to the treatment. It also tracked changes in participants' vision using a standard eye chart reading test, where a higher score means better vision. The reported data shows that, for the primary focus of the study — tracking treatment-related unwanted medical events — various numbers of participants experienced different types of events, with figures ranging from 1 to 67 participants across the different categories reported. The breakdown of each specific event type was not fully labelled in the submitted data, so the full detail of what each number refers to cannot be described here. For vision, the reported data shows that on average, participants could read approximately 10.7 more letters on the eye chart at week 16 compared to when they started, rising to an average of 15.3 more letters at week 56. In terms of how many people gained vision, the reported numbers show that at week 56, around 78% of participants gained 5 or more letters, 62% gained 10 or more letters, and 46% gained 15 or more letters. Small numbers of participants — 2 to 3 people depending on the threshold — were reported to have lost letters at various time points. On average, participants received approximately 6.2 injections over the 56-week period. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT05512962 · results posted 20 November 2024
According to the results reported on ClinicalTrials.gov, this trial (NCT05512962) enrolled 25 people in total — 13 in a lower-dose group (2.4 mg) and 12 in a higher-dose group (4.0 mg). The trial was testing two different doses of a steroid medicine called triamcinolone acetonide, delivered into the back of the eye using a small device called the Oxulumis® microcatheter. The main things being measured were how often participants experienced unwanted events (side effects) related to the treatment or the device. The trial also tracked eye pressure, the thickness of a part of the retina called the macula, and how well participants could read letters on a vision chart over 24 weeks. The reported data shows that, for unwanted events related to the eye, 10 out of 13 participants in the lower-dose group and 8 out of 12 in the higher-dose group experienced at least one such event. Events affecting the rest of the body were recorded in 3 participants in the lower-dose group and 5 in the higher-dose group. No serious unwanted events and no events linked to the device itself were reported in either group. For the additional measurements, the reported data shows that the thickness of the central part of the retina (a marker of fluid/swelling) decreased on average by around 63–112 micrometres in the lower-dose group and 128–172 micrometres in the higher-dose group across the follow-up visits. Vision scores (measured using a letter-reading chart) increased on average by around 1–5 letters in the lower-dose group and 9–11 letters in the higher-dose group at various time points. Eye pressure changes were small in both groups, ranging from about −0.2 to +2.0 mmHg on average across visits. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT04292912 · results posted 8 November 2024
According to the results reported on ClinicalTrials.gov, this trial (NCT04292912) involved a single group of 16 participants who all received the investigational treatment GSK2798745. Nine participants completed the study, while seven did not finish. The trial was measuring a range of safety-related indicators over 28 days, including eye health, vision, body weight, body temperature, blood pressure, and pulse rate. The reported data shows the following numbers for changes between the start of the study and Day 28: vision (measured using a standard letter-reading chart, where higher scores mean better vision) changed by an average of +1.6 letters; body weight changed by an average of −0.34 kilograms; body temperature changed by an average of +0.04 degrees Celsius; systolic blood pressure (the top number in a blood pressure reading) changed by an average of +5.67 mmHg, and diastolic blood pressure (the bottom number) by +1.44 mmHg; and pulse rate changed by an average of −1.33 beats per minute. For the eye examinations — which looked at things like pupil movement, lens and cornea health, eye pressure, and detailed imaging of the eye — the reported data shows that out of several specific checks performed, one finding of potential clinical importance was noted on three separate examination types, while the remaining checks recorded zero such findings. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT04264819 · results posted 7 November 2024
According to the results reported on ClinicalTrials.gov, this trial (NCT04264819) enrolled 295 people with a condition called neovascular age-related macular degeneration (nAMD) — a form of age-related macular degeneration where abnormal blood vessels grow in the eye and can affect vision. All participants received the study drug, brolucizumab (also called RTH258). The trial tracked whether signs of active disease could still be detected in participants' eyes at certain points in time, and also measured changes in the thickness of the retina (the light-sensitive layer at the back of the eye) using a scanning technique called OCT. The reported data shows that at week 16, 89 out of 289 participants in the main analysis group showed no signs of active disease in the study eye, as judged by their treating doctor. By week 48, that number was reported as 102 participants with no detected disease activity. When it came to retinal thickness, the reported data shows average reductions in the thickness of the central part of the retina at various time points, ranging from approximately 49 to 88 micrometres (a micrometre is one-thousandth of a millimetre) thinner compared to the start of the study. The reported data also shows that at week 48, 122 participants were recorded as having a "dry retina" — meaning no detectable fluid build-up in or under the retina — compared to just 4 participants at the start of the study. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT04432831 · results posted 30 October 2024
According to the results reported on ClinicalTrials.gov, this trial (NCT04432831) enrolled 1,474 people across three groups, all of whom had previously been receiving treatment for a retinal eye condition. One group (493 people) had previously been on faricimab given every 8 weeks, another (506 people) had previously been on faricimab on a flexible "treat-and-extend" schedule, and a third (475 people) had previously been on a different medicine called aflibercept every 8 weeks. All three groups then continued or switched to faricimab on a flexible dosing schedule. The trial's primary focus was on recording and describing any unwanted medical events — called adverse events — that participants experienced during the study, both in the treated eye and in the rest of the body. The reported data shows that, looking at the treated eye, adverse events of any severity were recorded in 219 participants from the first group, 188 from the second, and 197 from the third. For the other (untreated) eye, adverse events were recorded in 186, 185, and 179 participants respectively across the three groups. When it came to unwanted events affecting the rest of the body (non-eye related), the reported data shows these occurred in 317 participants in the first group, 295 in the second, and 297 in the third. Within each of those totals, the events were further broken down by severity (mild, moderate, or severe), though the full breakdown across all severity categories is complex — the key figures above reflect the overall counts of participants who experienced at least one such event. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT04058067 · results posted 19 September 2024
According to the results reported on ClinicalTrials.gov, this trial (NCT04058067) enrolled 263 people — 132 in the brolucizumab 6 mg group and 131 in the aflibercept 2 mg group. Of those, 120 in each group completed the study. The trial was measuring changes in best-corrected visual acuity (BCVA) — that is, the sharpest vision a person can achieve with glasses or lenses — in the study eye over 52 weeks (roughly one year). Vision was scored on a standardised chart (called an ETDRS chart), where scores range from 0 to 100 and a higher score means better visual function. The reported data shows that both groups had higher vision scores at the end of the study compared to where they started. For the primary measure at week 52, the brolucizumab group's score had risen by an average of 10.6 points from their starting score, while the aflibercept group's score had risen by an average of 11.9 points. For the second primary measure — which looked at the average change across the final stretch of the study (weeks 40 to 52) — the brolucizumab group showed an average increase of 10.1 points and the aflibercept group showed an average increase of 12.0 points. The reported secondary results, which tracked vision changes at multiple time points throughout the year, showed similar patterns, with both groups recording gradually increasing scores over time across all measured periods. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT04611152 · results posted 22 August 2024
According to the results reported on ClinicalTrials.gov, this trial (NCT04611152) enrolled 460 people in total — 230 in each group. One group received an investigational treatment called KSI-301, and the other received aflibercept, an existing eye injection used for diabetic macular oedema (a condition where fluid builds up at the back of the eye, affecting vision). The trial's main goal was to measure any change in vision — specifically, how many letters participants could read on a standardised eye chart — from the start of the trial to around weeks 60 and 64. By the end of the study, 204 people in the KSI-301 group and 211 in the aflibercept group had completed the trial. The reported data shows that, on average, participants in the KSI-301 group gained 5.6 letters on the eye chart, while those in the aflibercept group gained 9.5 letters. For a secondary measure looking at worsening of the underlying diabetic eye disease (rated on a severity scale), 6% of KSI-301 participants and 3% of aflibercept participants showed a meaningful worsening at week 52 across two combined studies; in one study alone, no worsening of this kind was recorded in either group. The reported data also shows that, on average, KSI-301 participants received approximately 5.9 injections over the course of the study, compared with 9.2 injections in the aflibercept group. A separate measure of fluid in the retina (retinal thickness) showed an average reduction of around 140 microns in the KSI-301 group and around 159 microns in the aflibercept group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT04603937 · results posted 22 August 2024
According to the results reported on ClinicalTrials.gov, this trial (NCT04603937) enrolled 457 people in total — 229 received a treatment called KSI-301 and 228 received a comparator treatment called aflibercept. Both treatments are given as injections into the eye and were being studied in people with a condition affecting the retina (the light-sensitive layer at the back of the eye). The trial ran for over a year, and the main thing being measured was whether participants' vision changed — specifically, their best-corrected visual acuity (that is, the sharpest vision possible, even with glasses or contact lenses), scored using a standardised letter chart where a higher score means better vision. The reported data shows that, on average, participants in the KSI-301 group gained 6.7 letters on the vision chart from their starting point to around weeks 60–64, while those in the aflibercept group gained 11.5 letters over the same period. For a secondary measure looking at how the disease was progressing in the retina, 6% of participants in the KSI-301 group showed a meaningful worsening on a disease severity scale compared with 3% in the aflibercept group. The reported data also shows that KSI-301 participants received an average of 5.8 injections over the study period, compared with 9.2 injections for those on aflibercept. A scan measuring fluid and retinal thickness (in microns) showed an average reduction of 154.7 microns in the KSI-301 group and 194.2 microns in the aflibercept group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT04805541 · results posted 15 July 2024
According to the results reported on ClinicalTrials.gov, this trial enrolled 900 people in total, with 865 completing the study and 35 not completing it. The trial was testing an AI-based eye screening tool called EyeCheckup, which analyses photos of the back of the eye to detect signs of diabetic retinopathy (a diabetes-related eye condition). The tool was tested using three different camera brands — Optomed, Canon, and Topcon — to see how accurately it could identify two levels of concern: signs beyond mild diabetic retinopathy, and vision-threatening diabetic retinopathy. The reported data shows two key accuracy measures for each camera. The first, called "sensitivity" (meaning how often the tool correctly flagged people who did have the condition), ranged from about 90% to 96% depending on the camera and the level of disease being looked for. The second measure, called "specificity" (meaning how often the tool correctly gave the all-clear to people who did not have the condition), ranged from about 96% to 99% across the different cameras and disease levels. In general, the Canon and Topcon cameras returned slightly higher sensitivity figures than the Optomed camera for the milder disease category, while specificity figures were broadly similar across all three. The reported data also shows two secondary measures. Image quality was sufficient for the AI tool to produce a result in 96.6% of Optomed participants and 100% of both Canon and Topcon participants. For people whose eyes were photographed without dilation drops (a more convenient approach), the images were good enough for the tool to work in roughly 62% of Optomed cases, 69% of Canon cases, and 78% of Topcon cases. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT04592419 · results posted 6 June 2024
According to the results reported on ClinicalTrials.gov, this trial (NCT04592419) enrolled 284 participants in each of two groups — one group received a medicine called KSI-301, and the other received a medicine called aflibercept. Both medicines were being tested as treatments for retinal vein occlusion (RVO), a condition where a vein in the back of the eye becomes blocked. The trial measured changes in participants' best-corrected visual acuity — that is, the sharpest vision a person can achieve, even with glasses or contact lenses — using a standardised letter-reading chart (ETDRS), where a higher number of letters gained means better vision compared to the start. The reported data shows that, for the primary outcome at 24 weeks, participants with a specific type of RVO (branch retinal vein occlusion, or BRVO) gained an average of 14.2 letters in the KSI-301 group and 15.6 letters in the aflibercept group. When looking at all RVO participants together, the reported average gains were 13.0 letters for KSI-301 and 15.5 letters for aflibercept. For a secondary outcome tracking all RVO participants out to 48 weeks, the reported average letter gains at the final measured time point were 12.4 letters (KSI-301) and 15.3 letters (aflibercept). The reported data also shows that, at 48 weeks, 200 participants in the KSI-301 group and 209 in the aflibercept group had vision of 20/40 or better — a level generally considered sufficient for everyday tasks like driving. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT04857996 · results posted 16 May 2024
According to the results reported on ClinicalTrials.gov, this trial (NCT04857996) involved 65 people in total — 33 in a "sham control" group (who received a dummy procedure) and 32 who received a single injection of UBX1325, a drug being studied for eye disease. The trial was measuring how the body and eyes responded to the injection, and also tracking changes in vision over time. Of those who started, 26 people in the sham group and 24 in the UBX1325 group completed the study. The reported data shows that for whole-body (systemic) side effects, 4 participants in the sham group and 5 in the UBX1325 group experienced what are called treatment-emergent adverse events — meaning any health event that appeared or worsened after treatment began. For eye-related adverse events, 28 participants in the sham group and 23 in the UBX1325 group were reported to have experienced at least one such event; the trial notes these were largely related to disease progression or to the injection process itself. For vision changes, the reported data shows that participants were tested using a standard eye chart, with scores measured in "letters" read correctly. The UBX1325 group showed reported average improvements of between approximately 4.7 and 6.7 letters across different time points, while the sham group showed changes ranging from around -1.4 to +1.5 letters across the same periods. The specific time points for each measurement were not detailed in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT04697758 · results posted 22 March 2024
According to the results reported on ClinicalTrials.gov, this trial (NCT04697758) enrolled a small number of participants across three planned dose groups — a low dose group, a mid dose group, and a high dose group. Three people started and completed the low dose group, three people started and completed the mid dose group, and no participants were enrolled in the high dose group. The trial was measuring safety by looking at how many participants experienced unwanted health events (called adverse events), both in the eye being treated and in the body more generally. The reported data shows the following numbers for adverse events: in the low dose group, 2 out of 3 participants experienced one type of adverse event and 1 out of 3 experienced another type. In the mid dose group, 1 out of 3 participants experienced the first type of adverse event and 0 out of 3 experienced the second type. The data submitted does not include labels clearly distinguishing which figures relate to eye-related events versus body-wide events, so a more detailed breakdown cannot be provided here. No secondary outcome measure data was reported in the submitted results. It is worth noting that this was a very small trial — only six people in total completed the study — which means the numbers on their own are limited in what they can tell us. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT05182580 · results posted 6 February 2024
According to the results reported on ClinicalTrials.gov, this trial (NCT05182580) involved 993 participants in total — 494 in the intervention group (where an autonomous artificial intelligence system was used to assess patients with diabetes) and 499 in the control group (who received usual care). All participants completed the study with no drop-outs recorded. The trial was measuring how many patient care appointments could be completed per hour of a retina specialist's clinic time, comparing the two approaches. The reported data shows that in the intervention group, the AI system completed 1.59 care encounters per specialist clinic hour for patients with diabetes, compared to 1.14 in the control group. When looking at all patients (both with and without diabetes), the intervention group recorded 4.05 encounters per specialist hour, versus 3.36 in the control group. A secondary measure adjusted these figures for how complex each patient's eye condition was; the intervention group scored 3.15 on this adjusted measure compared to 1.19 in the control group. Regarding patient satisfaction with the autonomous AI process, 493 out of 494 participants in the intervention group reported being either "very satisfied" or "satisfied"; the reported data shows 499 out of 499 for the control group, though it is worth noting the control group did not interact with the AI system, so this figure may reflect satisfaction with the broader care experience rather than the AI specifically — the study report does not clarify this further. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT04740905 · results posted 18 January 2024
According to the results reported on ClinicalTrials.gov, this trial (NCT04740905) enrolled 553 people in total — 276 in one group (Arm A) and 277 in the other (Arm B). The trial was testing two eye injection treatments, faricimab and aflibercept, in people with a condition affecting their vision. The study ran in two parts: the first 24 weeks (Part 1) compared the two treatments given every four weeks, and a second phase ran through to week 72. The main thing the trial was measuring was how much participants' vision changed from the start of the trial to week 24, using a standard eye chart test (where a higher score means better vision). The reported data shows that, at week 24, participants in the faricimab group gained an average of 16.9 letters on the eye chart from their starting score, while those in the aflibercept group gained an average of 17.5 letters. For context on how many people saw larger gains: around 56% of people in the faricimab group and around 60% in the aflibercept group gained 15 or more letters by week 24. When looking at a smaller gain of 10 or more letters, the reported figures were approximately 78% for the faricimab group and 77% for the aflibercept group at week 24. For a gain of 5 or more letters, the reported figures were approximately 91% and 90% respectively. The reported data also shows that vision scores improved across both groups at every check-in point throughout the 24 weeks, with gains building gradually from the earliest visits. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
Read the full trial page · View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT04740931 · results posted 18 January 2024
According to the results reported on ClinicalTrials.gov, this trial (NCT04740931) enrolled 729 participants in total — 366 in Arm A (receiving faricimab every four weeks) and 363 in Arm B (receiving aflibercept every four weeks) during the first part of the study (up to 24 weeks). In the second part of the study (weeks 24 to 72), both groups switched to or continued faricimab on a personalised dosing schedule. The trial was primarily measuring changes in vision sharpness — specifically, how many letters participants could read on a standardised eye chart — compared to where they started at the beginning of the study. The reported data shows that by week 24 (the primary measurement point), participants in Arm A gained an average of 16.9 letters on the eye chart from their starting score, while participants in Arm B gained an average of 17.3 letters. On a secondary measure looking at the proportion of participants who gained 15 or more letters by week 24 — roughly considered a meaningful improvement in vision sharpness — the reported figures were 56.6% in Arm A and 58.1% in Arm B. The reported data also shows that around 72–73% of participants in Arm A and 73–75% in Arm B gained 10 or more letters by week 24, and approximately 85–87% in each group gained 5 or more letters at that same point. These numbers were tracked at several check-in points throughout the 24-week period, and the reported data shows the gains in letter scores generally increased over the first few weeks and then remained relatively steady through to week 24 in both groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
Read the full trial page · View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT03481660 · results posted 5 January 2024
According to the results reported on ClinicalTrials.gov, this trial enrolled 179 people in the brolucizumab 6 mg group and 181 people in the aflibercept 2 mg group — a total of 360 participants. Of these, 143 and 156 respectively completed the study. The trial was measuring vision changes in people with diabetic macular oedema (a condition where fluid builds up at the back of the eye due to diabetes), comparing two different eye injection treatments over roughly two years. Vision was measured using a standard letter-reading chart, where a higher score means better vision and a positive change from the starting point is considered a favourable result. The reported data shows that, for the main outcome measured at week 52, the brolucizumab group gained an average of 10.6 letters on the vision chart from their starting point, while the aflibercept group gained an average of 9.4 letters. For a secondary outcome looking at the average vision change between weeks 40 and 52, the brolucizumab group showed an average gain of 10.3 letters and the aflibercept group an average gain of 9.4 letters. Several secondary outcomes looked only at the brolucizumab group and tracked how many participants were able to stay on a less frequent injection schedule (every 12 or 16 weeks, rather than every 8 weeks). The reported data shows that approximately 50.3% of brolucizumab participants maintained the every-12-week schedule up to week 52, and among those who qualified for that schedule at week 36, about 95.1% maintained it to week 52 and about 69.6% maintained it (on either a 12- or 16-week schedule) through to week 100. Of those who moved to the every-16-week schedule, approximately 87.9% maintained that schedule through to week 100. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT04597918 · results posted 1 December 2023
According to the results reported on ClinicalTrials.gov, this trial enrolled 99 people, all of whom received a medicine called faricimab. All participants had a form of diabetic eye disease. By the end of the study, 89 people had completed it, while 10 did not finish. The trial was primarily measuring whether participants' diabetic eye disease showed a meaningful improvement — specifically, a two-or-more step improvement on a standard eye disease grading scale (called the ETDRS Diabetic Retinopathy Severity Scale) — after 24 weeks of treatment. Several secondary measurements were also tracked, including changes in vision sharpness, changes in the thickness of a central part of the retina, and the presence or absence of fluid in different layers of the eye. The reported data shows that 50% of participants met the primary goal of a two-or-more step improvement on the eye disease grading scale at week 24. For the secondary measurements, the reported data shows an average improvement of 9.2 letters on a standard vision chart (where a higher score means better vision). The average thickness of the central retina was reported to have decreased by 200.2 microns (a micron is a very tiny unit of measurement). The midpoint time at which participants first showed no sign of diabetic swelling in the central retina was reported as 8 weeks. At week 24, 26.1% of participants were reported to have no fluid within the retinal layers, while 98.9% were reported to have no fluid beneath the retina. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT04429503 · results posted 21 November 2023
According to the results reported on ClinicalTrials.gov, this trial (NCT04429503) involved people with diabetic eye disease affecting their vision. A total of 660 participants were enrolled across three treatment groups during the main study phase: 167 received a standard dose of a medicine called aflibercept every 8 weeks, 329 received a higher dose every 12 weeks, and 164 received the same higher dose every 16 weeks. A smaller group of 265 participants then continued into an optional extension phase running from around the two-year mark to three years. The trial was primarily measuring changes in vision sharpness (how many letters participants could read on a standard eye chart) at 48 weeks, and also looked at a range of other eye-related measurements. The reported data shows that, at 48 weeks, all three groups had improved their average letter score on the eye chart from where they started. The standard-dose every-8-weeks group gained an average of about 8.7 letters, the higher-dose every-12-weeks group gained about 8.1 letters, and the higher-dose every-16-weeks group gained about 7.2 letters. For the secondary measurements at 48 weeks: roughly 23%, 19%, and 17% of participants in each group respectively gained 15 or more letters from their starting score; about 63%, 65%, and 63% had a vision score of 69 letters or above; and approximately 55%, 59%, and 44% showed no fluid detected at the centre of the retina (the light-sensitive tissue at the back of the eye). The average reduction in retinal thickness (a measure of swelling) was around 165 microns, 177 microns, and 149 microns across the three groups. Regarding a measure of the overall severity of diabetic eye disease, roughly 27%, 29%, and 20% of participants showed a meaningful improvement of at least two steps on the severity scale used. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT03927690 · results posted 12 October 2023
According to the results reported on ClinicalTrials.gov, this trial (NCT03927690) enrolled 91 participants across three groups: 28 received a treatment called LKA651 alone, 30 received LKA651 combined with Lucentis (a medicine already used for certain eye conditions), and 33 received Lucentis alone. By the end of the study, 21, 27, and 31 participants in each group respectively had completed the trial. The trial was primarily measuring a range of things related to safety signals and eye health, including unwanted medical events (called adverse events), eye pressure, vision scores, and the thickness of a specific layer at the back of the eye (the macula). The reported data shows that, when it came to any unwanted medical events overall, 20 out of 28 participants in the LKA651 group, 16 out of 30 in the combination group, and 19 out of 33 in the Lucentis-only group experienced at least one such event. For events specifically affecting the study eye, the numbers were 11, 7, and 9 participants respectively. Eye pressure (measured in mmHg, a standard unit) was broadly similar across all three groups, sitting around 15 mmHg at the start and remaining in a similar range over time. Vision was measured on a scale of 0 to 100 (higher meaning better), and the reported data shows scores starting around 61–64 across groups and moving to approximately 65–69 by later time points. The thickness of the lower portion of the macula was reported as around 503 micrometres in the LKA651 group, 401 in the combination group, and 390 in the Lucentis-only group, though the data did not include additional time points for this measure. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT02914613 · results posted 11 May 2023
According to the results reported on ClinicalTrials.gov, this trial enrolled 44 people in total — 22 in a lower-dose group receiving SF0166 eye drops at 2.5% twice daily, and 22 in a higher-dose group receiving SF0166 at 5.0% twice daily. The study ran for 8 weeks and used a specialised eye examination (called a slit lamp) to track changes in the eye over time. Of the 44 who started, 40 completed the trial — 2 people dropped out from each group. The reported data shows that across several eye measurements taken at different points from the start through to week 8, the numbers of participants showing signs such as pooled blood in the front of the eye (hyphema), redness of the white part of the eye (conjunctival injection), skin redness (erythema), and swelling (edema) were very low or zero at most time points in both groups. For the measure tracking red blood cells in the front part of the eye, the reported data shows that by week 8, 20 participants in the lower-dose group and 19 in the higher-dose group had no cells observed. For a separate measure called "flare" — a cloudiness in the fluid at the front of the eye — the reported numbers showed zero participants with flare recorded at any time point in either group. One participant in the higher-dose group was recorded with redness and skin redness at one time point, and one participant in each group was recorded with swelling at various time points. The data does not include further detail on the specific breakdown of all individual time points for each measure. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT03610646 · results posted 7 March 2023
According to the results reported on ClinicalTrials.gov, this trial (NCT03610646) enrolled 355 people in total — 179 in the MYL-1701P group and 176 in the Eylea group — though one person in the MYL-1701P group did not receive treatment. The trial was comparing MYL-1701P, a proposed biosimilar (a medicine designed to be very similar to an already-approved medicine), against Eylea (aflibercept), an existing eye injection used for certain conditions affecting vision. The main thing being measured was how much participants' vision changed by week 8, using a standardised eye chart where a higher score means better vision. The reported data shows that by week 8, participants in the MYL-1701P group read an average of 6.60 more letters on the eye chart compared to the start of the trial, while those in the Eylea group read an average of 6.56 more letters. Over the full 52-week study period, the reported average improvement across all time points was 10.76 letters for the MYL-1701P group and 10.52 letters for the Eylea group. The reported data also shows that the average thickness at the back of the eye (central retinal thickness) decreased by around 170 micrometres in the MYL-1701P group and around 168 micrometres in the Eylea group. Fifty-seven participants in the MYL-1701P group and 51 in the Eylea group gained 15 or more letters on the eye chart from the start of the study. Participants received an average of 8.4 doses (MYL-1701P) and 8.7 doses (Eylea) over the year. Regarding side effects, 138 participants in each group were reported to have experienced at least one treatment-emergent adverse event (an unwanted medical event that occurred after starting treatment); no further breakdown of those events was included in the submitted results data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT03481634 · results posted 28 October 2022
According to the results reported on ClinicalTrials.gov, this trial enrolled 566 people across three treatment groups: 190 received brolucizumab 3 mg, 189 received brolucizumab 6 mg, and 187 received aflibercept 2 mg. All participants had a specific range of reduced vision in one eye at the start of the trial. The trial was measuring changes in vision over 52 weeks (about one year), using a standard eye-chart test called the ETDRS chart, where a higher score means better vision. Roughly 153–157 people in each group completed the full study period. The reported data shows that the primary measure — the change in vision score from the start of the trial to week 52 — was 7.3 letters for the brolucizumab 3 mg group, 9.2 letters for the brolucizumab 6 mg group, and 10.6 letters for the aflibercept group (meaning all three groups had higher vision scores at week 52 than at the start). For a secondary measure looking at average vision change between weeks 40 and 52, the reported figures were 7.0 letters, 9.0 letters, and 10.5 letters for the three groups respectively. Another secondary measure looked at how likely participants in the brolucizumab groups were to stay on a less-frequent injection schedule (every 12 weeks); the reported data shows that probability fell over time, reaching approximately 0.474 for the 3 mg group and 0.550 for the 6 mg group by the final timepoint measured. The reported data also shows vision score changes at later timepoints (around weeks 88–100): 6.7 letters for the brolucizumab 3 mg group, 8.6 letters for the brolucizumab 6 mg group, and 10.6 letters for the aflibercept group. Safety data was not included in the structured results submitted to ClinicalTrials.gov and therefore cannot be described here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT03097068 · results posted 24 October 2022
According to the results reported on ClinicalTrials.gov, this trial involved 10 participants, all of whom received a 0.3 mg dose of a medicine called Lucentis (ranibizumab). All 10 participants completed the study — none dropped out. The trial was measuring levels of a protein called VEGF (Vascular Endothelial Growth Factor) in fluid collected from the eye. VEGF is a substance the body produces that can affect blood vessels in the eye, and the trial aimed to track whether its levels changed over the course of treatment. The reported data shows that VEGF levels were measured in eye fluid samples taken at the start of the trial and again at 12 weeks. The result reported for the group was 73.46 pg/ml (picograms per millilitre — a very small unit used to measure tiny amounts of a substance in fluid). It is important to note that only one measurement figure was reported in the submitted data, and a separate baseline (starting point) figure was not included in the structured results as submitted to ClinicalTrials.gov, so a direct before-and-after comparison cannot be drawn from the numbers provided here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT04812977 · results posted 3 October 2022
According to the results reported on ClinicalTrials.gov, this trial (NCT04812977) involved 30 people in total, split evenly into two groups of 15 — a "Combination Group" and a "Standard Group". All 30 participants completed the trial with no drop-outs. The trial was measuring two things: changes in visual acuity (sharpness of vision) and changes in central foveal thickness (the thickness of a small, central part of the retina at the back of the eye that is important for detailed vision). The reported data shows that for visual acuity, results were recorded in "logMAR units" — a standard scale used to measure vision, where a lower number generally means sharper vision. The Combination Group returned a value of 0.32 logMAR units, while the Standard Group returned a value of 0.44 logMAR units. For central foveal thickness, measured in microns (very small units of length), the Combination Group recorded a value of 264.4 microns and the Standard Group recorded a value of 271.01 microns. It is important to note that these figures represent the changes measured during the study period, not a full picture of each participant's vision or eye health overall. The reported data does not include additional details such as how these numbers compare to participants' starting measurements, or what the researchers concluded from these figures — only the values above were submitted to ClinicalTrials.gov as part of the structured results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT03810313 · results posted 8 August 2022
According to the results reported on ClinicalTrials.gov, this trial (NCT03810313) enrolled 247 people in the brolucizumab 6 mg group and 246 people in the aflibercept 2 mg group — 493 participants in total. The trial compared these two eye injection treatments in people with a retinal eye condition, and the main thing it was measuring was change in vision sharpness (called "best-corrected visual acuity," or BCVA) over time. Vision was measured using a standard eye chart, scored from 0 to 100 letters, where a higher number means better vision. It is worth noting that only 66 participants in the brolucizumab group and 70 in the aflibercept group completed the study, while the majority did not complete it; the data does not explain why. The reported data shows that, at the main measurement point of 24 weeks, participants in the brolucizumab group read an average of 13.2 more letters than they did at the start of the trial, while those in the aflibercept group read an average of 16.0 more letters than at the start. The reported data also shows similar patterns at later time points: averaged across weeks 40–52, the increases were 13.4 letters (brolucizumab) and 15.4 letters (aflibercept); and averaged across weeks 64–76, the increases were 14.0 letters (brolucizumab) and 16.9 letters (aflibercept). Regarding the number of participants who gained vision, at one reported visit 181 people in the brolucizumab group and 189 in the aflibercept group gained at least 5 letters (roughly one line on the chart). Regarding those who lost vision, at the same visit 10 people in the brolucizumab group and 7 in the aflibercept group lost 5 or more letters compared to their starting point. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT03802630 · results posted 28 July 2022
According to the results reported on ClinicalTrials.gov, this trial (NCT03802630) enrolled 450 people in total — 226 in the brolucizumab 6 mg group and 224 in the aflibercept 2 mg group. The trial was measuring changes in vision over time in both groups. Vision was tested using a standard eye chart (called an ETDRS chart), where a higher score — measured in letters read correctly — means better visual functioning. The scores could range from 0 to 100 letters. Around 73–76 participants per group completed the study, while the majority did not complete it; reasons for non-completion were not detailed in the submitted data. The reported data shows that the primary measure — change in vision score from the start of the trial to week 24 — was an average gain of 13.1 letters in the brolucizumab group and 15.0 letters in the aflibercept group. For the secondary measures tracking vision changes at later time points, the reported average gains were 12.9 letters (brolucizumab) versus 16.9 letters (aflibercept) averaged over weeks 40–52, and 13.7 letters versus 17.9 letters averaged over weeks 64–76. When looking at the proportion of participants who gained at least 15 letters (roughly three lines on the chart) at any point during the study, the reported data shows 64 participants in the brolucizumab group and 79 in the aflibercept group achieved this. The number of participants who lost 15 or more letters was reported as zero in both groups at the week-24 visit. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT03397264 · results posted 22 June 2022
According to the results reported on ClinicalTrials.gov, this trial (NCT03397264) looked at a combination of two medicines — aflibercept and OPT-302 — in people with a retinal eye condition. The trial had two stages. The first stage (Phase 1b) enrolled 9 people across three small groups to test different doses of OPT-302 alongside aflibercept. The second stage (Phase 2a) enrolled 144 people, with 96 receiving the combination treatment and 48 receiving aflibercept plus a sham (inactive) injection for comparison. The trial was primarily measuring how many participants experienced side effects, and in Phase 2a, also how many people's vision improved by at least 5 letters on a standard eye chart by week 12. The reported data shows that in Phase 2a, 38 out of 96 participants in the combination group gained at least 5 letters of vision on the eye chart by week 12. Regarding side effects, the reported data shows numbers of participants who experienced treatment-related adverse events (unwanted health events recorded during the trial) across all groups, though the full breakdown across all categories was not completely reported in the structured data provided. For the secondary measures, the reported data shows that average vision (measured in letters on an eye chart) changed by approximately +5.9 letters in the Phase 2a combination group and +6.1 letters in the sham comparison group. The reported data also shows changes in the thickness of a layer at the back of the eye (measured in micrometres): an average reduction of 52.2 µm in the combination group and 34.9 µm in the sham group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT03866473 · results posted 10 June 2022
According to the results reported on ClinicalTrials.gov, this trial enrolled 135 people in total across two groups — 69 received a photobiomodulation (PBM) treatment (a type of light-based therapy applied to the eye) and 66 received a placebo (an inactive version of the same treatment). The trial was measuring changes in a condition called diabetic macular oedema — a swelling in the central part of the retina that can occur in people with diabetes. The main thing being tracked was the thickness of the central part of the retina, measured using a specialised eye scan called Optical Coherence Tomography (OCT), over a four-month period. A second phase then followed a portion of participants for a further four months. The reported data shows that over the first four months, the central retinal thickness changed by an average of 13 micrometres (a very small unit of measurement) in the PBM group, and 15 micrometres in the placebo group. For retinal volume (the overall size of the swelling), both groups showed a small increase — 0.12 mm³ in the PBM group and 0.10 mm³ in the placebo group. Vision, measured using a letter-reading chart score, changed by an average of −0.2 letters in the PBM group and −0.6 letters in the placebo group, meaning both groups showed very small declines. In the second four-month phase, central retinal thickness changed by −1 micrometre in the PBM group and −2 micrometres in the placebo group — very small changes in both cases. The reported data also shows that at four months, 61 eyes in the PBM group and 57 eyes in the placebo group still had swelling at the centre of the retina. Three eyes in the PBM group and one eye in the placebo group received an alternative treatment for the condition during the trial period. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT05343156 · results posted 2 June 2022
According to the results reported on ClinicalTrials.gov, this trial (NCT05343156) enrolled 144 participants in total — 99 people received a DexNP eye drop and 45 received a vehicle eye drop (a comparison drop without the active ingredient). Most participants completed the trial: 91 in the DexNP group and 42 in the vehicle group. The trial was measuring changes in vision, specifically using a standard eye-chart test called the ETDRS chart, which counts the number of letters a person can correctly read. The main question was how much participants' letter scores changed over 12 weeks. The reported data shows that, on average, participants in the DexNP eye drop group gained approximately 2.62 letters on the eye chart from the start to week 12, while participants in the vehicle eye drop group gained approximately 1.04 letters over the same period. These numbers represent average changes across each group. No other outcome measures were included in the submitted results data, so additional findings — if any were collected — were not reported in the data available here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT03917472 · results posted 21 April 2022
According to the results reported on ClinicalTrials.gov, this trial (NCT03917472) enrolled 517 people with diabetic macular oedema — a condition where fluid builds up in the central part of the retina, affecting vision. Participants were split into two groups: 346 received injections of brolucizumab 6 mg every four weeks, and 171 received injections of aflibercept 2 mg every four weeks. The main thing being measured was how much participants' best-corrected visual acuity (that is, how well they could see with the best possible glasses correction) changed over 52 weeks, using a standard letter-reading chart scored from 0 to 100, where a higher score means better vision. The reported data shows that, on average, the brolucizumab group's vision score improved by 12.2 letters from their starting point over 52 weeks, while the aflibercept group's score improved by 11.0 letters. For the secondary outcomes, the trial also measured changes in the thickness of the central part of the retina (a sign of fluid build-up). The reported data shows that by around week 52, retinal thickness had reduced by an average of 217.5 micrometres in the brolucizumab group and 178.8 micrometres in the aflibercept group. Regarding the number of participants whose retinas were completely free of fluid by week 52, the reported figures were 84 out of 346 in the brolucizumab group and 19 out of 171 in the aflibercept group. The number of participants whose retinal thickness fell below the threshold used to define diabetic macular oedema by week 52 was reported as 177 in the brolucizumab group and 52 in the aflibercept group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02510885 · results posted 19 April 2022
According to the results reported on ClinicalTrials.gov, this trial enrolled 39 participants and all 39 completed the study — no one dropped out. The trial was looking at a type of eye scan called SD-OCT Angiography (a non-invasive imaging technique that takes detailed pictures of blood vessels in the back of the eye). The main thing researchers were measuring was whether the images produced by this scan were clear enough to identify specific patterns in abnormal blood vessel growth in the eye. The reported data shows that for the primary outcome — whether the scan images were of good enough quality to identify those specific blood vessel patterns — all 39 out of 39 participants had images that met this standard. No secondary outcome measures appear to have been reported in the data submitted to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT03622580 · results posted 22 March 2022
According to the results reported on ClinicalTrials.gov, this trial (NCT03622580) enrolled 940 people in total across three groups: 315 received faricimab 6 mg on a fixed every-8-week schedule (Group A), 313 received faricimab 6 mg on a personalised treat-and-extend schedule (Group B), and 312 received aflibercept 2 mg on a fixed every-8-week schedule (Group C). The trial was measuring changes in vision in people with diabetic macular oedema — a condition where fluid builds up at the back of the eye due to diabetes. Vision was tested using a standard letter chart, and the trial also looked at whether the underlying diabetic eye disease showed signs of changing in severity. The reported data shows that the primary outcome — the average change in the number of letters read correctly on the vision chart between weeks 48, 52, and 56 — was approximately 10.7 letters gained for Group A, 11.6 letters for Group B, and 10.9 letters for Group C (in the overall study population). Similar figures were reported for participants who had not previously received eye injections. For one of the secondary outcomes, the reported data shows that around 46% of Group A, 42.5% of Group B, and 35.8% of Group C showed at least a two-step improvement in diabetic retinopathy severity at week 52 (overall population). When looking at participants who gained 15 or more letters on the vision chart averaged over the final three visits, the reported figures were approximately 29.2% for Group A, 35.5% for Group B, and 31.8% for Group C. The reported data also shows that across all three groups, roughly 91–94% of participants were recorded as gaining at least some vision (zero or more letters) by the end of the study. Vision changes over time followed a broadly similar pattern across all three groups throughout the trial. Results for participants who had not previously had eye injections were reported separately and showed comparable figures to the overall group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT03622593 · results posted 22 March 2022
According to the results reported on ClinicalTrials.gov, this trial (NCT03622593) enrolled 951 people across three groups: 317 received faricimab 6 mg every eight weeks (fixed schedule), 319 received faricimab 6 mg on a personalised, adjustable schedule, and 315 received aflibercept 2 mg every eight weeks (a comparison treatment). The trial was measuring changes in vision in people with diabetic macular oedema — a condition where fluid builds up at the back of the eye and can blur sight. The main thing being tracked was how many letters participants could read on a standard eye chart, measured at weeks 48, 52, and 56. The reported data shows that, on average, all three groups gained letters on the eye chart compared to where they started. For the primary measure (average letter gain across weeks 48–52–56), the fixed faricimab group gained approximately 11.8 letters, the adjustable faricimab group gained approximately 10.8 letters, and the aflibercept group gained approximately 10.3 letters. For one of the secondary measures — the proportion of people whose vision improved by 15 or more letters — the reported figures averaged across weeks 48, 52, and 56 were approximately 33.8% in the fixed faricimab group, 28.5% in the adjustable faricimab group, and 30.3% in the aflibercept group. The reported data also shows that around 44–47% of participants across all three groups showed a meaningful improvement in the severity grading of their diabetic retinopathy at week 52, depending on the group and population assessed. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02390245 · results posted 11 March 2022
According to the results reported on ClinicalTrials.gov, this trial involved 906 people in its first phase, where participants had their eyes scanned using a handheld camera and had their eye pressure measured using a non-contact device — all done remotely (via telemedicine). From those 906, a total of 551 people were then randomly placed into one of two groups for the later phases: 275 in an "enhanced intervention" group and 276 in a "usual care" group. The trial was looking at how well telemedicine could detect glaucoma and other eye conditions, and then whether extra support helped people follow through with recommended eye care appointments afterwards. The reported data shows that during the first telemedicine phase, camera images of participants' eyes were grouped into three categories, with 355, 384, and 167 participants falling into each category respectively. For eye pressure readings, the reported data shows 728 participants had readings within a normal range, 163 had results that were not reported in detail, and smaller numbers (10, 3, and 2 participants) had notably elevated pressure readings. When an eye specialist then examined participants in person to confirm what the telemedicine screening had found, the reported numbers across different diagnosis categories were 38, 159, 25, 23, 15, 84, and 207 participants — though the specific label for each category was not described in the submitted data in a way that allows plain identification of each group. For the follow-up phase, the reported data shows that in the enhanced intervention group, 128 participants attended their recommended follow-up eye appointments, compared with 67 in the usual care group. For a further follow-up visit, 97 in the enhanced intervention group and 39 in the usual care group attended. Smaller numbers — 32 versus 14, 27 versus 9, and 5 versus 1 — were reported across additional follow-up visit categories, though the full context for each of these figures was not described in complete detail in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT03093701 · results posted 23 December 2021
According to the results reported on ClinicalTrials.gov, this trial (NCT03093701) enrolled 31 participants across three active groups (10 in Group 1, 10 in Group 2, and 11 in Group 3). A fourth group had zero participants. The trial was measuring vision changes in participants' eyes — specifically, how many people gained a meaningful improvement in their ability to read letters on an eye chart (known as "best corrected visual acuity," or BCVA — essentially how well someone can see with the best possible glasses or lenses). Three participants from Group 2 did not complete the study, while all participants in Groups 1 and 3 finished. The reported data shows that the main (primary) outcome looked at how many participants gained 15 or more letters on the eye chart from where they started — considered a noticeable improvement in vision. According to the results reported on ClinicalTrials.gov, exactly 1 participant in each of the three groups met this measure — so 1 out of 10 in Group 1, 1 out of 10 in Group 2, and 1 out of 11 in Group 3. It is worth noting that participants who needed to use additional ("rescue") treatments within 6 months were counted as not having achieved this level of improvement. No secondary outcome measure data appears to have been reported in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT02634333 · results posted 24 November 2021
According to the results reported on ClinicalTrials.gov, this trial (NCT02634333) enrolled 200 people in the aflibercept (an eye injection) group and 199 people in a sham (fake procedure) group — 399 participants in total. The trial was looking at two main things in people with diabetic eye disease: whether a more serious form of the condition (called proliferative diabetic retinopathy, or PDR) or a swelling of the central part of the retina (called diabetic macular oedema, or DME) developed over time, and whether vision changed from the start of the study to the end. The reported data shows that, for the primary outcome measuring disease progression, 27 eyes in the aflibercept group and 75 eyes in the sham group met the criteria for developing PDR and/or DME (whichever came first). For the secondary measure of the same outcome tracked over a longer period, the reported numbers were 54 eyes in the aflibercept group and 97 eyes in the sham group. Regarding vision changes, the primary vision outcome showed an average change of −0.9 letters for the aflibercept group and −2.0 letters for the sham group (on a 0–100 scale where higher numbers mean better vision, and a 5-letter change is roughly one line on an eye chart). A secondary vision measure reported an average change of −2.7 letters for the aflibercept group and −2.4 letters for the sham group. Of the participants who started the trial, 160 in the aflibercept group and 167 in the sham group completed the study; the data does not explain in detail why the remaining participants did not finish. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT04085341 · results posted 15 July 2021
According to the results reported on ClinicalTrials.gov, this trial (NCT04085341) involved 21 people in total — 10 received a lower dose of GB-102 (1 mg) and 11 received a higher dose (2 mg). All 21 participants completed the study. The trial was looking at a treatment for an eye condition and was primarily measuring how often unwanted health events (called adverse events) occurred. It also tracked changes in participants' vision, changes in the thickness of a layer at the back of the eye (the central part of the retina), and how long it took before someone needed additional ("rescue") treatment. The reported data shows that, when it came to adverse events, 7 out of 10 people in the lower-dose group and 10 out of 11 in the higher-dose group experienced at least one such event during the study. For vision — measured using a standard letter-reading chart where a higher score means better vision — the reported data shows an average change of minus 10.4 letters in the lower-dose group and minus 16.7 letters in the higher-dose group from the start of the study. Regarding retinal thickness — measured in micrometres (a very small unit of length) — the lower-dose group showed an average increase of 131.0 micrometres, while the higher-dose group showed an average decrease of 37.4 micrometres. The reported data shows the average time before rescue treatment was needed was 90 days in the lower-dose group and 120 days in the higher-dose group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT03739593 · results posted 2 July 2021
According to the results reported on ClinicalTrials.gov, this trial (NCT03739593) involved a treatment called AR-1105 and was carried out in two stages: an initial phase and a randomisation phase (where participants were assigned to one of two versions of the treatment, CF1 or CF2). A total of 5 people took part in the initial phase, and 22 people were in each of the two randomisation groups — giving 49 participants across the study overall. Of those, 2 completed the initial phase, while 16 and 14 completed the two randomisation groups respectively. The reported data shows that the primary outcome the trial was measuring was safety and tolerability — specifically, how many participants experienced what are called "treatment-emergent adverse events" (TEAEs), meaning any unwanted health events that occurred during or after receiving the treatment. According to the results reported on ClinicalTrials.gov, all 5 participants in the initial phase and all 22 participants in each of the two randomisation groups were counted as having experienced at least one such event. The trial's results page notes that a more detailed breakdown of these events is available in a separate section of the ClinicalTrials.gov record, but only the total participant counts were included in the primary outcome data provided here. It is worth noting that no secondary outcome measure data appears to have been submitted as part of this results report, so those figures are not available to describe. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02963441 · results posted 28 May 2021
According to the results reported on ClinicalTrials.gov, this trial (NCT02963441) enrolled 900 people in total, with 819 completing the study and 81 not completing it. The trial was testing a device called IDx-DR, which is designed to automatically analyse eye images to detect signs of diabetic retinopathy (a diabetes-related eye condition). The study measured how well the device could correctly identify people who had the condition and correctly identify those who did not, as well as how often it was able to produce a usable result from the images taken. The reported data shows that when looking at whether the device correctly identified people who did have the condition (called "sensitivity"), the figures were 87.4% based on straightforward observation, and 87.2% after a statistical adjustment. For correctly identifying people who did *not* have the condition (called "specificity"), the figures were 89.5% based on straightforward observation and 90.7% after adjustment. In plain terms, these percentages describe how often the device's readings matched the reference standard used in the trial. The reported data also shows that in 96.1% of participants, the device was able to produce a clear enough result to be counted — meaning images were of sufficient quality for the device to give a reading. It is worth noting that these figures come from a single study population and reflect what was measured under the specific conditions of this trial. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT04347564 · results posted 18 May 2021
According to the results reported on ClinicalTrials.gov, this trial enrolled 45 participants, and all 45 completed the study with none dropping out. The trial was examining a digital eye-testing app called MacuFix®, which is designed to be used at home by people with eye conditions. The study looked at three things: how easy the app was to use, how often people used it compared to a traditional paper-based eye test called an Amsler grid, and whether using the app was linked to any change in vision-related quality of life. The reported data shows that participants rated the app's ease of use using a standard questionnaire called the System Usability Scale (SUS), where scores range from 0 (worst imaginable) to 100 (best imaginable). The average score reported was 76.7 out of 100. For test adherence — meaning how regularly people used their home eye test — the reported median (middle value) time between two self-tests was 13 days. Regarding vision-related quality of life, participants were scored using a recognised questionnaire where higher numbers mean better quality of life. The reported data shows that app users had an average change of +20.31 points, while those using the Amsler grid or no home test had an average change of −3.47 points. It is important to note these are simply the numbers recorded and reported; the data as submitted does not include further statistical detail about these figures. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT03126786 · results posted 13 May 2021
According to the results reported on ClinicalTrials.gov, this trial (NCT03126786) enrolled 71 people in total — 36 in the Active group and 35 in the Control group. The trial was measuring two things related to eye health: how well participants could read letters on a standard eye chart (known as visual acuity), and the thickness of a small central area of the retina at the back of the eye (a measurement used to detect swelling). Participants were tracked from the start of the trial through to completion, with 30 people finishing in the Active group and 33 in the Control group. The reported data shows that, for the main measure — change in the number of letters read correctly on the eye chart — the Active group improved by an average of 11.4 letters from their starting point, while the Control group improved by an average of 13.8 letters. For context, the trial's own description notes that an improvement of 15 or more letters is considered a clinically meaningful change. For the second measure — the thickness of the central retina — the Active group showed an average reduction of 212.1 microns (a micron is a tiny unit of measurement, about one-thousandth of a millimetre), while the Control group showed an average reduction of 178.6 microns. A reduction in this measurement indicates less swelling in that part of the eye. It is worth noting that these figures represent group averages as submitted by the trial sponsor, and the data does not include further detail about the range of individual results within each group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT02315170 · results posted 5 May 2021
According to the results reported on ClinicalTrials.gov, this trial involved 100 people in total — 50 in each of two groups. The trial was comparing two different devices used during eye injections: one called an "Intraocular Injection Guide" and the other a standard lid speculum (a tool that holds the eye open during a procedure). All 100 participants completed the trial with no drop-outs recorded. The reported data shows that the main thing being measured was how much discomfort participants felt during the procedure, using something called a Visual Analogue Scale (VAS). This is simply a 100-millimetre line where a person marks a point between "no pain" (0 mm) and "very severe pain" (100 mm) to show how they felt. The reported data shows that the group using the Intraocular Injection Guide marked an average of 14 mm on this scale, while the group using the standard lid speculum marked an average of 33 mm. No other outcome measures were included in the submitted results data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT03203447 · results posted 23 April 2021
According to the results reported on ClinicalTrials.gov, this trial (NCT03203447) enrolled 325 people — 162 in the Active group and 163 in the Control group — who were being treated for a condition affecting vision in the central part of the eye (macular oedema related to diabetic eye disease). The trial measured changes in vision sharpness and swelling at the back of the eye. Notably, the reported data shows that none of the participants in either group were recorded as having "completed" the study under the trial's milestone tracking, which may reflect how the trial defined completion; this was not further explained in the submitted data. The reported data shows that for the main thing being measured — how many participants gained 15 or more letters on a standard eye chart (a level considered a meaningful vision improvement) — 64 people in the Active group and 76 people in the Control group reached that milestone. For the secondary measures, the average improvement in the number of letters read correctly on the eye chart was 13.8 letters in the Active group and 20.7 letters in the Control group. When it came to swelling at the centre of the retina (the light-sensitive layer at the back of the eye), the average reduction in thickness was 353.6 microns (a unit of measurement, roughly one-thousandth of a millimetre) in the Active group and 374.7 microns in the Control group. The reported data shows that across all three measures, the numbers were higher or larger in the Control group than in the Active group, though what this means clinically is not explained in the submitted results. No other outcome data — such as side effects or quality-of-life scores — was reported in this submission. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT02949024 · results posted 19 April 2021
According to the results reported on ClinicalTrials.gov, this trial enrolled 20 people across two groups of 10: one group had not previously received treatment for their eye condition ("TX Naïve Arm"), and the other had received prior treatment ("Previous TX Arm"). Nineteen of the 20 participants completed the study — one person in the previously treated group did not finish. The trial was measuring adverse events (unexpected or unwanted health events) over six months, as well as changes in eye pressure, fluid swelling at the back of the eye, and vision scores. The reported data shows that, for the primary outcome — the number of participants who experienced adverse events — 8 out of 10 people in the treatment-naïve group and 9 out of 10 in the previously treated group had at least one adverse event during the study. No serious adverse events were reported in either group. For the secondary outcomes, eye pressure changed by −0.3 mmHg (a very small decrease) in the naïve group and +2.8 mmHg (a small increase) in the previously treated group from their starting points. The reported data shows that swelling at the centre of the back of the eye (measured in microns) started at 472.7 in the naïve group and 421.6 in the previously treated group, with reductions of 119.6 and 90.9 microns respectively after six months. Vision, measured by how many letters participants could read on a standardised eye chart, started at 67.2 letters in both groups; the naïve group showed a change of +8.5 letters and the previously treated group showed a change of +1.1 letters from their starting points. Regarding additional injections of the study treatment after the initial dose, the reported data shows varying numbers of re-treatments across both groups, with some participants receiving none and others receiving up to four additional injections over the follow-up period; the breakdown by exact number of re-treatments was reported but the data was not summarised as a single group average. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT02980874 · results posted 14 April 2021
According to the results reported on ClinicalTrials.gov, this trial (NCT02980874) enrolled 460 people in total — 231 in the active treatment group and 229 in the control group. The trial was looking at changes in vision and eye measurements in people with a condition affecting the retina (the light-sensitive layer at the back of the eye). The main thing being measured was how many participants gained 15 or more letters on a standard eye chart — a level of improvement considered meaningful in clinical research. Around 128 people in the active group and 127 in the control group completed the study, with roughly 100 people in each group not finishing. The reported data shows that, for the primary measure — the number of participants who gained 15 or more letters on the eye chart — 114 people in the active group and 127 people in the control group reached that level. For the secondary measures, the average change in the number of letters read correctly from the start of the trial was reported as an improvement of 15.5 letters in the active group and 20.5 letters in the control group (where a higher number means better reading on the chart). The trial also measured the thickness of a specific area at the centre of the retina; the reported average reduction in thickness was 354.3 microns (one micron is one thousandth of a millimetre) in the active group and 416.2 microns in the control group, where a larger reduction indicates less swelling. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT03466099 · results posted 8 December 2020
According to the results reported on ClinicalTrials.gov, this trial (NCT03466099) looked at an eye injection called KVD001 in people with diabetic eye disease. A total of 130 people were enrolled across three groups: 41 received a high dose of KVD001, 44 received a low dose, and 45 underwent a sham (pretend) procedure as a comparison group. By the end of the study, 24, 30, and 28 people in each group respectively had completed the trial, with a number of participants not finishing in each group. The reported data shows that the main thing being measured was change in best corrected visual acuity (BCVA) — essentially how well participants could read a vision chart after having their vision optimally corrected with glasses or lenses, measured in letters. The high-dose KVD001 group showed an average change of +0.8 letters from their starting point, the low-dose group showed an average change of −0.3 letters, and the sham group showed an average change of −1.8 letters. These are the raw numbers as submitted; no further statistical context was provided in the reported data. The reported data also shows two secondary (additional) measurements. One looked at the severity of diabetic eye disease using a grading scale (scored 10–85, where higher scores mean more severe disease): 0% of participants in the high-dose group and 0% in the sham group showed a meaningful improvement (a drop of two or more steps on the scale), compared with 3.2% in the low-dose group. The other secondary measurement looked at the thickness of a specific layer at the centre of the eye (central subfield thickness, measured in micrometres): the high-dose group showed an average change of +10.9 µm from baseline, the low-dose group +2.3 µm, and the sham group +8.2 µm. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT02121262 · results posted 17 November 2020
According to the results reported on ClinicalTrials.gov, this trial (NCT02121262) compared two treatments for an eye condition: laser photocoagulation and a dexamethasone (steroid) treatment. A total of 139 people were enrolled in the laser group and 145 in the dexamethasone group. The main thing the trial was measuring was any change in how well participants could read letters on a standardised eye chart — a common way to assess vision — over the course of the study. Several secondary measures were also tracked, including changes in retinal thickness (the layers at the back of the eye) and the amount of fluid leaking in the eye. The reported data shows that, on average, participants in the laser group could read approximately 1.4 more letters on the eye chart compared to where they started, while participants in the dexamethasone group could read approximately 4.3 more letters on average compared to their starting point. For the secondary measures, the reported data shows that retinal thickness decreased (improved) by an average of around 120 microns in the laser group and around 210 microns in the dexamethasone group. The amount of fluid leakage in the eye also decreased in both groups, with the laser group showing an average reduction of about 0.64 mm² and the dexamethasone group showing an average reduction of about 8.37 mm². Additionally, the reported data shows that roughly 10% of laser group participants and roughly 12% of dexamethasone group participants gained 15 or more letters of vision compared to their starting point. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT02699450 · results posted 25 September 2020
According to the results reported on ClinicalTrials.gov, this trial enrolled 227 people in total across three groups: 90 people received a 0.3 mg dose of ranibizumab (Arm A), 55 received a 1.5 mg dose of faricimab (Arm B), and 82 received a 6 mg dose of faricimab (Arm C). The trial was measuring changes in vision over 24 weeks using a standardised eye chart test called BCVA (best corrected visual acuity), where a higher score means better vision. Participants were either new to treatment or had been previously treated, and the trial tracked how many "letters" they could read on the chart compared to when they started. The reported data shows that, among participants who had never been treated before, the average gain in letters read on the eye chart at 24 weeks was 10.3 letters for the ranibizumab group, 11.7 letters for the 1.5 mg faricimab group, and 13.9 letters for the 6 mg faricimab group. Among previously treated participants (only Arms A and C were compared in this group), the reported average gain was 8.9 letters for ranibizumab and 9.6 letters for 6 mg faricimab. When looking at all participants together, the reported average gains were 9.4, 11.7, and 12.3 letters for Arms A, B, and C respectively. The reported data also shows what proportion of participants gained 15 or more letters — sometimes described as a meaningful jump in vision on this type of chart. Among treatment-naive participants, this was reported as 35.3% in the ranibizumab group, 36.0% in the 1.5 mg faricimab group, and 42.5% in the 6 mg faricimab group. For previously treated participants, the figures were 16.8% (ranibizumab) and 23.2% (6 mg faricimab). Across all participants combined, the reported figures were 28.7%, 35.3%, and 35.9% for Arms A, B, and C respectively. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT03345901 · results posted 16 September 2020
According to the results reported on ClinicalTrials.gov, this trial enrolled 18 participants and was set up to study diabetic eye disease — specifically, whether a condition called diabetic retinopathy got worse over time, or whether a related problem called diabetic macular edema (a build-up of fluid at the back of the eye that can affect vision) developed. These two things were tracked together as a combined measure. The reported data shows that none of the 18 participants were recorded as having completed the study, and all 18 were listed under "not completed." Importantly, no measurement results were reported for the primary outcome — that is, the data on whether diabetic retinopathy worsened or diabetic macular edema developed was not submitted to ClinicalTrials.gov. Because those numbers are absent from the record, it is not possible to describe what the trial found on this measure. No secondary outcome results appear in the submitted data either, so there are no additional figures to share. The reason the trial did not reach completion, and why outcome data was not reported, is not explained in the information available. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT02800642 · results posted 8 July 2020
According to the results reported on ClinicalTrials.gov, this trial enrolled 162 people, all of whom received injections of a medicine called aflibercept directly into the eye (known as intravitreal injections). The trial was looking at two main things: how many participants saw a meaningful improvement in their vision, and how often they needed to come back for injections over the course of the study. By the end, 137 people completed the trial, while 25 did not finish. The reported data shows that for the two primary (main) goals of the trial, 65.6% of participants gained 15 or more letters on a standard vision reading chart compared to when they started — gaining more letters on this chart means being able to read more lines clearly. Separately, 45.0% of participants were able to stretch the time between their injections to eight weeks or more on average. On the secondary (additional) measures, the reported data shows that the average gap between injections across all participants was about 6.37 weeks, and participants received an average of 12.2 injections over the course of the study. The trial also measured the thickness of a part of the eye called the central retina using a scanning device; the reported average thickness at the start was approximately 759.9 micrometres (millionths of a metre), and figures reported at later time points suggested reductions in that measurement, with changes of around -488 to -496 micrometres noted. Vision letter scores also appeared to change from a starting average of around 51.9 to figures in the low 70s at later time points, though the data as submitted did not clearly label each time point separately. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT04359771 · results posted 1 June 2020
According to the results reported on ClinicalTrials.gov, this trial (NCT04359771) enrolled 30 people in total, split evenly into two groups of 15 — one group treated with a Yellow MPL (micropulse laser) and one with a Diode MPL. Of those, 13 people in each group completed the study, with 2 people in each group not finishing. The trial was measuring two things over time: changes in the thickness of the central part of the retina (the layer at the back of the eye), and changes in participants' best corrected vision — that is, how well they could see even with glasses or contact lenses. The reported data shows that, for central retinal thickness (measured in micrometres, or millionths of a metre), the Yellow MPL group started at an average of about 385 µm, which reduced to around 350 µm at a middle time point and then to about 322 µm by the end. The Diode MPL group started at an average of about 374 µm, reducing to around 358 µm and then to about 340 µm. For vision, scores were measured using a logMAR scale, where a lower number means better vision. The reported data shows the Yellow MPL group's average score moved from 0.68 at the start, to 0.60, and then to 0.55 by the end. The Diode MPL group's average score moved from 0.58, to 0.57, and then to 0.52. No data on whether these differences were statistically meaningful (i.e., unlikely to be due to chance) was reported in the structured results. It is important to note that these numbers describe what was recorded in this particular group of participants over the course of the trial, and do not on their own tell us whether one approach is better than another. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01988246 · results posted 22 May 2020
According to the results reported on ClinicalTrials.gov, this trial (NCT01988246) enrolled 30 people in total — 15 in a sham (dummy) injection group and 15 in a group receiving a medicine called intravitreal aflibercept injection, which is delivered as an injection into the eye. The trial was studying people with a specific eye condition and was primarily looking at how many participants experienced side effects or unwanted events in each group, as well as measuring changes in vision and the thickness of a layer at the back of the eye called the retina. The reported data shows that, when it came to side effects or unwanted events related to the eye, 11 out of 15 people in the sham group and 10 out of 15 in the aflibercept group had at least one such event. For side effects or unwanted events not related to the eye, the reported numbers were 5 out of 15 in the sham group and 3 out of 15 in the aflibercept group. For vision, the trial used a standard eye chart test where a higher number of letters read correctly means better vision. The reported data shows the sham group gained an average of about 8.5 letters from their starting score, while the aflibercept group gained about 9.9 letters. For retinal thickness (measured in microns — a very small unit of length), the sham group showed an average reduction of about 50 microns from their starting measurement, while the aflibercept group showed an average reduction of about 18 microns. It is worth noting that this was a small trial with only 15 participants per group, and the results reported here describe what was measured and recorded — they do not tell us on their own whether one approach is better or worse than another. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT02834663 · results posted 22 April 2020
According to the results reported on ClinicalTrials.gov, this trial enrolled 25 participants, all of whom completed the study — none dropped out. All participants received the drug Lucentis (ranibizumab), an injection used in eye conditions. The trial was measuring two main things over six months: how well participants could see (using a standard eye-chart test called the ETDRS chart, where a higher score in "letters read" means better vision), and the thickness of the central part of the retina at the back of the eye (measured in micrometres, where a lower number generally means less swelling). The study also tracked tiny blood vessel abnormalities in the retina called microaneurysms — measuring how many were present, how quickly new ones appeared, and how quickly existing ones resolved. The reported data shows that for the primary (main) outcomes, the average letter score on the vision chart went from 67.6 letters at the start of the study to 76.36 letters at six months. The average central retinal thickness went from 479.12 micrometres at the start to 369.12 micrometres at six months. For the secondary outcomes, the reported data shows the average total number of microaneurysms went from 5.68 at the start to 1.60 at six months. The rate at which new microaneurysms were forming went from 2.48 per month at the start to 0.96 per month at six months. The rate at which microaneurysms were disappearing went from 4.40 per month to 0.96 per month. The overall microaneurysm turnover (new ones forming plus existing ones resolving, combined) went from 6.88 per month to 1.92 per month at six months. It is worth noting that this was a single-group study with no comparison group, and the numbers above simply describe what was recorded at the start versus at six months for the same participants. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02953938 · results posted 25 February 2020
According to the results reported on ClinicalTrials.gov, this trial (NCT02953938) enrolled 59 people in total — 29 in a group receiving a medicine called ranibizumab on its own, and 30 in a group receiving ranibizumab combined with laser treatment. By the end of the study, 28 people in each group had completed it. The trial was measuring things like how many injections of ranibizumab participants needed, changes in their vision, and changes in the thickness of a layer at the back of the eye (the central part of the retina) over 12 months. The reported data shows that, on average, the ranibizumab-only group received 4.3 injections over the study period, while the combination group received 4.1 injections. For vision (measured by how many letters participants could read on a standard eye chart), the ranibizumab-only group started at an average of about 53 letters and ended at about 75 letters — a reported gain of around 22 letters. The combination group started at about 54 letters and ended at about 70 letters — a reported gain of around 15 letters. Regarding the thickness of the central retina (measured in millimetres), both groups showed a reduction: the ranibizumab-only group went from an average of 563 mm down to 257 mm (a change of about −306 mm), and the combination group went from 553 mm down to 285 mm (a change of about −261 mm). Note that the retinal thickness unit reported in the data appears unusually large and may reflect the specific measurement scale used by the trial; the figures are presented here exactly as submitted. The reported data also shows that, at Month 12, 22 participants in the ranibizumab-only group and 16 in the combination group gained 15 or more letters of vision compared to their starting point, while 4 participants in the ranibizumab-only group and 1 in the combination group reached a reading score of 85 letters or more. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT03246152 · results posted 30 January 2020
According to the results reported on ClinicalTrials.gov, this trial enrolled 31 participants, all of whom received injections of a medicine called bevacizumab into the eye. Bevacizumab belongs to a group of treatments known as Anti-VEGF, which target a protein involved in blood vessel growth. The trial was measuring whether repeated injections of this medicine changed the tiny blood vessels at the back of the eye — specifically, an area called the Foveal Avascular Zone (FAZ, a small central zone of the retina with no blood vessels) and the density of the small blood vessels around it. It also looked at whether vision scores changed alongside any vessel changes. Twenty-eight of the 31 participants completed the trial, and three did not finish. The reported data shows three measured outcomes. First, the FAZ area — the central vessel-free zone — changed by an average of 0.03 square millimetres in the bevacizumab group. Second, the density of the tiny blood vessels across the full thickness of the retina changed by an average of −2.5 percentage points, meaning the reported figure showed a decrease. Third, vision was measured using a scale called LogMAR (where a lower number generally indicates better vision on that scale), and the average change reported was −0.21. No comparison group was included in this trial, so these figures represent changes from the start to the end of the study within the one group only. It is worth noting that the reported data does not include individual variation figures (such as ranges or confidence intervals), so the spread of results across participants is not available from what was submitted. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02181400 · results posted 23 December 2019
According to the results reported on ClinicalTrials.gov, this trial looked at a near-infrared (NIR) laser treatment for a condition affecting the back of the eye. A total of 21 people took part, divided equally into three groups of 7, each receiving the laser at a different energy level — a low dose (25 mW/cm²), a medium dose (100 mW/cm²), or a higher dose (200 mW/cm²). All 21 participants completed the trial. The main things being measured were changes in the thickness and volume of the central part of the retina (the light-sensitive layer at the back of the eye), assessed using a specialised eye scan called OCT (optical coherence tomography). A secondary measure was any change in participants' best corrected vision (how well they could see with glasses or lenses). The reported data shows that, compared to where they started, the thickness of the central retina decreased in all three groups over time. At one month, the reported average reductions in central retinal thickness were 25.2 micrometres (low dose), 29.9 micrometres (medium dose), and 58.9 micrometres (high dose). By two months, those figures were 52.5, 128.6, and 114 micrometres respectively. For total retinal volume, the changes reported were small and mixed across the groups and time points, ranging from a slight increase to a slight decrease. Regarding vision, the reported changes at one month were small improvements across all groups (4, 2, and 6 letters respectively). At two months, the low-dose group's vision change remained at plus 4 letters, while the medium- and high-dose groups showed small reductions of minus 2 and minus 3 letters compared to their starting point. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02571972 · results posted 3 December 2019
According to the results reported on ClinicalTrials.gov, this trial enrolled 14 participants, all of whom received a combination eye drop treatment called dorzolamide-timolol. Ten participants completed the study, while four did not finish. The trial was measuring changes in the structure of the back of the eye over time — specifically the thickness of a central area of the retina (the light-sensitive layer at the back of the eye), as well as the height of fluid pockets that can build up beneath it. Vision sharpness was also tracked. The reported data shows that the average thickness of the central retina area started at around 422.9 microns (a micron is one-thousandth of a millimetre) before the study began, and was recorded at 419.7, 364.5, 346.7, 326.9, and finally 334.1 microns across the study visits. For the fluid pockets directly under the retina, the reported measurements went from 111.5 microns down to 49.5 microns across the six time points. Another type of fluid pocket (called a pigment epithelial detachment) started at 275.4 microns and was recorded at 277.4, 258.9, 227.8, 275.4, and 239.9 microns over the course of the study. Vision sharpness, measured on a scale called logMAR (where a lower number generally indicates sharper vision), was reported as 0.54 at the start and 0.48 at the final visit. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02665689 · results posted 20 November 2019
According to the results reported on ClinicalTrials.gov, this trial (NCT02665689) enrolled a total of four people — two in a "Regular Glycemic Control" group and two in an "Intensified Glycemic Control" group. The trial was looking at whether tighter blood sugar management made a difference for people with diabetic eye disease who were also receiving eye injections of a medicine called ranibizumab. It planned to track vision, eye measurements, and treatment numbers over up to 24 months. The reported data shows that none of the four participants completed the trial, as the study was discontinued early. The reported data shows that because the trial ended early, the main outcome — a comparison of vision scores between the two groups at 12 months — could not be measured, and no figures were reported for it. For the secondary outcomes that were partially recorded, vision was measured using a standard letter-reading chart (where more letters read means better vision). Individual changes in letters read at available time points were reported descriptively: the two participants in the Regular Glycemic Control group showed changes of +7 and +5 letters from their starting point, while the two in the Intensified Glycemic Control group showed changes of +3, +8, +3, and +10 letters at various time points. Changes in the thickness of the central part of the eye (the macula, where swelling can affect vision) were also reported for individual participants, with some showing reductions and others showing small increases compared to their starting measurements. The total number of ranibizumab injections given and the number of laser treatments performed were also noted, but the reported data shows these figures are descriptive only and no formal comparison between groups was carried out. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00500045 · results posted 13 November 2019
According to the results reported on ClinicalTrials.gov, this trial (NCT00500045) was designed to look at a treatment group of patients and measure changes in their vision and eye health. Specifically, the trial intended to track whether participants' vision improved — measured by reading more letters on a standard eye chart — and whether the thickness of the retina (the light-sensitive layer at the back of the eye) decreased over time. The reported data shows that zero participants were recorded as having started, completed, or dropped out of the study. According to the information submitted to ClinicalTrials.gov, no results data are available for either the vision outcome or the retina thickness outcome. The explanation provided is that the lead researcher (referred to as the Principal Investigator, or PI — the doctor in charge of running the trial) has retired and left the institution where the study was conducted, and attempts to contact them were unsuccessful. As a result, no study data were able to be reported for any part of the results. The reported data shows, in short, that this trial has no retrievable outcome numbers on record. No figures were submitted for how many people took part in practice, nor for what happened to their vision or retina thickness during the study. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT03608839 · results posted 8 October 2019
According to the results reported on ClinicalTrials.gov, this trial enrolled 27 people in total, divided equally into three groups of 9. Each group received a different volume of a dexamethasone solution injected directly into the eye — either 0.01 ml, 0.03 ml, or 0.05 ml. Dexamethasone is a type of steroid medicine. The trial was measuring three things in each group: the thickness of the macula (a small but important part of the retina at the back of the eye), how well participants could see when wearing their best corrective lenses, and the pressure inside the eye. These measurements were taken at 3 days and again at 28 days after the injection. All 27 participants completed the trial. The reported data shows the following numbers at the 3-day mark for macular thickness (measured in micrometres, a very small unit of length): the 0.01 ml group averaged 438 µm, the 0.03 ml group averaged 465 µm, and the 0.05 ml group averaged 368 µm. At 28 days, those figures were 555 µm, 617 µm, and 451 µm respectively. For vision (measured using an eye chart that counts letters read correctly), the reported data shows averages of 54, 52, and 60 letters at 3 days, and 58, 51, and 64 letters at 28 days, for the 0.01 ml, 0.03 ml, and 0.05 ml groups in that order. Eye pressure (measured in mmHg, a standard pressure unit) was reported as roughly 12–13 mmHg across all three groups at both time points. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01476449 · results posted 17 May 2019
According to the results reported on ClinicalTrials.gov, this trial enrolled 20 people in total — 10 in each of two groups. Both groups received injections of a medicine called ranibizumab into the eye as a treatment for diabetic macular oedema (swelling at the back of the eye caused by diabetes). One group received injections on a fixed monthly schedule, while the other followed a "treat and extend" approach, where the time between injections was adjusted based on how the eye was responding. The trial ran for 24 months and measured changes in vision and eye anatomy. Eight participants in each group completed the full study, with two in each group not completing it. The reported data shows that, on average, participants in the monthly injection group gained 8.3 letters on a standardised eye chart (called the ETDRS chart), while those in the treat-and-extend group gained 8.5 letters, both measured over 24 months. The average number of injections given was 19.4 in the monthly group and 18.8 in the treat-and-extend group. A scan-based measurement of swelling at the centre of the retina (measured in microns) showed an average reduction of 169.0 microns in the monthly group and 146.8 microns in the treat-and-extend group. The reported data also shows that 10 out of the participants assessed in the monthly group, and 9 out of those assessed in the treat-and-extend group, reached a vision level of 20/40 or better. Additionally, 8 participants in the monthly group and 7 in the treat-and-extend group were recorded as having no detectable swelling remaining at the back of the eye. It is worth noting that this was a very small trial of only 20 people, and the numbers reported reflect only those specific participants over that study period. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT02363621 · results posted 26 April 2019
According to the results reported on ClinicalTrials.gov, this trial enrolled 101 people in total — 51 in the ranibizumab (0.3 mg injection) group and 50 in the aflibercept (2.0 mg injection) group. All but one participant finished the study. The trial was measuring two main things after eye injections: whether participants developed inflammation inside the eye, and whether they reported any pain after their injection. The reported data shows that, for eye inflammation, two separate rounds of measurement were recorded. In the first round, 6 out of 51 people in the ranibizumab group and 10 out of 50 in the aflibercept group had signs of inflammation inside the eye detected during an eye exam. In the second round of checks, those numbers were 1 out of 51 for ranibizumab and 3 out of 50 for aflibercept. For the secondary outcome — pain after the injection, rated on a scale from 0 (no pain) to 10 (severe pain) — the trial tracked how many people reported any pain above zero. The reported data shows that at the first injection visit, 28 out of 51 ranibizumab participants and 28 out of 50 aflibercept participants reported some level of pain. At the second injection visit, that was 10 out of 51 for ranibizumab and 5 out of 50 for aflibercept. No average pain scores were reported in the data, only these participant counts. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT02471651 · results posted 19 February 2019
According to the results reported on ClinicalTrials.gov, this trial (NCT02471651) involved 40 people in total — 20 in a group receiving an eye implant and 20 in a group receiving intravitreal anti-VEGF injections (a type of medicine delivered directly into the eye). The trial was measuring changes in eye health over nine months, specifically looking at the thickness of a small central area of the retina (the light-sensitive layer at the back of the eye), changes in vision sharpness, and how many treatments each group received during that period. Of the 40 who started, 15 in each group completed the trial, with 5 in each group not completing it. The reported data shows that, on average, the central retinal thickness decreased by 51 micrometres in the implant group and by 60 micrometres in the injection group over nine months — a decrease meaning the retina became thinner over that period. For vision sharpness, measured by how many letters participants could read on a standard eye chart, the implant group's average score increased by 1.5 letters and the injection group's by 1.8 letters over the same period. Regarding the number of treatments received, the implant group had a total of 43 treatments across all participants, compared with 83 treatments in the injection group over the nine months. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02259088 · results posted 1 February 2019
According to the results reported on ClinicalTrials.gov, this trial (NCT02259088) enrolled 384 participants in total — 307 in the ranibizumab (RFB002) injection group and 77 in the laser treatment group. The trial was measuring changes in vision and retinal thickness in people with diabetic macular oedema (swelling at the back of the eye caused by diabetes). Vision was measured using a standard letter-reading chart, where a higher score means better vision, and retinal thickness was measured using a scanning technology that looks at the layers of the eye. The trial ran for 12 months, with 279 participants in the injection group and 63 in the laser group completing the study. The reported data shows that, on average over the 12-month period, participants in the ranibizumab group gained approximately 6.8 letters on the vision chart from their starting score, while those in the laser group gained approximately 1.1 letters. Looking at retinal thickness (where a reduction suggests less swelling), the reported data shows average reductions ranging from around 126 to 154 micrometres in the ranibizumab group and around 33 to 73 micrometres in the laser group across the various check-in visits. Regarding individual milestones at the 12-month mark, the reported data shows that approximately 40.6% of ranibizumab participants gained 10 or more letters compared with 20.0% in the laser group, and 18.5% versus 8.0% gained 15 or more letters. Around 36.0% of the ranibizumab group and 21.3% of the laser group reached a vision score of 73 letters or above (roughly equivalent to the level needed to pass a standard driving vision test). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT02366468 · results posted 4 January 2019
According to the results reported on ClinicalTrials.gov, this trial (NCT02366468) enrolled 135 people in total — 68 in one group and 67 in the other. Participants were split into two groups based on how their eye injections were scheduled: one group received injections at the treating doctor's discretion ("DI" group), and the other received injections on an "as needed" basis ("PRN" group). The trial ran for 12 months and primarily measured changes in vision (how many letters participants could read on a standardised eye chart) as well as changes in the thickness of the retina (the light-sensitive layer at the back of the eye). The reported data shows that, on average, both groups started with similar vision scores — around 67 letters for the DI group and 65 letters for the PRN group. By the end of the study, the average score across all monthly check-ups (from month 1 to month 12) was reported as approximately 73–74 letters in both groups, representing an average improvement of about 6 letters in the DI group and about 9 letters in the PRN group from their starting scores. For retinal thickness, the reported data shows both groups started with similar measurements (around 420–431 micrometres), and both showed a reduction of roughly 107–110 micrometres by the study's end. A similar pattern was seen for a related retinal thickness measure, with reductions of around 124–126 micrometres in both groups. The reported data also shows that participants attended a similar number of clinic visits in both groups (around 12–13 visits each). The DI group received an average of about 8.4 injections and the PRN group about 7.8 injections over the 12 months. Both groups had, on average, around 1.6–1.7 periods where no injection was needed. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00493064 · results posted 21 December 2018
According to the results reported on ClinicalTrials.gov, this trial involved 63 participants, all of whom received the active treatment — a combination of niacin (a form of vitamin B3) and prednisolone acetate eye drops. The trial was looking at two things: whether participants' vision improved, measured by reading more letters on a standard eye chart (called the ETDRS chart), and whether the thickness of the back of the eye (the retina) decreased. Of the 63 people who started the trial, 52 completed it, and 11 did not finish. The reported data shows that, for the primary outcome — the number of participants who gained 15 or more extra letters on the eye chart, which would indicate a meaningful improvement in vision — the figure recorded was 63. However, it is worth noting that this number matches the total number of participants enrolled, and the way this result has been entered in the registry is unclear, so it is difficult to draw a straightforward conclusion from it without further context. For the secondary outcome, which looked at changes in retinal thickness, the reported data shows that no measurements were provided — the trial record simply states that data was not available. Because this trial had only one group (everyone received the same treatment and there was no comparison group), and because some of the reported numbers are unclear or missing, it is important to interpret these figures with caution. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT02348918 · results posted 7 December 2018
According to the results reported on ClinicalTrials.gov, this trial enrolled 217 people across nine different treatment groups. Each group received a different combination or dose of either Luminate (at doses of 0.5 mg, 1.0 mg, 2.0 mg, or 3.0 mg), Avastin (a medicine injected into the eye), or sham (dummy) injections. The trial was measuring changes in vision over 24 weeks, using a standard eye chart called the ETDRS chart, where the number of letters a person can read correctly is counted before and after treatment. The reported data shows how many extra letters — or fewer letters — each group could read on the eye chart at 24 weeks compared to when they started. The Luminate 1.0 mg group showed a change of +5.2 letters, the Luminate 2.0 mg group +2.7 letters, and the Luminate 3.0 mg group showed a change of −1.5 letters (meaning that group read fewer letters on average than at the start). The Avastin-only group showed a change of +7.0 letters. Among the combination and switch groups, the changes reported were: +7.1 letters (Avastin then Luminate 1.0 mg), +4.6 letters (Avastin then Luminate 0.5 mg), +1.4 letters (Sham then Luminate 1.0 mg plus Avastin), +3.9 letters (Sham then Luminate 0.5 mg plus Avastin), and +6.7 letters (Avastin plus sham injection). All participants who started the trial were recorded as having completed it, and no secondary outcome data was reported in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT02712008 · results posted 3 October 2018
According to the results reported on ClinicalTrials.gov, this trial (NCT02712008) enrolled 302 adults with diabetic macular oedema — a condition where fluid builds up in the central part of the retina, affecting vision. Participants were assigned to receive one of two doses of an investigational treatment called REGN910-3, or a comparator treatment called aflibercept, given by injection into the eye. The trial ran in two phases: the first 12 weeks compared the three groups side by side, and from weeks 12 to 36 some groups were switched to less frequent injection schedules. The main thing being measured was how many letters participants could correctly read on a standardised eye chart, before and after treatment. The reported data shows that at week 12, participants in all three groups read more letters correctly on average than they had at the start: the lower-dose REGN910-3 group gained an average of 6.8 letters, the higher-dose REGN910-3 group gained 8.5 letters, and the aflibercept group gained 8.8 letters. By week 36, the reported average letter gains across the various dosing-schedule groups ranged from 8.5 to 11.9 letters. For the secondary measure of retinal thickness (the depth of fluid-related swelling in the central retina, measured in microns), the reported data shows reductions across all groups at both time points — at week 12, reductions ranged from approximately 169 to 184 microns, and at week 36 from approximately 162 to 223 microns (where a larger reduction indicates less swelling). Regarding a separate measure of diabetic eye disease severity, the proportion of participants showing a meaningful improvement on a five-level scale ranged from about 13% to 21% at week 12, and from about 25% to 35% at week 36, depending on the group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01552408 · results posted 14 September 2018
According to the results reported on ClinicalTrials.gov, this trial (NCT01552408) enrolled 40 people in total — 20 in each of two groups. One group received a medicine called ranibizumab by injection into the eye, while the other group received the same injection combined with a laser eye treatment called targeted pan-retinal photocoagulation. The trial ran for 36 months (3 years) and was measuring things like how many injections participants needed, how their vision changed, how the thickness of a part of the eye called the retina changed, and how many unwanted medical events (called adverse events) occurred. Of the 40 people who started, 16 in the injection-only group and 18 in the combination group completed the full 36 months. The reported data shows that, on average, people in the injection-only group received 24.4 injections over 3 years, while those in the combination group received 27.1 injections. When it came to vision, measured using a standardised letter-reading chart, the injection-only group showed an average gain of 13.9 letters from their starting point over 36 months, while the combination group showed an average gain of 8.2 letters. For the thickness of the retina (measured in tiny units called microns), both groups showed a reduction over time — the injection-only group showed reductions of around 301–302 microns at each time point measured, and the combination group showed reductions of around 152–169 microns. Regarding significant vision changes, the reported data shows that no participants in either group lost 15 or more letters of vision by Month 12; by Month 36, none in the injection-only group and 1 in the combination group had lost that amount. For gains of 15 or more letters, the numbers of participants reaching that threshold were also reported at each time point, with the injection-only group generally showing higher counts than the combination group. The reported data also notes the number of participants who experienced adverse events (unwanted medical occurrences), with 2 participants in the injection-only group and 1 in the combination group recorded in one category, and 7 and 9 respectively in another — though the specific nature and severity of those events are not broken down further in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02299336 · results posted 7 June 2018
According to the results reported on ClinicalTrials.gov, this trial (NCT02299336) enrolled 60 people with diabetic macular edema (a condition where fluid builds up in the central part of the retina, affecting vision). All participants received a treatment called aflibercept, given as injections into the eye on an "as needed" basis — meaning injections were only given when the treating doctor judged them necessary, rather than on a fixed schedule. Of the 60 people who started, 46 completed the full study period, and 14 did not finish. The reported data shows that, on average, participants received 9.5 injections over the course of the study. When it came to vision (measured by how many letters participants could read on a standardised eye chart), the reported data shows an average change of +0.61 letters from the start to one year (week 52), and +0.83 letters from the start to two years (week 104) — these are very small shifts on the chart. At one year, 35 participants had a change of between losing 5 and gaining 5 letters from their starting vision; at two years, 30 participants fell into that same range. For those participants who also received a focal laser treatment during the study, the reported data shows an average of 7.5 injections were given before the laser and 6.7 injections after it. Regarding the thickness of the central retina (measured in microns, a very small unit of length), the reported data shows an average decrease of 7 microns at one year and an average increase of 1 micron at two years compared to the start. The number of participants recorded as having no clinically relevant fluid build-up in the retina was 39 at one year and 29 at two years. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01613716 · results posted 16 May 2018
According to the results reported on ClinicalTrials.gov, this trial (NCT01613716) involved 30 people who received a treatment called Ozurdex (a slow-release steroid implant placed in the eye). The trial was measuring two things at the three-month mark: the thickness of the central part of the retina (the light-sensitive layer at the back of the eye), and visual acuity (sharpness of vision). Of the 30 people who started, 23 completed the trial, and 7 did not finish. The reported data shows that at three months, the average central retinal thickness in the Ozurdex group was 350 micrometres (a micrometre is a very tiny unit of measurement — there are 1,000 in a millimetre). For vision, the reported average score was 56 letters on the ETDRS chart, which is a standardised eye test where a higher number of letters read correctly indicates better vision. No comparison group (such as a placebo or different treatment) was included in the reported results, so these figures represent the Ozurdex group alone. It is worth noting that the reported data does not include figures for how participants were doing before the trial started, which means it is not possible from these numbers alone to say how much, if anything, may have changed over the course of the study. Any figures for baseline measurements or longer-term follow-up were not reported in the data submitted to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01231633 · results posted 3 April 2018
According to the results reported on ClinicalTrials.gov, this trial (NCT01231633) involved 27 people in total — 14 in a group receiving a combination of two treatments (Ozurdex and Avastin) and 13 in a group receiving Avastin alone. All 27 participants completed the study. The trial was measuring changes in vision and fluid in the eye over six months, as well as how many additional Avastin injections each group needed during that time. Vision was measured using a standard eye chart test called the ETDRS chart, where a higher number of "letters" read correctly means better vision. The reported data shows that, after six months, the Ozurdex-and-Avastin group gained an average of 11.1 letters on the vision chart compared to where they started, while the Avastin-only group gained an average of 16.1 letters. Regarding additional injections needed during the six months, the reported data shows the combination group received an average of 2.5 extra Avastin injections, compared to 5.1 in the Avastin-only group. For the secondary outcome — fluid thickness at the centre of the eye as measured by a scan called an OCT — the reported data shows the combination group had readings of 703 and then 353 microns (a unit of measurement), while the Avastin-only group had readings of 790 and then 408 microns. It is not entirely clear from the submitted data whether these two sets of numbers represent baseline and six-month figures respectively, as this detail was not fully specified in the reporting. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01295112 · results posted 18 October 2017
According to the results reported on ClinicalTrials.gov, this trial involved 68 people in total, split into two groups — 35 people in Group 1 and 33 people in Group 2. All 68 participants completed the study. The trial was measuring two things: how many additional eye injections (called "PRN" or as-needed injections) of a medicine called bevacizumab each group needed over 24 weeks, and how much participants' vision changed over that same period. Vision was measured using a standard eye chart test called Best Corrected Visual Acuity (BCVA), which counts the number of letters a person can read correctly. The reported data shows that when it came to the number of extra as-needed injections needed over 24 weeks, the participants were spread across different amounts. In Group 1, the reported data shows 5 people needed no additional injections, 13 needed one, 10 needed two, 6 needed three, and 1 needed four. In Group 2, 19 people needed no additional injections, 11 needed one, 3 needed two, and none needed three or four. For the vision outcome, the reported data shows that at 24 weeks, the average change in the number of letters read correctly (compared to the start of the trial) was an increase of 16.20 letters in Group 1 and 13.55 letters in Group 2. It is worth noting that the data as submitted does not include full details about what treatment each group received or additional context around these numbers, so these figures should be interpreted carefully. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01875783 · results posted 20 September 2017
According to the results reported on ClinicalTrials.gov, this trial (NCT01875783) enrolled 385 people, all of whom completed the study with no drop-outs. All participants had diabetes and underwent a type of eye scan called OCT (Optical Coherence Tomography), which takes detailed images of the back of the eye. The trial was looking at how often this scanning process, combined with a set of guidelines for deciding who needed further care, led to patients being referred to an eye specialist for a condition called diabetic macular oedema (DME) — a diabetes-related swelling at the centre of the retina that can affect vision. The reported data shows that 44 participants were referred to a retina specialist following the OCT scan and the referral guidelines. When looking at individual eyes rather than whole participants, 59 eyes were referred for specialist review. Of the participants who were referred, 14 went on to be confirmed as having vision-threatening retina disease at their first specialist appointment. Over a follow-up period of around nine months, the reported data shows that 18 of the referred participants received treatment for DME during that time. It is worth noting that the data was reported as counts of participants or eyes rather than percentages, even though the outcome descriptions mention percentages — no percentage figures were included in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01565148 · results posted 30 August 2017
According to the results reported on ClinicalTrials.gov, this trial looked at a medicine called iCo-007, which was given as an injection into the eye, for people with diabetic macular oedema — a condition where diabetes causes swelling at the back of the eye that can affect vision. A total of 185 people started the trial, split across four groups: one group received a lower dose of iCo-007 alone (47 people), one received a higher dose of iCo-007 alone (46 people), one received the lower dose combined with laser treatment (47 people), and one received the lower dose combined with another eye injection medicine called ranibizumab (45 people). The trial's main focus was measuring how vision changed over 8 months, using a standard letter-reading chart. The reported data shows that, on average, all four groups had fewer letters read correctly on the vision chart by month 8 compared to where they started — meaning vision scores went down across the board. The lower-dose iCo-007 alone group lost an average of about 12 letters, the higher-dose group lost around 24 letters, the lower-dose plus laser group lost about 15 letters, and the ranibizumab combination group lost about 18 letters. The reported data also shows changes in retinal thickness (the swelling at the back of the eye, measured in thousandths of a millimetre): all groups showed a reduction in thickness, with the higher-dose group showing the largest reduction (around 160 units), followed by the ranibizumab combination group (about 92 units), the lower-dose alone group (about 71 units), and the laser combination group (about 54 units). Several secondary measures — including vision and thickness changes at month 12, and how long any treatment effect lasted — were listed but no numbers were reported for those outcomes. Regarding a safety-related measure, the reported data shows that no two or more participants in any single group experienced the same serious side effect considered to be related to the drug. It is important to note that this trial was an early-stage study, and the numbers reported here simply describe what was measured and recorded, not conclusions about whether any treatment is better or worse than another. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01982435 · results posted 1 August 2017
According to the results reported on ClinicalTrials.gov, this trial (NCT01982435) enrolled 27 people in total — 15 in a group receiving monthly eye injections ("Group I – Monthly") and 12 in a group following a "treat-and-extend" schedule, where injection timing was gradually spaced out ("Group II – Treat-and-Extend"). Nearly all participants finished the study: 14 of 15 in the monthly group and all 12 in the treat-and-extend group. The trial was primarily measuring how many participants experienced eye-related or non-eye-related unwanted effects (called adverse events), and secondarily tracking changes in vision and the thickness of a part of the retina (the central fovea — the spot at the back of the eye responsible for sharp, central vision). The reported data shows that, for eye-related adverse events that were not classified as severe, 9 participants in the monthly group and 5 in the treat-and-extend group recorded at least one such event across the various time points measured. For severe eye-related adverse events, zero participants in either group were reported to have experienced one. For non-eye-related adverse events, the reported data shows a range of counts across different categories and time points — for example, 14 participants in the monthly group and 12 in the treat-and-extend group were recorded under one non-severe non-eye-related category, while 6 and 3 participants respectively appeared in one of the severe non-eye-related categories. The breakdown of exactly which events fell into which specific category was not detailed in the structured data provided. For the secondary outcomes, the reported data shows that average vision (measured by the number of letters read correctly on a standard eye chart) changed by 0.7 letters in both groups at 6 months, and by 2.1 letters in the monthly group and 7.4 letters in the treat-and-extend group at 12 months. For retinal thickness at the central fovea, the monthly group showed an average reduction of 28.8 microns at 6 months and 80.9 microns at 12 months, while the treat-and-extend group showed an average increase of 104.1 microns at 6 months and a reduction of 124 microns at 12 months. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01571232 · results posted 31 May 2017
According to the results reported on ClinicalTrials.gov, this trial (NCT01571232) enrolled 20 people in total — 10 in a group receiving Ozurdex (a slow-release steroid implant injected into the eye) and 10 in a group receiving Avastin (an injection also given into the eye). Nine people in each group completed the study; one person in each group did not finish. The trial was measuring changes in vision and the health of the central part of the retina (the macula) over six months, comparing the two treatments. The reported data shows that for vision, measured using a standard eye chart scored in letters (called ETDRS letters — higher scores mean better vision), the Ozurdex group averaged 67.8 letters at the start and 69.6 letters at six months, while the Avastin group averaged 71.9 letters at the start and 72.9 letters at six months. For the thickness of the central retina (measured in tiny units called microns — lower thickness can indicate less swelling), the Ozurdex group averaged 385.9 microns at the start and 305.4 microns at six months, while the Avastin group averaged 341.5 microns at the start and 324.3 microns at six months. For macular sensitivity (how well the central retina detects light, measured in decibels), the Ozurdex group recorded 5.6 at the start and 7.4 at six months, while the Avastin group recorded 10.7 at both time points. For a measure of the retina's electrical response (called multifocal ERG amplitude), the Ozurdex group averaged 27.8 at baseline and 40.9 at six months, while the Avastin group averaged 34.4 at baseline and 30.3 at six months. The secondary outcome on macular leakage observed through a dye-based eye scan (fluorescein angiography) had no numerical data reported. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01449682 · results posted 31 May 2017
According to the results reported on ClinicalTrials.gov, this trial (NCT01449682) enrolled 10 people in total, split evenly into two groups of 5. Both groups received an eye implant called Ozurdex, but on different schedules — one group received it "as needed" (called PRN), and the other received it on a fixed schedule every 16 weeks. The trial was measuring changes in macular function (how well the central part of the retina responds to light and detail), visual sharpness, and retinal thickness over 48 weeks. Eight of the 10 participants completed the study, with one person from each group not finishing. The reported data shows the following numbers across the two main measures of macular function. For sensitivity of the macula (measured in units called decibels, or dB — where a higher number means the retina is responding more strongly), the PRN group recorded values of 2.7 dB at baseline and 4.2 dB at 48 weeks, while the every-16-weeks group recorded 12.7 dB at baseline and 10.7 dB at 48 weeks. For a separate electrical test of retinal activity (measured in units called nV/deg²), the PRN group recorded 3.61 at baseline and 18.20 at 48 weeks, while the every-16-weeks group recorded 6.62 at baseline and 30.18 at 48 weeks. For visual sharpness (measured in letters read on an eye chart), the PRN group recorded 46.4 letters at baseline and 27.8 at 48 weeks, while the every-16-weeks group recorded 55.6 letters at baseline and 53.2 at 48 weeks. For retinal thickness (in microns — tiny units of measurement), the PRN group recorded 501.7 microns at baseline and 361.4 at 48 weeks, while the every-16-weeks group recorded 353.5 microns at baseline and 326.7 at 48 weeks. It is worth noting that this was a very small trial with only five participants per group, which means these numbers should be interpreted with considerable caution. The reported data describes what was observed and measured in this particular group of participants only, and no conclusions about broader populations can be drawn from these figures alone. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01077401 · results posted 28 April 2017
According to the results reported on ClinicalTrials.gov, this trial looked at two different doses of a medicine called ranibizumab — a 0.5 mg dose and a 2.0 mg dose. A total of 152 people took part (77 in the lower-dose group and 75 in the higher-dose group). The trial measured deaths due to heart attack as its main (primary) outcome, and also tracked changes in vision sharpness and retinal thickness (the thickness of the light-sensitive layer at the back of the eye) over six months as secondary outcomes. The reported data shows that, for the primary outcome of deaths due to heart attack, 1 participant in the 0.5 mg group and 3 participants in the 2.0 mg group died from this cause during the study. For vision sharpness, scores are measured in "letters" on a standard eye chart — a higher number means more letters could be read compared to the start of the study. The reported data shows an average change of 9.34 letters in the 0.5 mg group and 7.04 letters in the 2.0 mg group. For retinal thickness, the reported data shows an average change of 168.57 µm (micrometres, a very small unit of measurement) in the 0.5 mg group and 159.69 µm in the 2.0 mg group. It is worth noting that 18 people in the lower-dose group and 21 in the higher-dose group did not complete the study, though the reasons were not detailed in the reported data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01976312 · results posted 24 April 2017
According to the results reported on ClinicalTrials.gov, this trial (NCT01976312) enrolled 252 people in total — 190 received injections of a medicine called ranibizumab (0.5 mg), and 62 received a sham (dummy) injection as a comparison group. The trial was measuring changes in vision, specifically how many letters participants could read on a standardised eye chart, as well as changes in the thickness of a central part of the retina (the light-sensitive layer at the back of the eye). By the end of the study, 173 people in the ranibizumab group and 53 in the sham group had completed the full trial. The reported data shows that the main result — the average change in letters read on the eye chart from the start of the trial through to three months — was an improvement of 11.3 letters in the ranibizumab group, compared to a decline of 2.7 letters in the sham group. Over the longer follow-up period of 12 months, the reported average change was an improvement of 12.4 letters in the ranibizumab group and 3.2 letters in the sham group. The reported data also shows changes in retinal thickness (measured in microns): in the ranibizumab group, the central retinal thickness decreased by roughly 393–433 microns across the early time points, while in the sham group the decreases in early time points were much smaller (around 8–84 microns), though both groups showed larger and more similar reductions at the later time points. The reported data also shows that, looking at the number of participants who gained 15 or more letters of vision at various points, this occurred in 56 people in the ranibizumab group compared to 2 in the sham group at one measured time point. Separately, the number of participants who avoided losing 15 or more letters (considered a meaningful drop in vision) was reported as consistently high in both groups across the study visits. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01710839 · results posted 11 April 2017
According to the results reported on ClinicalTrials.gov, this trial (NCT01710839) enrolled 30 participants in total. Twenty-four people were placed in a group receiving a combination of targeted pan-retinal laser treatment plus a medicine called ranibizumab (injected into the eye), while six people received ranibizumab injections alone. The trial ran over 12 months and was primarily looking at two things: how many eye injections each person needed over that period, and how much their vision changed, measured using a standard eye-chart test called ETDRS (where a higher score means better vision). It is worth noting that none of the six participants in the ranibizumab-only group completed the study, which means the results for that group should be interpreted with considerable caution. The reported data shows that, on average, participants in the combination laser-plus-ranibizumab group received 8.7 injections over 12 months, compared with 9.5 injections in the ranibizumab-only group. For vision change, the combination group showed a reported average improvement of 14.9 letters on the ETDRS chart from their starting point, while the ranibizumab-only group showed an average improvement of 10.7 letters. For two secondary outcomes — changes in the area of blood flow and oxygen supply to the retina, and changes in a small central zone of the eye called the foveal avascular zone — no numerical results were reported in the submitted data. Regarding a condition called neovascularisation (where abnormal new blood vessels grow in the eye), 8.33% of participants in the combination group were reported to develop this, compared with 0% in the ranibizumab-only group. Adverse events (unwanted side effects or medical occurrences) were reported in 17 participants in the combination group and 2 in the ranibizumab-only group, with a further 2 and 0 participants respectively recorded in what appears to be a separate adverse event category — though the specific detail of those categories was not fully described in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00407381 · results posted 31 March 2017
According to the results reported on ClinicalTrials.gov, this trial enrolled 126 people in total, split evenly across three groups of 42 participants each. One group received a medicine called ranibizumab on its own, another received laser treatment on its own, and the third received laser treatment combined with ranibizumab. The trial was measuring changes in vision — specifically, how many letters participants could read on an eye chart (called Best Corrected Visual Acuity, or BCVA) after six months of treatment. The reported data shows the following average changes in the number of letters read correctly after six months. In the ranibizumab-only group, participants gained an average of 7.24 letters. In the laser-only group, participants recorded an average change of −0.43 letters, meaning they read very slightly fewer letters on average than they did at the start. In the group that received both laser and ranibizumab together, participants gained an average of 3.8 letters. Numbers of participants who completed the study were 39, 38, and 40 in the three groups respectively. No secondary outcome measure data was included in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01599650 · results posted 10 November 2016
According to the results reported on ClinicalTrials.gov, this trial (NCT01599650) enrolled 455 people with vision loss caused by a branch retinal vein occlusion — a blockage in a small blood vessel in the eye. Participants were split into three groups: 183 received ranibizumab injections alone, 180 received ranibizumab injections combined with laser treatment, and 92 received laser treatment alone. The trial ran for 24 months and was primarily measuring changes in vision sharpness (how many letters participants could read on a standard eye chart, scored out of 100). The reported data shows that at the start of the trial, all three groups had similar average vision scores — around 57–60 letters. By the six-month mark (the main measurement point), the ranibizumab-alone group's average score had risen to about 74 letters (a reported gain of roughly 15 letters), the ranibizumab-plus-laser group's average rose to about 71 letters (also a reported gain of roughly 15 letters), and the laser-alone group's average rose to about 63 letters (a reported gain of roughly 6 letters). These trends continued through to 12 and 24 months, with the reported data showing the two ranibizumab groups continuing to show larger average gains than the laser-only group. Regarding the proportion of participants who gained 15 or more letters at six months, the reported figures were approximately 83% in the ranibizumab-alone group, 89% in the ranibizumab-plus-laser group, and 70% in the laser-alone group. Participants in the two ranibizumab groups received an average of approximately 11 injections each over the 23-month treatment period. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
Read the full trial page · View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01994291 · results posted 17 October 2016
According to the results reported on ClinicalTrials.gov, this trial (NCT01994291) enrolled 198 participants in total across three groups: 99 people received a daily oral tablet called PF-04634817 (200 mg), 43 received a placebo tablet plus eye injections of ranibizumab at a lower dose (0.3 mg), and 56 received a placebo tablet plus eye injections of ranibizumab at a higher dose (0.5 mg). The trial ran for 12 weeks and was measuring changes in vision, retinal thickness, and fluid leakage at the back of the eye in people with a diabetic eye condition. Of those who started, 84, 36, and 47 participants respectively completed the study in each group. The reported data shows that for the main thing being measured — how many letters participants could read on a standard eye chart compared to the start of the trial — the PF-04634817 group gained an average of 1.55 letters, while the ranibizumab injection groups gained an average of around 3.87 to 4.03 letters (or roughly 3.96 letters when those two injection groups were combined). For one of the secondary measures — the proportion of people who gained 15 or more letters on the eye chart — the reported figures were approximately 6.9% in the PF-04634817 group, compared to around 21% and 11.3% in the two ranibizumab groups (roughly 15.4% combined). Regarding retinal thickness (a measure of swelling at the back of the eye), the PF-04634817 group showed an average increase of 1.73 micrometres, while the ranibizumab groups showed average reductions of around 64 to 112 micrometres. Similarly, the area of fluid leakage at the back of the eye increased by an average of 1.02 mm² in the PF-04634817 group, while it decreased by an average of around 5.32 to 6.96 mm² in the ranibizumab groups. The reported data also shows small changes in a scale used to grade the severity of diabetic eye disease, with the PF-04634817 group showing a slight increase of 0.11 steps and the ranibizumab groups showing slight decreases of 0.23 to 0.44 steps. Blood concentration levels of PF-04634817 were also measured at various time points during the study, with figures ranging from approximately 160 to 752 nanograms per millilitre, though the specific time points for each measurement were not detailed in the submitted results data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01872611 · results posted 2 August 2016
According to the results reported on ClinicalTrials.gov, this trial (NCT01872611) enrolled 605 people in total — 301 assigned to nepafenac (an anti-inflammatory eye drop) and 304 assigned to a vehicle (a comparison drop without the active ingredient), both used after cataract surgery. The trial was measuring two main things: whether participants' vision improved significantly after surgery, and whether a condition called macular oedema (swelling at the back of the eye) developed within 90 days of the operation. Vision was tested using a standard eye chart, and swelling was measured using a specialised eye scan. The reported data shows that for the first primary measure — vision improving by 15 or more letters on the eye chart by Day 14 and staying improved through Day 90 — 48.8% of the nepafenac group and 50.5% of the vehicle group reached that point. For the second primary measure — developing macular oedema within 90 days — 5.9% of the nepafenac group and 14.3% of the vehicle group met the definition for this outcome. On the secondary measures, the reported data shows that at Day 90, 65.4% (nepafenac) and 65.9% (vehicle) had a 15-or-more letter vision improvement; at Day 60 those figures were 68.9% and 62.1% respectively. Regarding vision loss, 18.7% of the nepafenac group and 16.7% of the vehicle group had a drop of more than 5 letters at some point, while a drop of more than 10 letters was recorded in 10.7% and 8.9% respectively. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01951066 · results posted 1 August 2016
According to the results reported on ClinicalTrials.gov, this trial involved 20 people in total, split into two groups of 10. It used a "crossover" design, meaning both groups received both treatments but in opposite orders — one group received a dexamethasone implant (a slow-release steroid injection into the eye) first, followed by an anti-VEGF injection (a different type of eye injection), while the other group received the treatments in reverse order. The trial was measuring whether changes in certain proteins in the eye — called "propermeability factors," which are substances that can cause fluid leakage — were linked to changes in eye swelling (oedema) after each treatment. All 20 participants completed both phases of the trial. The reported data shows the results as a "correlation coefficient" — a number between -1 and +1 that indicates how closely two things move together, where a higher number suggests a stronger relationship. For the dexamethasone implant group, the reported correlation values between changes in these proteins and changes in eye swelling ranged from approximately 0.40 to 0.47 across six different measurements. For the anti-VEGF group, the reported values ranged from approximately -0.004 to 0.369 across the same six measurements. The data does not include labels identifying which specific protein each individual measurement refers to, so a direct protein-by-protein comparison cannot be described here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01535261 · results posted 3 June 2016
According to the results reported on ClinicalTrials.gov, this trial enrolled 357 people, all of whom received the study treatment, ranibizumab (an injection given into the eye). A total of 307 people completed the study, while 50 did not finish. The trial was measuring changes in participants' vision over two years, specifically using a standardised letter-reading chart (where a higher score means better vision, and a positive change from the starting point means vision improved on the chart). The reported data shows that, on average, participants' vision scores increased by 12.3 letters from their starting point by 12 months, and by 12.1 letters by 24 months. When looking at the average change across all measurement points throughout the study (from the start up to 12 months, and up to 24 months), the reported averages were 11.8 and 12.1 letters respectively. The data also shows that after treatment was paused (once vision had appeared to stabilise), scores shifted by an average of −2.7 letters by month 12 and −2.5 letters by month 24 — meaning the average score was slightly lower during the pause period compared to when treatment stopped. In terms of how many individuals saw their scores change by set amounts, by 12 months the reported data shows 296 participants gained at least 1 letter, 275 gained at least 5 letters, 227 gained at least 10 letters, 175 gained at least 15 letters, and 32 gained at least 30 letters. Similar numbers were reported at 24 months. Additionally, 169 participants reached a score of 73 letters or above (a level roughly equivalent to what is considered functional driving vision on a traditional eye chart) by month 12, and 161 reached that level by month 24. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01918371 · results posted 26 May 2016
According to the results reported on ClinicalTrials.gov, this trial enrolled two separate groups of people with eye conditions affecting the retina: 166 people with retinal vein occlusion (RVO, a blockage of a blood vessel in the eye) and 157 people with diabetic macular oedema (DME, swelling at the centre of the retina related to diabetes). All but one participant in each group completed the study. The trial was measuring how many people, after receiving injections into the eye, met two targets at the same time: vision of 20/40 or better on an eye chart (meaning they could read at least 14 out of 20 lines correctly) and a reduction in retinal thickness to within a specific range, as measured by a laser-based eye scan called OCT. The reported data shows these combined targets were tracked at six time points — after injections 2 through 7. For the RVO group, the percentage of participants meeting both targets at each time point was reported as approximately 26%, 29%, 27%, 37%, 25%, and 32% respectively. For the DME group, the corresponding figures were approximately 16%, 16%, 18%, 22%, 19%, and 20%. In both groups, the proportion meeting both targets varied across the injection time points, with the highest figures appearing around the fifth injection for each group. No secondary outcome measure data was included in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02118831 · results posted 19 May 2016
According to the results reported on ClinicalTrials.gov, this trial (NCT02118831) enrolled 56 people in total, split across three groups: 21 received aflibercept, 15 received bevacizumab, and 20 received ranibizumab. All participants who started the study completed it — none dropped out. The trial was measuring how much of each medicine entered the bloodstream after eye injections, and how levels of a naturally occurring protein in the body called VEGF (a growth factor involved in blood vessel development) changed over the course of treatment. The reported data shows that the main outcome — the peak amount of each medicine detected in the blood — was measured after the first and third injections. After the first injection, peak blood levels were 0.45 nM for aflibercept, 0.76 nM for bevacizumab, and 0.11 nM for ranibizumab (nM is simply a unit used to measure very small concentrations). After the third injection, the reported figures were 0.58 nM for aflibercept, 1.47 nM for bevacizumab, and 0.07 nM for ranibizumab. The reported data also shows a secondary measurement: the lowest detectable levels of free VEGF in the blood at the start of the study compared to four months later (one month after the last treatment). At baseline, levels were 19.2 pg/mL (another unit for tiny concentrations) for aflibercept, 22.5 pg/mL for bevacizumab, and 17.0 pg/mL for ranibizumab. At the four-month mark, those figures were reported as 11.3 pg/mL, 10.6 pg/mL, and 17.0 pg/mL respectively. No further interpretation of these changes was included in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00090519 · results posted 16 May 2016
According to the results reported on ClinicalTrials.gov, this trial enrolled 731 people with diabetic eye disease — 371 received a medicine called ruboxistaurin and 360 received a placebo (a dummy pill with no active ingredient). By the end of the study, 298 people in the ruboxistaurin group and 285 in the placebo group had completed the trial. The trial was measuring several things related to diabetic eye and kidney health over 36 months, including how long a specific type of swelling in the centre of the eye (called diabetic macular oedema) lasted, how well participants could read a vision chart, and how well their kidneys were filtering blood. The reported data shows that for the main outcome — how long, on average, participants had swelling at the centre of the macula — the ruboxistaurin group averaged 1.72 months per person, compared to 1.69 months in the placebo group. For vision tested using a standard letter chart at 36 months, the average change from the starting point was a loss of 1.14 letters in the ruboxistaurin group and a loss of 2.30 letters in the placebo group. For contrast sensitivity (the ability to distinguish shades), the change from baseline was −0.54 in the ruboxistaurin group and −1.06 in the placebo group. Regarding progression of diabetic eye disease, 43 participants in the ruboxistaurin group and 48 in the placebo group were reported to have experienced progression. For a measure of kidney filtering function, the reported change from baseline was −5.55 units in the ruboxistaurin group and −7.92 units in the placebo group. The reported data also shows that 32 participants in the ruboxistaurin group and 27 in the placebo group underwent a laser eye treatment called focal/grid photocoagulation during the study. It is worth noting that these numbers describe what was measured and recorded in this specific trial — they do not tell us on their own whether any difference between the groups is meaningful or due to chance. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01610557 · results posted 27 April 2016
According to the results reported on ClinicalTrials.gov, this trial involved 56 participants across four groups during the first 36-week phase, where different sequences of two eye injection medicines — ranibizumab and bevacizumab — were tested in people with a retinal eye condition. After that phase, 55 participants moved into a longer extension phase where they received injections as needed. The trial was measuring changes in two things: how well participants could read letters on a standard eye chart (called an ETDRS chart), and changes in the thickness of a specific layer at the back of the eye (the central retina), measured using a scanning technology called OCT. The reported data shows that, over the 36-week crossover phase, participants receiving bevacizumab gained an average of 5.3 letters on the eye chart from where they started, while those receiving ranibizumab gained an average of 6.6 letters. For the retinal thickness measurement, the reported data shows an average reduction (thinning) of 89 micrometres in the bevacizumab group and 137 micrometres in the ranibizumab group. A reduction in retinal thickness was the expected direction of change being tracked in this trial. No data from the extension phase outcomes was reported in the structured results provided. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01292798 · results posted 22 April 2016
According to the results reported on ClinicalTrials.gov, this trial enrolled 43 participants who received a 2.0 mg dose of a medicine called ranibizumab, which is injected into the eye. The trial was looking at whether this treatment could improve vision and reduce swelling at the back of the eye (called diabetic macular oedema, or DME — a complication of diabetes that can affect sight). All 43 participants completed the study, though 29 of them were noted to still have persistent DME after the first three months. The trial measured changes in vision and eye swelling over six months. Note that the results data as submitted combines both the 0.5 mg and 2.0 mg dose groups together, so the figures below reflect that combined group. The reported data shows that, on average, participants' vision scores — measured using a standard eye chart (where a higher score means better vision) — started at around 58.8 letters and rose to approximately 67.6 letters by six months, representing a reported average increase of about 8.8 letters. For the eye swelling measurement, the reported data shows the average thickness of the central part of the retina (the light-sensitive layer at the back of the eye) started at around 500.6 microns (a micron is a tiny unit of measurement) and reduced to approximately 335.2 microns — a reported average decrease of about 165.4 microns. When it came to the qualitative assessment of DME, the reported data shows that 42% of participants had complete resolution of the swelling, while 58% had partial or no resolution. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01783886 · results posted 5 April 2016
According to the results reported on ClinicalTrials.gov, this trial (NCT01783886) enrolled 381 people in total — 127 in each of three groups. Two groups received injections of a medicine called intravitreal aflibercept (one group every four weeks, another every eight weeks after an initial period), while the third group received a laser treatment to the eye called macular laser photocoagulation. The trial was mainly measuring changes in vision sharpness over 52 weeks, using a standard eye-reading chart test (called an ETDRS letter score, where a higher number of letters read correctly means better vision). The reported data shows that, at 52 weeks, the average change in letters read correctly from the start of the trial was +13.7 letters for the every-four-weeks injection group, +12.8 letters for the every-eight-weeks injection group, and −0.2 letters (essentially no change) for the laser group. For the secondary measurements, the reported data shows that approximately 70.9%, 62.7%, and 23.4% of participants in those three groups respectively gained at least 10 letters of vision. Around 43.3%, 36.5%, and 12.1% gained at least 15 letters. The reported data also shows changes in retinal thickness (a measure of swelling at the back of the eye): on average, the injection groups showed reductions of around 239 and 235 micrometres respectively, compared with around 109 micrometres in the laser group. A patient-reported quality-of-life score focused on close-up activities (such as reading) changed by +6.65 and +7.28 points in the two injection groups, and +0.04 points in the laser group, on a scale of 0 to 100. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01003106 · results posted 15 March 2016
According to the results reported on ClinicalTrials.gov, this trial enrolled people with two types of retinal vein occlusion — a blockage of blood vessels at the back of the eye. There were two main conditions studied: branch retinal vein occlusion (BRVO) and central retinal vein occlusion (CRVO). In the first six months, 22 people with BRVO received a 0.5mg dose of a medicine called ranibizumab, and 20 received a 2.0mg dose; for CRVO, 19 received 0.5mg and 20 received 2.0mg. From month 6 through to month 36, participants were reassigned into groups receiving ranibizumab on an as-needed basis, either alone or combined with laser treatment. The trial was measuring how often and how seriously unwanted medical events occurred (the primary focus), as well as changes in vision and retinal thickness (the secondary focus). The reported data shows that, for the primary measure — tracking unwanted medical events — 17 out of the BRVO participants and 12 out of the CRVO participants experienced ocular (eye-related) events, while 37 BRVO participants and 35 CRVO participants experienced non-ocular events (the data does not break these two categories out separately in the submitted results). For vision, measured in "letters" read on an eye chart, the reported data shows average gains of 12.1 letters (BRVO, 0.5mg) and 14.6 letters (BRVO, 2.0mg) over the first six months, and 15.5 letters (CRVO, 0.5mg) and 15.8 letters (CRVO, 2.0mg). From month 6 to month 36, the reported changes in vision varied: the BRVO as-needed-only group averaged a further gain of 3.1 letters, while the BRVO as-needed-plus-laser group averaged a change of −2.6 letters; the CRVO as-needed-only group averaged −6.7 letters, and the CRVO as-needed-plus-laser group averaged +0.4 letters. The reported data also shows changes in retinal thickness (measured in microns, a very small unit of length) at the centre of the eye. Over the first six months, average thickness reduced by 203.3 microns (BRVO, 0.5mg), 292.1 microns (BRVO, 2.0mg), 253.5 microns (CRVO, 0.5mg), and 396.1 microns (CRVO, 2.0mg). From month 6 to month 36, further changes were smaller and varied by group: the BRVO as-needed-only group showed a further reduction of 3.2 microns, while the BRVO as-needed-plus-laser group showed an increase of 36.6 microns; the CRVO as-needed-only group showed an increase of 19.1 microns, and the CRVO as-needed-plus-laser group showed an increase of 58.8 microns. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00133952 · results posted 28 January 2016
According to the results reported on ClinicalTrials.gov, this trial enrolled 157 people in the placebo group and 152 people in the ruboxistaurin group, for a total of 309 participants. The trial ran for up to 48 months and was primarily measuring whether people experienced a significant, lasting drop in vision — specifically, losing 15 or more letters on a standard eye chart for the final six months of the study. A number of secondary measurements were also taken, including changes in the thickness of the central part of the retina (the light-sensitive layer at the back of the eye) and changes in the ability to see objects with low contrast, all assessed at the 24-month mark. The reported data shows that, for the main outcome, 3.4% of participants in the placebo group and 2.2% of participants in the ruboxistaurin group experienced that sustained, significant drop in vision over the course of the study. For the secondary outcomes, the average increase in retinal thickness within the central retinal zone was reported as 12.8 micrometres (a micrometre is one-thousandth of a millimetre) in the placebo group and 9.4 micrometres in the ruboxistaurin group at 24 months. The number of eyes that developed significant swelling at the centre of the retina at any point up to 24 months was 77 in the placebo group and 76 in the ruboxistaurin group. For contrast sensitivity (the ability to distinguish objects from their background), the average change was a loss of 1.1 letters in the placebo group and 0.6 letters in the ruboxistaurin group. The data for time to a specific laser eye treatment (focal photocoagulation) was not reported. The change in retinal thickness at the very centre of the macula showed an average increase of 10.5 micrometres in the placebo group and 13.1 micrometres in the ruboxistaurin group at 24 months. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01976650 · results posted 13 January 2016
According to the results reported on ClinicalTrials.gov, this trial (NCT01976650) involved 724 people who received the treatment OZURDEX® (a slow-release eye implant). The trial was measuring two things: how many participants experienced unwanted or harmful events (called adverse events or adverse drug reactions), and how many participants showed a meaningful improvement in their vision — specifically, whether they could read 15 or more extra letters on an eye chart after treatment. Of the 724 who started, 718 completed the study, and 6 did not finish. The reported data shows that, for the primary outcome, 55 participants experienced an adverse event (an unwanted sign, symptom, or illness noted during the study), and 50 participants experienced an adverse drug reaction (a harmful or unintended reaction that could not be ruled out as being linked to the treatment). For the secondary outcome, the reported data shows that 94.36% of participants — meaning roughly 94 out of every 100 people in the study — were recorded as having improved their reading of the eye chart by 15 or more letters in the eye being studied. It is worth noting that the data as submitted lists two separate figures for the primary outcome but does not provide a further breakdown explaining the split, so the full context of those two numbers is not entirely clear from the reported data alone. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01692938 · results posted 30 November 2015
According to the results reported on ClinicalTrials.gov, this trial enrolled 32 people in total — 16 who had no retinal disease and 16 who had a retinal disease affecting the eye. The trial was measuring how consistently a type of eye test called microperimetry produces the same results when repeated. Microperimetry measures how well a person can detect light in different parts of their vision, and the results are recorded in decibels (a unit used to express the strength of that response). Of the 32 people who started the trial, 24 completed it — 12 from each group — and it was these 24 participants whose results were used in the main analysis. The reported data shows that, on average, people with no retinal disease had a mean test result of 16.16 decibels, while people with retinal disease had a mean result of 12.23 decibels. The trial also looked at how repeatable the results were when the same person was tested three times in a row using the same device and operator. The reported data shows the same figures were recorded for repeatability — 16.16 decibels for the no-disease group and 12.23 decibels for the retinal disease group — though the specific breakdown of the repeatability calculations (such as the spread of individual results around those averages) was not separately detailed in the submitted data beyond these figures. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT02036424 · results posted 3 November 2015
According to the results reported on ClinicalTrials.gov, this trial (NCT02036424) enrolled 50 people in total — 23 in the Bevacizumab group and 27 in the Ozurdex group. All 50 participants completed the study. The trial was measuring two things over seven months: changes in vision (measured by how many letters a person could read on a standardised eye chart, called the ETDRS method) and changes in the thickness of a specific layer at the back of the eye (the central part of the retina, measured in microns using a scanning technique called Optical Coherence Tomography, or OCT). The reported data shows that, on average, both groups had a small improvement in the number of letters they could read on the eye chart — the Bevacizumab group improved by 5.6 letters and the Ozurdex group improved by 5.8 letters. For retinal thickness, the reported data shows a reduction (negative numbers meaning the retina became thinner) in both groups: the Bevacizumab group had an average reduction of 13 microns, while the Ozurdex group had an average reduction of 122 microns. These are the numbers as submitted to the registry; no further breakdown of individual results was reported in the structured data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT02472366 · results posted 16 September 2015
According to the results reported on ClinicalTrials.gov, this trial (NCT02472366) enrolled 16 people in total across two groups: 6 people received laser treatment alone, and 10 people received laser treatment combined with an anti-VEGF injection (a type of eye injection). The trial was measuring changes in vision and eye health over time, including how well participants could read letters on a standardised eye chart (called an ETDRS chart), pressure inside the eye, and the thickness and volume of the central part of the retina (the light-sensitive layer at the back of the eye). Of the 16 who started, 15 completed the study — one person in the laser-only group did not finish. The reported data shows the following changes from the start of the study to the end. For the main measure — change in the number of letters read correctly on the eye chart — the laser-only group showed a change of 3.5 letters, while the laser-plus-injection group showed a change of 0.9 letters. For pressure inside the eye, the laser-only group showed a change of 1.7 mmHg and the laser-plus-injection group showed 2.9 mmHg. For the thickness of the central retina, the laser-only group showed a change of −362.2 microns and the laser-plus-injection group showed −251.3 microns. For the volume of the central retina, the laser-only group showed a change of −1.610 mm³ and the laser-plus-injection group showed −1.137 mm³. Whether these changes represent increases or decreases from baseline (the starting point) is not fully detailed in the reported data beyond the numbers themselves. The reported data also includes an additional analysis looking only at participants whose natural lens had been surgically removed (called pseudophakic patients). In that smaller subgroup, the letter-reading score change was reported as 5.6 letters for the laser-only group and 9.4 letters for the laser-plus-injection group. It is worth noting this was a very small trial with only 16 participants, so the numbers should be interpreted with that context in mind. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT02080091 · results posted 10 August 2015
According to the results reported on ClinicalTrials.gov, this trial (NCT02080091) enrolled 25 adults with a condition called chronic diabetic macular oedema (DME) — a type of swelling at the back of the eye related to diabetes. The trial was measuring changes in vision, the occurrence of eye-related unwanted events, and the thickness of a specific layer at the back of the eye. The reported data shows that none of the 25 participants were recorded as having formally "completed" the study under the trial's own definitions, though all 25 were counted as having started. The reported data shows that for vision, the average change from the starting point was −0.025 on the LogMAR scale — a scale used to measure eyesight where a lower number generally indicates better vision than a higher one. Out of the 25 participants, 7 were reported as experiencing ocular adverse events, meaning unwanted events specifically involving the eye. For the secondary outcome, the reported average thickness of the central part of the retina (the light-sensitive layer at the back of the eye) was 357.0 microns. No further breakdown of these figures — such as how much thickness changed from the start — was included in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01441102 · results posted 8 June 2015
According to the results reported on ClinicalTrials.gov, this trial looked at a single group of 7 people who were given a medicine called dextromethorphan hydrobromide. Of the 7 who started, 4 completed the trial and 3 did not finish. The trial was measuring two main things over time: changes in the thickness of the retina (the light-sensitive layer at the back of the eye), and changes in best-corrected visual acuity — that is, how many letters a person could read on a standard eye chart when wearing their best possible glasses or contact lenses. These measurements were taken at several points: 6, 12, 18, and 24 months after the start of the trial. The reported data shows the following percentage changes in retinal thickness in the study eye compared to where participants started: at 6 months, thickness had changed by −7.89% (a decrease); at 12 months, by +6.54% (an increase); at 18 months, by −0.99% (a very slight decrease); and at 24 months, by −7.44% (a decrease). For the vision chart readings, the reported data shows a change of +0.60 letters at 6 months and +1.50 letters at 12 months compared to baseline. No vision chart data was reported for the 18- or 24-month time points. It is important to note that this was a very small trial with only 7 participants, and the data was not reported for a comparison or control group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01660802 · results posted 8 June 2015
According to the results reported on ClinicalTrials.gov, this trial (NCT01660802) enrolled 262 people in total — 130 in the group that received a 700 μg dexamethasone treatment and 132 in a "sham" (inactive/control) group. The trial was measuring changes in vision in the treated eye, specifically using a standard eye chart where a higher number of letters read correctly means better vision. The main thing researchers were looking at was how many participants could read at least 15 more letters on the eye chart than they could at the start of the trial. The reported data shows that, for the primary measure, 60 out of 130 participants in the dexamethasone group and 31 out of 132 participants in the sham group reached that milestone of reading at least 15 more letters correctly. For the secondary measures, the reported data shows that both groups started with similar vision scores (around 52–53 letters on average). The dexamethasone group's average vision score across all study visits was reported as 6.6 letters higher than at the start, compared with 2.5 letters higher for the sham group. When looking at specific time points across the study, the percentage of participants in the dexamethasone group who gained 15 or more letters ranged from about 23% to 35% at different points, while in the sham group this ranged from about 5% to 22%, with the two groups appearing closer together at later time points. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00770770 · results posted 28 May 2015
According to the results reported on ClinicalTrials.gov, this trial looked at two different doses of a medicine called fluocinolone acetonide — a lower dose (0.2 µg per day) and a higher dose (0.5 µg per day) — in people with swelling at the back of the eye (macular oedema) caused by a blocked vein in the retina. A total of 20 people took part: 14 in the lower-dose group and 6 in the higher-dose group. The main thing being measured was how well participants could see after 3 months, compared to when they started, using a standard eye chart test that counts how many letters a person can read correctly. The reported data shows that, at the start of the study, participants in the lower-dose group could read an average of 47.0 letters on the eye chart, while those in the higher-dose group could read an average of 53.5 letters. After 3 months, the reported average change from the starting point was 7.0 letters in the lower-dose group and 9.2 letters in the higher-dose group, meaning participants in both groups were reading more letters on average than when they began. It is worth noting that a large number of participants — 10 out of 14 in the lower-dose group and 1 out of 6 in the higher-dose group — did not complete the study, which is important context when considering these figures. No secondary outcome data was reported in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT02181530 · results posted 25 May 2015
According to the results reported on ClinicalTrials.gov, this trial enrolled 43 participants, all of whom completed the study — none dropped out. Every participant received a treatment called OZURDEX®, which is a small implant placed in the eye. The trial was measuring changes in vision (specifically how many lines participants could read on a standard eye chart) and changes in the thickness of the retina (the light-sensitive layer at the back of the eye), before and after receiving the implant. The reported data shows that, for the main outcome — vision measured on a decimal eye chart scale (where 1.0 represents "normal" 20/20 vision) — the starting score was 0.22, and a change of 0.18 units was recorded over the course of the study. For the additional outcomes, 63% of participants were reported to have improved by 2 or more lines on the eye chart, and 53% improved by 3 or more lines. In terms of how quickly those changes were recorded, the reported data shows that a 2-line improvement was first noted at an average of around 105 days, and a 3-line improvement at around 100 days. Regarding retinal thickness (measured in micrometres, or μm — a very small unit of length), the starting average thickness was reported as 695.12 μm, with a reported change of −355.08 μm, meaning the retina was measured as thinner at the end of the study (a decrease in thickness was considered an improvement in this context). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01304706 · results posted 4 May 2015
According to the results reported on ClinicalTrials.gov, this trial enrolled 121 participants, all of whom received a treatment called fluocinolone acetonide. Of those, 104 people completed the trial, while 17 did not finish. The trial had one registered group, meaning there was no separate comparison or placebo group reported in this data. The main thing the trial set out to measure was how many participants experienced adverse events — that is, any unwanted or unexpected health occurrences — during the course of the study, including both general adverse events and serious adverse events. The reported data shows that out of 121 participants, 100 experienced at least one adverse event during the trial. The data also reports a figure of 42 participants in connection with serious adverse events, though the way the two figures are presented in the submitted results means they appear as separate measurements within the same outcome. No other outcome measures — such as measures of how well the treatment performed — were included in the results data submitted to ClinicalTrials.gov for this trial. It is worth noting that adverse event reporting in clinical trials captures any health occurrence during the study period, and a reported event is not necessarily caused by the treatment being studied. No secondary outcome measure results were reported in the data available. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01363440 · results posted 20 April 2015
According to the results reported on ClinicalTrials.gov, this trial enrolled 466 people in total across three groups: 156 received a laser treatment to the eye (the control group), 156 received injections of a medicine called aflibercept (EYLEA®) every four weeks, and 154 received the same injections every eight weeks. The trial was primarily measuring changes in vision — specifically, how many letters participants could correctly read on a standardised eye chart — over 52 weeks. Around 133–146 people in each group completed the full study period. The reported data shows that, at 52 weeks, the control (laser) group could read an average of 0.10 more letters than at the start — essentially no change. The group receiving injections every four weeks gained an average of 12.3 letters, and the group receiving injections every eight weeks gained an average of 10.6 letters. For the secondary measures, the reported data shows that 30% of the laser group gained at least 10 letters, compared with 100% in the four-weekly injection group and 88% in the eight-weekly injection group. Gaining at least 15 letters was reported for 12% of the laser group, 64% of the four-weekly group, and 47% of the eight-weekly group. The reported data also shows changes in retinal thickness (the central part of the retina) measured in microns: the laser group had an average reduction of 73.3 microns, while both injection groups had reductions of around 184–187 microns. A self-reported quality-of-life score specifically about close-up tasks (like reading) showed average improvements of 3.7 points for the laser group, 8.9 points for the four-weekly injection group, and 8.1 points for the eight-weekly injection group, on a scale of 0 to 100. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01790685 · results posted 3 April 2015
According to the results reported on ClinicalTrials.gov, this trial (NCT01790685) enrolled 40 people in total — 23 with central retinal vein occlusion (CRVO, a blockage in the main blood vessel draining the retina) and 17 with branch retinal vein occlusion (BRVO, a blockage in a smaller branch of that vessel). All 40 participants completed the study with no drop-outs recorded. The trial was looking at what happened to the levels of certain proteins in the fluid at the front of the eye — specifically proteins linked to fluid leakage in the retina, including VEGF, SDF-1, and Angiopoietin-2 — four weeks after receiving an injection of a medication called Ozurdex (a steroid implant placed in the eye). The reported data shows the primary outcome was the number of participants whose levels of these proteins fell by more than 30% at the four-week mark. Across the various proteins measured, the reported numbers of participants showing this degree of decrease ranged from 4 to 7 out of 23 in the CRVO group, and from 4 to 6 out of 17 in the BRVO group. The data as submitted does not label each individual measurement to a specific named protein, so a precise protein-by-protein breakdown cannot be provided beyond what the figures above reflect. No secondary outcome measure data was included in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01492400 · results posted 29 January 2015
According to the results reported on ClinicalTrials.gov, this trial enrolled 363 people in total — 181 in the dexamethasone intravitreal implant group and 182 in the ranibizumab group. Of those, 165 and 166 participants respectively completed the study. The trial was measuring changes in vision and eye health over time in people with a condition affecting the retina. The main thing being tracked was how well participants could read letters on an eye chart (known as Best Corrected Visual Acuity, or BCVA — essentially a standard measure of sharpness of vision). Two additional measurements were also taken: the thickness of a central part of the retina called the fovea, and the amount of fluid leaking from blood vessels in the back of the eye. The reported data shows that at the start of the study, both groups had similar average vision scores — around 60 letters read correctly out of 100. Over the course of the trial, the dexamethasone group's average vision score improved by about 4.3 letters, while the ranibizumab group's average score improved by about 7.6 letters. For foveal (retinal) thickness, both groups started at similar levels (around 465–471 microns, where a micron is a very tiny unit of measurement). The reported data shows the dexamethasone group had an average reduction of about 174 microns, and the ranibizumab group had an average reduction of about 164 microns — in both cases a reduction means the retina became thinner, which is the desired direction. For leakage from blood vessels in the eye, the dexamethasone group showed an average reduction of about 16.1 square millimetres and the ranibizumab group showed an average reduction of about 12.0 square millimetres, with reductions again indicating improvement. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01309451 · results posted 29 October 2014
According to the results reported on ClinicalTrials.gov, this trial (NCT01309451) enrolled 40 people in total — 19 in a group receiving bevacizumab (an eye injection medicine) alone, and 21 in a "Combined Group" receiving an additional treatment alongside bevacizumab. The trial was measuring two things at the 12-month mark: changes in vision sharpness (how many letters participants could read on a standardised eye chart, scored from 0 to 97 where higher is better), and changes in the thickness of a specific layer at the back of the eye, measured using a scanning technology called OCT. By the end of the study, 17 people in the bevacizumab-alone group and 18 in the combined group had completed the trial. The reported data shows that, on average, participants in the bevacizumab-alone group gained approximately 4.9 letters on the eye chart from their starting score, while those in the combined group gained approximately 5.4 letters. Regarding eye thickness, the reported data shows an average reduction of around 30 microns (a unit of measurement, roughly one-thousandth of a millimetre) in the bevacizumab-alone group, and around 45 microns in the combined group. No other outcome data appears to have been reported in the structured results submitted to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01135914 · results posted 23 October 2014
According to the results reported on ClinicalTrials.gov, this trial (NCT01135914) enrolled a total of 239 people across three groups: 78 received a combination therapy (ranibizumab injections plus laser treatment), 80 received ranibizumab injections alone, and 81 received laser treatment alone. The trial was measuring changes in vision sharpness (how many letters participants could read on a standardised eye chart) and changes in the thickness of the central part of the retina (the light-sensitive layer at the back of the eye) over 12 months. A self-reported quality-of-life questionnaire about visual functioning was also collected. The reported data shows that, at the 12-month mark, the average number of extra letters participants could read on the eye chart — compared to where they started — was 8.2 letters for the combination therapy group, 8.9 letters for the ranibizumab-only group, and 0.3 letters for the laser-only group. For retinal thickness (measured in micrometres), all three groups started with similar readings (roughly 422–458 µm on average). By month 12, the reported average change from the starting point was a reduction of 138.1 µm in the combination group, 135.9 µm in the ranibizumab-only group, and 85.8 µm in the laser-only group. Regarding a larger vision gain — specifically gaining 15 or more letters on the chart by month 12 — the reported data shows this was recorded in 24.3% of the combination group, 21.1% of the ranibizumab-only group, and 6.5% of the laser-only group. The quality-of-life questionnaire (scored from 0 to 100, where 100 is the best outcome) showed average composite scores at 12 months of 85.21, 84.29, and 78.20 for the combination, ranibizumab-only, and laser-only groups respectively. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01247220 · results posted 6 October 2014
According to the results reported on ClinicalTrials.gov, this trial enrolled 12 people in total, split into two groups of 6. One group received a combination of peripheral laser treatment plus a medicine called ranibizumab (a drug injected into the eye), while the other group received ranibizumab alone. All 12 participants completed the study. The trial was measuring vision, the thickness of a part of the eye called the retina, and how many injections of ranibizumab each group needed over the second half of the observation period. The reported data shows that vision was measured using a standard eye chart test called an ETDRS chart, where a higher number of letters read correctly indicates better vision. The combination group scored an average of 16.8 letters at one time point and 19.1 letters at another, while the ranibizumab-only group scored 14.5 letters and 15.3 letters at the corresponding time points. For retinal thickness (measured in microns, a very small unit of length), the reported data shows the combination group measured 207 microns at one point and 282 microns at another, compared to 241 microns and 281 microns for the ranibizumab-only group. Regarding injections needed in the second six months, the combination group averaged 0.06 injections per person, while the ranibizumab-only group averaged 2.2 injections per person. It is worth noting that with only 6 people in each group, this was a very small trial, and the data should be interpreted with that in mind. The results as reported do not include all the additional detail that would be needed to draw broader conclusions, and some contextual information was not reported in the structured data provided. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01171976 · results posted 15 September 2014
According to the results reported on ClinicalTrials.gov, this trial (NCT01171976) enrolled 372 people across three groups, all of whom received the eye medicine ranibizumab (0.5 mg) in different ways: one group received ranibizumab combined with laser treatment, one group received ranibizumab alone on a "treat and extend" schedule (meaning injections were given and then spaced out over time based on how the eye was responding), and one group received ranibizumab only when needed (called "PRN" — as required). The trial was measuring changes in vision over two years, using a standard letter-reading eye chart. Around 107 to 117 people in each group completed the full study period. The reported data shows that vision scores — measured in letters read correctly on an eye chart — improved across all three groups over the course of the trial. At the start, average scores ranged from about 62 to 65 letters across the groups. By 12 months, the reported average change from the starting score was approximately +5.9 letters for the ranibizumab-plus-laser group, +6.1 letters for the ranibizumab-alone treat-and-extend group, and +6.2 letters for the as-needed group. By 24 months, the reported changes were approximately +8.3, +6.5, and +8.1 letters respectively. At the 24-month mark, the reported data also shows that roughly 84–91% of participants across all groups had not lost more than a small number of letters compared to where they started, though the exact breakdown varied by group and threshold measured. The reported data shows similar patterns when looking at specific time points (month 12 and month 24 individually), with all three groups showing modest gains in the number of letters read on average. The data as submitted does not allow a direct conclusion about which approach produced better or worse results — only the numbers themselves are reported here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00406107 · results posted 12 September 2014
According to the results reported on ClinicalTrials.gov, this trial involved 20 people in total — 15 received a 0.3 mg dose of pegaptanib sodium (Macugen) and 5 received a 1 mg dose. The trial was looking at changes in vision and changes in the thickness of a part of the eye called the macula (the central area of the retina responsible for detailed vision) over 54 weeks. Of the 20 who started, 18 completed the study — 14 in the lower-dose group and 4 in the higher-dose group. The reported data shows that, looking at all participants together, vision (measured using a standard eye chart test called ETDRS, which counts the number of letters a person can read) changed by an average of 14 letters from the start of the trial to week 54. For the macula thickness measurements — taken using a scanning eye test called OCT — the reported data shows an average reduction of around 201 to 205 microns (a micron is a very tiny unit of measurement) depending on which specific measurement was used, suggesting the macula appeared thinner at week 54 compared to the start. The overall volume of the macula also showed a reported average reduction of 2.2 cubic millimetres across all participants. Regarding a safety-related measure, the reported data shows that 6.67% of participants in the 0.3 mg group and 0% in the 1 mg group had investigator-reported side effects (both eye-related and general health-related events were tracked, rated from mild to severe). It is important to note this was a small study with only 20 participants, and the data as reported does not allow conclusions to be drawn about how broadly these numbers might apply. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01331681 · results posted 9 September 2014
According to the results reported on ClinicalTrials.gov, this trial enrolled 406 adults across three groups: 136 received intravitreal aflibercept injections every four weeks (2Q4), 135 received them every eight weeks (2Q8), and 135 received macular laser treatment, which was the control group. The trial was measuring changes in vision in people with a condition affecting the central part of the retina (diabetic macular oedema). The main thing being tracked was how much participants' vision — measured by the number of letters they could correctly read on a standardised eye chart — changed after 52 weeks compared to where they started. The reported data shows that, on average, participants in the two injection groups gained around 10.5 and 10.7 letters on the eye chart respectively, while the laser control group gained an average of 1.2 letters. When looking at bigger improvements, the reported data shows that roughly 54% of the first injection group and 53% of the second injection group gained at least 10 letters, compared with about 26% in the laser group. For a gain of at least 15 letters, the figures were approximately 32%, 33%, and 9% respectively. The reported data also shows changes in the thickness of the central retina (measured by a scan called OCT): the two injection groups showed an average reduction of around 195 and 192 micrometres, while the laser group showed an average reduction of about 66 micrometres. A patient questionnaire about near-vision tasks (such as reading a newspaper) also showed score changes of roughly 5.7 and 5.3 points in the injection groups and 3.5 points in the laser group, on a scale of 0 to 100. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00168337 · results posted 4 August 2014
According to the results reported on ClinicalTrials.gov, this trial enrolled 554 people across three groups: 188 received a higher-dose dexamethasone implant (700 micrograms), 181 received a lower-dose implant (350 micrograms), and 185 received a sham (dummy) procedure. The trial was measuring changes in vision in the treated eye, specifically using a standard eye-chart test where a higher number of letters read correctly means better vision. The study also looked at the thickness of the retina (the light-sensitive layer at the back of the eye) using a scanning technology called OCT. The reported data shows that for the main (primary) outcome — the proportion of people whose vision improved by 15 or more letters on the eye chart — 22.3% of the higher-dose group, 18.2% of the lower-dose group, and 10.8% of the sham group reached that level of improvement. For a smaller improvement of 10 or more letters, the reported figures were 34.6%, 29.8%, and 24.9% respectively. Looking at the average change in letters read across all study visits, the higher-dose group went from about 55.9 letters to a change of roughly +2.9 letters, the lower-dose group similarly went from 55.2 to +2.9 letters, and the sham group went from 57.0 letters to +2.0 letters. At the final study visit specifically, the reported changes were +1.3 letters, +1.4 letters, and approximately 0.0 letters. For retinal thickness, the reported average reductions were about 117.9 microns in the higher-dose group, 131.2 microns in the lower-dose group, and 70.4 microns in the sham group (where a reduction represents a decrease in swelling). An additional analysis reported that the first 10% of participants to reach a 15-letter improvement did so at around 50 days in the higher-dose group, 49 days in the lower-dose group, and 186 days in the sham group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00464685 · results posted 4 August 2014
According to the results reported on ClinicalTrials.gov, this trial enrolled 253 people in total — 126 received a dexamethasone implant (a small drug-releasing device placed in the eye) combined with laser treatment, while 127 received a sham (dummy) implant combined with laser treatment. The trial was measuring changes in vision and eye health over time, particularly whether people's ability to read letters on an eye chart improved, and whether swelling and fluid leakage at the back of the eye changed. The reported data shows that for the main outcome — the proportion of people who could read at least 10 more letters on the eye chart compared to when they started — 27.8% of those in the dexamethasone implant group reached this threshold, compared with 23.6% in the sham group. For the secondary outcomes, the average number of letters read correctly changed by about 2.9 letters (improvement) in the dexamethasone group and 2.1 letters in the sham group, starting from similar baselines of around 57–58 letters. Retinal thickness (swelling at the back of the eye, measured in microns) decreased by an average of 102.8 microns in the dexamethasone group and 125.3 microns in the sham group. The area of fluid leakage decreased by 0.2 units in the dexamethasone group and 0.7 units in the sham group. The average time before participants needed retreatment was 189 days in the dexamethasone group and 196 days in the sham group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00799227 · results posted 4 August 2014
According to the results reported on ClinicalTrials.gov, this trial involved 56 participants, all of whom received a 700 micrograms dexamethasone implant (a small, slow-release drug insert placed in the eye). The study was measuring changes in the thickness of the central part of the retina (the light-sensitive layer at the back of the eye) as its main goal, and also looked at changes in vision and signs of fluid leakage in the eye. Of the 56 people who started, 53 completed the trial. The reported data shows that, on average, participants started with a central retinal thickness of about 403 microns. By the end of the study, that average had decreased by roughly 39 microns — and as noted in the trial's own description, a decrease in thickness represents an improvement in this measure. For vision, participants started out reading an average of about 54.5 letters correctly on an eye chart, and that figure increased by an average of 3 letters over the course of the study. Around 21% of participants read at least 10 more letters correctly at the end compared to the start. Regarding fluid leakage in the eye (measured using a dye-based imaging technique), the reported data shows that approximately 33% of participants showed an improvement in leakage, 57% showed no meaningful change, and around 10% showed a worsening. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00168389 · results posted 4 August 2014
According to the results reported on ClinicalTrials.gov, this trial involved 494 people across three groups: 163 received a higher-dose dexamethasone implant (700 micrograms), 166 received a lower-dose implant (350 micrograms), and 165 received a sham (dummy) procedure. The trial was measuring changes in vision in the treated eye, specifically looking at how many letters participants could read correctly on an eye chart, as well as changes in the thickness of the retina (the light-sensitive layer at the back of the eye). Not everyone completed the study — 107, 118, and 70 participants finished in each group respectively. The reported data shows that the main outcome — the percentage of participants whose vision improved by 15 or more letters on the eye chart — was 22.1% in the higher-dose group, 18.7% in the lower-dose group, and 13.3% in the sham group. For a smaller improvement of 10 or more letters, the reported figures were 38.7%, 34.3%, and 23.0% respectively. When looking at the average change in letters read across all study visits, the reported data shows increases of around 4.1 letters (higher dose), 4.3 letters (lower dose), and 1.9 letters (sham) from a starting point of roughly 56 letters in all three groups. The reported data also shows that retinal thickness decreased on average by about 101 microns (higher dose) and 104 microns (lower dose), compared with about 38 microns in the sham group — where a decrease means the retina became less swollen. The reported data also shows that among the first 10% of participants to reach a 15-letter vision improvement, this happened at around 50 days in the higher-dose group, 51 days in the lower-dose group, and 150 days in the sham group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01396057 · results posted 16 July 2014
According to the results reported on ClinicalTrials.gov, this trial (NCT01396057) compared two treatments for an eye condition — an injection called ranibizumab and a steroid implant called dexamethasone. A total of 244 people started the trial (126 in the ranibizumab group and 118 in the dexamethasone group), and 215 completed it (115 and 100 respectively). The trial's main measure was how much participants' best corrected vision — that is, vision when wearing the best possible glasses or contact lenses — changed over the first six months of treatment, measured by how many letters a person could read on a standard eye chart. The reported data shows that, on the primary measure, the ranibizumab group gained an average of 14.9 letters on the eye chart over the six months, while the dexamethasone group gained an average of 10.1 letters. A related secondary measure using a slightly different calculation reported gains of 16.18 letters for ranibizumab and 8.10 letters for dexamethasone. The reported data also shows that, at the six-month mark, 77 participants in the ranibizumab group and 44 in the dexamethasone group gained 15 or more letters. Regarding the time it took for a person to first gain 15 or more letters, both groups reached that point at around 63–64 days on average. For a measure of retinal (the light-sensitive layer at the back of the eye) thickness, the ranibizumab group showed an average reduction of 230.6 micrometres compared with a reduction of 112.3 micrometres in the dexamethasone group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00901186 · results posted 3 July 2014
According to the results reported on ClinicalTrials.gov, this trial compared two treatments for an eye condition: a medicine called RFB002 (ranibizumab 0.5 mg, given as an injection into the eye) and laser photocoagulation (a laser-based procedure). A total of 40 people were enrolled in the RFB002 group and 43 in the laser group at the start. By the end of the study, 31 people in the RFB002 group and 32 in the laser group had completed it. The trial's main goal was to measure changes in participants' best corrected visual acuity — that is, how many letters on a standard eye chart people could read with the best possible glasses correction. The reported data shows that, on average, participants in the RFB002 group gained approximately 9.4 letters on the eye chart from where they started, while those in the laser group gained approximately 5.8 letters. For a secondary measure looking at the proportion of people whose vision improved, about 74% of the RFB002 group and about 68% of the laser group showed some improvement. The reported data also shows that about 54% of the RFB002 group reached a vision score above 73 letters (roughly the level considered good vision on this type of chart), compared with about 24% in the laser group. Measurements of central retinal thickness — the thickness of the central part of the retina at the back of the eye, measured by a scanning technique — showed reductions in both groups across all study visits, with larger reductions recorded in the RFB002 group at each time point. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00952614 · results posted 30 June 2014
According to the results reported on ClinicalTrials.gov, this trial enrolled 30 people, all of whom received a treatment called Retisert (a small implant that slowly releases a steroid medication into the eye) for a condition called retinal vein occlusion — a blockage of a blood vessel in the eye that can affect vision. The trial was measuring two main things: changes in how well participants could read letters on a standard eye chart (called an ETDRS chart), and changes in swelling at the back of the eye (a condition called macular oedema). Of the 30 people who started, 23 completed the trial, and 7 did not finish. The reported data shows that, when looking at the primary measure — how many letters participants could read correctly on the eye chart — the results at three different time points during the study were 12.5 letters, 14 letters, and 13.5 letters of change from their starting point. The data does not specify exactly which time points these measurements correspond to. For the secondary measure, the reported data shows a change of 10.4 mm³ in what is called Total Macular Volume — a way of calculating the amount of retinal swelling using a special eye scan — though the direction of that change (increase or decrease) is not explicitly stated in the submitted data. It is worth noting that this was a single-group study with no comparison group, and the reported figures describe what was measured rather than confirming any particular outcome for the treatment. Some details, such as the specific time points for the vision measurements, were not fully reported in the data submitted to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00779142 · results posted 30 June 2014
According to the results reported on ClinicalTrials.gov, this trial involved 5 people, all of whom received injections of methotrexate (at a concentration of 25mg/ml) directly into the eye. The trial was looking at whether this treatment could reduce swelling in a specific part of the eye called the macula — the area responsible for detailed, central vision. Of the 5 people who started the trial, only 2 completed it, and 3 did not finish. The reasons for not completing were not reported in the data provided. The reported data shows the following numbers for the outcomes measured. For the main (primary) outcome — whether a particular layer of the eye (measured using a scanning technology called OCT, which produces detailed cross-section images) showed at least a 30% reduction in thickness four weeks after the last injection — 2 out of the 5 participants met this measure. For the first secondary outcome — whether a participant's vision improved by two lines or more on an eye chart one month after the last injection — 1 participant was reported to have met this measure. For the second secondary outcome — whether there was a notable clinical improvement in the macular swelling as assessed by a doctor using a specialised eye examination — 1 participant was also reported to have met this measure. It is worth noting that this was a very small trial with only 5 participants, and the data as submitted does not include further detail about why 3 participants did not complete the study. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01027650 · results posted 29 April 2014
According to the results reported on ClinicalTrials.gov, this trial enrolled 121 participants in total across eight groups. It was run in two stages. Stage 1 had four smaller groups (called cohorts) of 3 to 6 people each, while Stage 2 had four larger groups (called arms) of 24 to 26 people each. The trial was measuring two things in the treated eye: the thickness of the retina (the light-sensitive layer at the back of the eye), scanned using a specialised laser imaging tool; and vision sharpness, measured by how many letters a person could read correctly on an eye chart (out of a possible 100 letters). Both measurements were taken at the start of the trial and again after one month and twelve months, to see how much they changed. The reported data shows the following for retinal thickness (measured in microns, a unit of length — a smaller number means a thinner, less swollen retina). In Stage 1, starting retinal thickness across the four cohorts ranged from about 468 to 500 microns on average. After one month, the reported average change ranged from around −207 to −256 microns (a negative number meaning the retina became thinner). At twelve months, the reported average change ranged from about −168 to −240 microns. In Stage 2, starting retinal thickness ranged from about 598 to 680 microns on average across the four arms. After one month, the reported average change ranged from about −299 to −317 microns, and at twelve months, it ranged from about −169 to −253 microns. For vision sharpness, in Stage 1 participants started by reading roughly 50 to 60 letters on average, and after one month the reported average increase ranged from about 9 to 12 letters across the cohorts. In Stage 2, starting scores ranged from about 48 to 58 letters, and after one month the reported average increase ranged from about 11 to 14 letters across the arms. Twelve-month vision figures were not reported in the data submitted. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01277302 · results posted 23 April 2014
According to the results reported on ClinicalTrials.gov, this trial (NCT01277302) involved 202 people in total. Of these, 85 were randomly assigned to receive monthly injections of ranibizumab 0.5 mg, 86 were randomly assigned to receive injections on an as-needed basis (called "PRN"), and a further 31 people were enrolled in a separate non-randomised group receiving monthly injections. The trial was measuring changes in vision — specifically, how many letters participants could read correctly on a standard eye chart — over a 15-month period. The study looked at whether there was any difference in vision score trends between the monthly and as-needed injection groups during the later part of the trial (months 7 to 15). The reported data shows that, as a primary finding, both the monthly and as-needed groups had higher letter scores at months 7 and 15 compared to where they started. The monthly group's reported average change from their starting scores was 17.5 letters at month 7 and 18.7 letters at month 15, while the as-needed group showed average changes of 19.7 letters at month 7 and 21.0 letters at month 15. For the secondary measures, the reported data shows that around 62–67% of the monthly group and 67–71% of the as-needed group gained 15 or more letters from their starting score (a commonly used milestone in eye research), compared to around 41–46% in the non-randomised group. Approximately 72–73% of the monthly group, 77% of the as-needed group, and around 46–47% of the non-randomised group were reported to reach a vision level equivalent to 20/40 or better on a standard eye chart. Nearly all participants across all groups — reported at 98.8% to 100% — avoided losing 15 or more letters from their starting score. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01640171 · results posted 21 April 2014
According to the results reported on ClinicalTrials.gov, this trial enrolled 57 participants, and all 57 completed the study with no dropouts. Each participant received two different types of numbing (anaesthetic) for eye injections — one type applied as eye drops directly onto the eye's surface (called topical anaesthesia), and another type given as a small injection under the white part of the eye (called subconjunctival anaesthesia) — with each method used on a different eye. The trial was measuring which method participants preferred, and how much pain they reported with each. The reported data shows that at the final follow-up visit, 50 out of 57 participants indicated they preferred the subconjunctival (under-the-eye) method. For pain levels, the trial used a standard 0–10 pain rating scale (where 0 means no pain and 10 means the worst possible pain). The reported data shows that zero participants rated their pain as 10 out of 10 in the eye that received the subconjunctival anaesthetic at the time of the injection. Additionally, when participants were asked to compare the two eyes directly, 19 out of 57 said the eye treated with the surface drops hurt "much more" than the eye that received the subconjunctival injection. It is worth noting that some figures — such as average pain scores across all participants or results broken down by visit — were not reported in the data submitted to ClinicalTrials.gov, so those details cannot be described here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01085734 · results posted 21 April 2014
According to the results reported on ClinicalTrials.gov, this trial involved 30 people in total, split into two groups of 15. The trial was looking at an eye condition affecting the macula (the central part of the retina responsible for detailed vision). It measured three things: how well participants could see after six months, how many injections they needed during the study, and changes in the thickness of the macula (a layer at the back of the eye), which was measured using a scanning technology called OCT. The reported data shows that, when it came to vision — measured using a letter-reading chart called the ETDRS scale, where higher scores mean better vision — Group 1 showed an average change of +2.3 letters from their starting point, while Group 2 showed an average change of +0.1 letters. For the number of injections needed over the course of the study, the reported data shows Group 1 received a total of 14 injections and Group 2 received 11 injections. Regarding macular thickness (measured in microns, which are very small units of length), Group 1 showed an average increase of 45.4 microns from baseline, while Group 2 showed an average decrease of 55.6 microns. It is worth noting that not all participants completed the study — one person in Group 1 and four people in Group 2 did not finish. The reported data does not include information explaining which specific treatment each group received, so direct comparisons between groups cannot be fully contextualised from this data alone. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00490815 · results posted 13 February 2014
According to the results reported on ClinicalTrials.gov, this trial involved 37 people in total — 20 received a small implant designed to release 0.2 micrograms of a medicine called fluocinolone acetonide per day, and 17 received a higher-dose implant releasing 0.5 micrograms per day. The trial was measuring how much of the medicine from these implants entered the bloodstream and the fluid inside the eye (called aqueous humor), and also looked at the thickness of the retina (the light-sensitive layer at the back of the eye). Not everyone finished the study — 12 people in the lower-dose group and 8 in the higher-dose group completed it. The reported data shows that the main thing being measured was the average level of the medicine detected in the blood and eye fluid, recorded in very small units called picograms per millilitre. For the lower-dose (0.2 microgram) implant group, the average level recorded was approximately 1.49 pg/ml, while for the higher-dose (0.5 microgram) implant group it was approximately 0.71 pg/ml. For the secondary measurement — retinal thickness — the reported data shows an average of 343.8 units for the lower-dose group and 324.2 units for the higher-dose group. It is worth noting that the unit listed for retinal thickness in the submitted data was "µg," which appears to be an error in the submission, as retinal thickness is typically measured in micrometres; the data as submitted has not been altered here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01198327 · results posted 13 January 2014
According to the results reported on ClinicalTrials.gov, this trial enrolled 66 people who received the eye injection medicine ranibizumab on an "as needed" basis — meaning they received injections when their treating doctor felt it was necessary, rather than on a fixed schedule. The participants had either central retinal vein occlusion (CRVO) or branch retinal vein occlusion (BRVO), which are conditions affecting blood flow in the eye. Of the 66 who started, 56 completed the study and 10 did not. The trial was primarily measuring how often serious unwanted medical events occurred, and also tracked changes in vision and retinal (the light-sensitive layer at the back of the eye) thickness over time. The reported data shows that across all 66 participants, a total of 17 serious adverse events (serious unwanted medical occurrences) were recorded during the study period. For the vision measurements, the trial used a standard eye chart scoring system where higher scores mean better vision (on a scale of 0 to 100). The reported data shows that participants in the CRVO group had an average improvement of 14.0 letters on this scale, while those in the BRVO group had an average improvement of 20.1 letters. Regarding retinal thickness — measured in microns (tiny units of length) using a specialised eye scan — the CRVO group showed an average reduction of 426.0 microns, and the BRVO group showed an average reduction of 236.2 microns. Whether these changes are meaningful in a clinical sense is not something this summary can determine. It is worth noting that this was a single-group study with no comparison group, and the results reflect averages across the participants in each subgroup. Individual results among participants would have varied. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01189461 · results posted 6 September 2013
According to the results reported on ClinicalTrials.gov, this trial involved 46 people, all of whom received a treatment called Macugen (pegaptanib), which is given as an injection into the eye. The trial was looking at two main things: how many people experienced unwanted medical events (called adverse events) during the study, and how many injections participants received on average. A secondary focus was whether participants' vision changed over the course of the study. Of the 46 people who started, only 12 completed the trial, and 34 did not finish. The reported data shows that, for the primary outcomes, 10 participants experienced unwanted medical events related to the eye, and 8 experienced unwanted medical events in other parts of the body. On average, participants received approximately 3.24 injections over the course of the study. For the secondary outcomes, the reported data shows that no participants experienced serious eye-related medical events (defined as events leading to hospitalisation, life-threatening situations, lasting disability, or death), while 3 participants experienced serious medical events elsewhere in the body. Regarding vision, participants' scores on a standard vision test (where 0 represents very poor vision and 78 represents the best possible score) started at an average of 58.93, and by week 48 the average change from that starting point was reported as 2.21 units — though the direction of that change (improvement or decline) was not clearly specified in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01566526 · results posted 27 May 2013
According to the results reported on ClinicalTrials.gov, this trial enrolled 26 participants who had previously received a treatment called OZURDEX® (a slow-release steroid implant injected into the eye) for a condition affecting the retina. All 26 participants completed the study. The main thing the trial was measuring was how long it took before participants needed a second injection of OZURDEX® after their first one. The trial also tracked changes in vision sharpness (measured by how many letters a person could read on a special eye chart) and changes in the thickness of the retina (the light-sensitive layer at the back of the eye), as well as how quickly vision improvements occurred. The reported data shows that, on average, the time between the first and second OZURDEX® injection was about 144 days (roughly 4.7 months). For vision sharpness, the average score at the starting point (baseline) before the last injection was about 62 letters read correctly, and in the 7 to 12 weeks after the last injection, participants' scores had changed by an average of minus 5 letters compared to that baseline. For retinal thickness, the starting measurement averaged 665 micrometres (a very small unit of length), and by 7 to 12 weeks after the last injection, the average change was a reduction of about 382 micrometres. The reported data also shows that 50% of participants had an improvement of at least 2 lines on the eye chart after the first injection, and 42.3% showed an improvement of at least 3 lines. On average, a 2-line improvement in vision was first recorded at around 41 days after the first injection. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01614509 · results posted 4 December 2012
According to the results reported on ClinicalTrials.gov, this trial enrolled 45 people in total — 24 in a group receiving a single treatment (called the Monotherapy Group) and 21 in a group receiving a combination of two treatments (the Combined Group). The trial was measuring changes in the thickness of the central part of the retina (the light-sensitive layer at the back of the eye) over six months, using a scanning device called OCT. It also tracked how many additional injections of a medicine called bevacizumab each group needed during that period. The reported data shows that, at the start of the trial, the average central retinal thickness was around 510 micrometres (a micrometre is one-thousandth of a millimetre) in the Monotherapy Group and about 468 micrometres in the Combined Group. By the one-month mark, those figures had dropped to approximately 291 and 233 micrometres respectively. At three months, the readings were roughly 265 and 233 micrometres, and by six months they were around 246 and 218 micrometres for the Monotherapy and Combined groups respectively. The reported data also shows that, over the six months, participants in the Monotherapy Group received an average of about 0.96 additional injections, while those in the Combined Group received an average of about 0.44 additional injections. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01012973 · results posted 22 November 2012
According to the results reported on ClinicalTrials.gov, this trial enrolled 177 people in total — 106 in the group that received aflibercept injections (also known as EYLEA) from the start, and 71 in the group that initially received a sham (dummy) treatment before later switching to aflibercept injections. The trial was looking at a condition affecting vision, and the main thing it set out to measure was whether participants gained a meaningful amount of vision — specifically, whether they could read at least 15 more letters on a standard eye chart after 24 weeks, compared to where they started. The reported data shows that, at the 24-week mark, around 60% of participants in the aflibercept group gained at least 15 extra letters on the eye chart, compared to about 22% in the sham treatment group. When looking at the average number of letters participants could read on the eye chart at week 24, the aflibercept group averaged around 71.6 letters correctly read, while the sham group averaged 54.3 letters. The reported data also shows that a measurement of fluid or swelling at the back of the eye (called central retinal thickness, measured in very small units called microns) decreased by an average of about 449 microns in the aflibercept group, compared to about 169 microns in the sham group. On a quality-of-life questionnaire specifically about vision (scored from 0 to 100, with higher being better), the aflibercept group showed an average improvement of 7.46 points from their starting score, while the sham group showed an average improvement of 3.55 points. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00989989 · results posted 18 October 2012
According to the results reported on ClinicalTrials.gov, this trial enrolled 396 people across three groups: 132 in the "Adjunctive Treatment" group (a combination approach), 133 in the "Monotherapy Treatment" group (a single treatment), and 131 in the "Laser Control" group. The trial ran for 12 months and was mainly measuring changes in vision sharpness — specifically how many letters participants could read on a standardised eye chart — as well as changes in the thickness and fluid levels of the retina (the light-sensitive layer at the back of the eye). The reported data shows that, on average, the Adjunctive Treatment group gained 5.7 letters of vision over 12 months, the Monotherapy group gained 5.9 letters, and the Laser Control group gained 1.4 letters, compared to where each group started. When retinal thickness was measured at 12 months, the Adjunctive Treatment group showed an average reduction of 171.8 micrometres, the Monotherapy group a reduction of 134.6 micrometres, and the Laser Control group a reduction of 57.2 micrometres (a reduction indicates a change from baseline). Regarding a larger vision gain — specifically gaining 10 or more letters from the starting point — the reported figures were 37.2% of participants in the Adjunctive group, 33.8% in the Monotherapy group, and 13.3% in the Laser Control group. At 12 months, 20.5%, 16.5%, and 8.5% of participants in those same groups respectively had vision above 73 letters on the chart. The reported data also includes measurements of fluid and cyst changes within the retina at the end of the study, though the breakdown across multiple sub-categories makes direct plain-English comparison difficult without further context from the study team. These figures were collected using a specialised retinal imaging technique and varied across all three groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01120899 · results posted 6 September 2012
According to the results reported on ClinicalTrials.gov, this trial looked at minocycline (an antibiotic tablet) in people with a specific eye condition. Six participants were enrolled in the single treatment group. The trial tracked them over time, measuring two main things: how well participants could read letters on a standardised eye chart (called an ETDRS chart, where more letters read means sharper vision), and how thick the retina — the light-sensitive layer at the back of the eye — was over time. By the end of the study, three participants had completed it, and three did not finish. The reported data shows that, compared to where participants started, the average number of additional letters read on the eye chart increased over time in the study eye: participants read about 5.8 more letters at 6 months, 8.0 more letters at 12 months, 9.0 more letters at 18 months, and 9.3 more letters at 24 months. The reported data also shows changes in retinal thickness: on average, thickness decreased by about 8.1% at 6 months and by about 12.35% at 12 months compared to the starting point. No primary outcome measure results were included in the data submitted to ClinicalTrials.gov, so those figures cannot be reported here. It is important to note that this was a very small trial with only six participants, which means these numbers should be interpreted with great caution. The reported data shows what was measured in this particular group — it does not on its own tell us what minocycline would do in a larger or different group of people. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01131585 · results posted 17 August 2012
According to the results reported on ClinicalTrials.gov, this trial (NCT01131585) involved 128 people in total — 85 in one group who received active laser photocoagulation combined with ranibizumab (an injection into the eye), and 43 in a second group who received active laser photocoagulation combined with a sham (dummy) injection. The trial's main goal was to measure any change in participants' best-corrected visual acuity — that is, how many letters on a standardised eye chart they could read when wearing their best possible glasses or contact lenses — after 12 months compared to when they started. The reported data shows that, on average, the group receiving ranibizumab alongside laser treatment gained 6.5 letters on the eye chart over 12 months, while the group receiving the sham injection alongside laser treatment gained an average of 1.4 letters over the same period. A higher number indicates that participants could read more letters at 12 months than they could at the start of the trial. It is worth noting that the completion data recorded in the trial registry shows zero participants listed as having formally "completed" the study in either group, and no explanation for this was provided in the submitted data. No secondary outcome measures were included in the data submitted to ClinicalTrials.gov for this trial, so no further results can be described here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00768040 · results posted 6 March 2012
According to the results reported on ClinicalTrials.gov, this trial enrolled 39 people with type 1 or type 2 diabetes — 20 received a drug called aliskiren (at a dose of 300 mg) and 19 received a placebo (a dummy treatment with no active ingredient). The trial ran for 12 weeks and was measuring whether there was any change in the thickness of a specific layer at the back of the eye called the central retinal thickness, which was assessed using a scanning technology called optical coherence tomography (a non-invasive imaging scan of the eye). The reported data shows that 16 participants in each group completed the study. Four people in the aliskiren group and three in the placebo group did not finish the trial, though the reasons were not detailed in the data provided here. Regarding the main thing the trial was set up to measure — the change in central retinal thickness from the start to the end of the 12 weeks — no numerical results appear to have been submitted in the structured data available on ClinicalTrials.gov. The figures for this outcome measure were not reported in the data provided, so it is not possible to describe what the numbers showed. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00379795 · results posted 13 January 2012
According to the results reported on ClinicalTrials.gov, this extension study enrolled 853 participants across five groups. The groups reflected different treatment histories from an earlier trial: some had received the eye injection medicine ranibizumab alone, some had received it combined with a light-based therapy called PDT, some had crossed over from a sham (dummy) treatment, some had crossed over from PDT alone, and one group had received no treatment. The trial was measuring how many participants experienced side effects (both in the eye and elsewhere in the body), whether the body produced immune responses to the medicine, and how participants' vision changed over time. Vision was measured by the number of letters a person could read on a standard eye chart. The reported data shows that when it came to eye-related side effects, the numbers ranged across the four treated groups: for example, in the largest group (those who had been on ranibizumab alone from the start), 418 out of 526 participants reported any eye-related side effect, 46 reported a serious eye-related side effect, and 7 stopped the study because of one. For side effects occurring elsewhere in the body, 427 participants in that same largest group reported any such event, 169 reported a serious one, and 27 left the study because of one. Regarding immune responses (the body making antibodies against the medicine), the reported data shows small numbers tested positive — for instance, 10 participants in the largest group at the 12-month mark and 9 at 24 months; the other groups showed very few or none. The reported data shows that, for vision (measured in letters read on an eye chart), most groups showed a small decline in the number of letters they could read compared to where they started at the beginning of the original trial. For example, across the total study population, the change at one timepoint was around minus 2.7 to minus 3.7 letters at the closer test distance, and around minus 4.4 to minus 5.7 letters at the further test distance — meaning on average participants were reading slightly fewer letters over time. The untreated group showed little change at some timepoints, though the data was not reported for all distances and timepoints. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01442064 · results posted 10 January 2012
According to the results reported on ClinicalTrials.gov, this extension trial (NCT01442064) followed on from two earlier studies (known as BRAVO and CRUISE) that had looked at a medicine called ranibizumab for people with vision problems caused by retinal vein occlusion — a blockage in a blood vessel at the back of the eye. A total of 608 people started the extension study across six groups, depending on which earlier study they had been in and what dose they had previously received (a sham/dummy injection, 0.3 mg, or 0.5 mg of ranibizumab). The trial tracked adverse events (unwanted health events that occurred during the study) in and around the eye, as well as changes in vision sharpness, retinal thickness, and self-reported visual quality of life over time. The reported data shows that, for unwanted events in the treated eye, between 51 and 67 participants per group experienced at least one such event, while between 0 and 2 participants per group had an event serious enough to stop treatment. For unwanted events elsewhere in the body, between 56 and 77 participants per group experienced at least one, and between 10 and 21 per group had a serious event. Regarding vision sharpness — measured by the number of letters read correctly on a standard eye chart — the reported data shows small negative changes from the starting point across all groups at both measurement time points (ranging from around −0.1 to −5.2 letters), meaning on average participants were reading slightly fewer letters than at baseline. For retinal thickness (a scan-based measure of swelling at the back of the eye), the reported changes from baseline were reductions in thickness across all groups (for example, reductions of 21.5 to 161.4 micrometres at the first time point), with smaller reductions recorded at the later time point. For the self-reported visual quality-of-life questionnaire (scored 0–100, where higher is better), changes from the starting point were small and mixed across groups; some figures for Month 24 were not reported in the data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00445003 · results posted 13 July 2011
According to the results reported on ClinicalTrials.gov, this trial enrolled 345 people across three groups to study treatments for diabetic macular oedema (swelling at the back of the eye related to diabetes). Participants were randomly assigned to receive either a sham (dummy) injection, an injection of a medicine called ranibizumab (0.5 mg), or an injection of a steroid called triamcinolone acetonide (4 mg). The main thing the trial was measuring was how much a person's vision — scored on a standardised letter-reading scale from 0 (worst) to 97 (best) — changed over 14 weeks. Most participants completed the study: 118 in the sham group, 103 in the ranibizumab group, and 105 in the triamcinolone group. The reported data shows that, on average, vision scores changed from the starting point by −4 letters in the sham group, +1 letter in the ranibizumab group, and +2 letters in the triamcinolone group at the 14-week mark. For a secondary measure looking at the thickness of the central part of the retina (the light-sensitive layer at the back of the eye), as measured by a scanning technique called optical coherence tomography, the reported average thickness figures were 362 microns in the sham group, 312 microns in the ranibizumab group, and 265 microns in the triamcinolone group. A separate longer-term vision score change from baseline was also reported: −6 letters for sham, −4 letters for ranibizumab, and −5 letters for triamcinolone. The trial also tracked the total volume of retinal tissue and how many eyes needed additional treatments during the study period, with the specific numbers varying across groups as reported in the data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00369486 · results posted 14 June 2011
According to the results reported on ClinicalTrials.gov, this trial enrolled 129 people in total across five treatment groups. Participants had diabetic macular oedema — a condition where fluid builds up in the central part of the retina at the back of the eye, which can affect vision. The five groups tested were: focal laser treatment alone (38 people); a steroid injection (triamcinolone) given behind the eye at a higher dose of 40 mg (21 people); the same steroid at a lower dose of 20 mg given slightly differently (23 people); the higher-dose steroid injection combined with laser (22 people); and the lower-dose steroid injection combined with laser (25 people). The trial measured changes in retinal swelling and vision scores over 34 weeks. The reported data shows that all five groups had some reduction in retinal swelling (measured in microns, a unit of thickness) from the start of the trial, with negative numbers indicating less swelling. At certain time points, the higher-dose steroid injection alone group showed a reduction of up to 47 microns, while the lower-dose steroid plus laser group showed reductions of up to 44 microns; the laser-only group showed smaller reductions of around 10–30 microns across the measured time points. For vision scores — measured on a scale where higher numbers mean better vision — the reported data shows that scores across all groups stayed broadly similar throughout the trial, generally remaining in the range of 77 to 80 out of a possible 97, with changes from the starting point of just a few points in either direction. Regarding the number of eyes needing re-treatment at 17 weeks, the reported data shows that the combined steroid-plus-laser groups had 9 eyes each requiring re-treatment, compared to 22 eyes in the laser-only group. The reported data also shows the number of eyes that achieved a 50% or greater reduction in retinal swelling at various time points, ranging from 2 to 11 eyes depending on the group and visit. The number of eyes reaching a retinal thickness below 250 microns — a threshold used to judge whether re-treatment was needed — also varied across groups and time points, with some groups reporting higher counts than others at particular visits. Note that not all time-point data appeared to be fully reported in the submitted results, so some figures across visits are not available in the data provided. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00687804 · results posted 19 April 2011
According to the results reported on ClinicalTrials.gov, this trial (NCT00687804) enrolled 345 people across three groups to study treatments for a eye condition affecting the retina (the light-sensitive layer at the back of the eye). Participants were assigned to receive either injections of a medicine called ranibizumab (0.5 mg) alone, ranibizumab combined with laser treatment, or laser treatment alone. The main thing being measured in the core 12-month study was how well participants could read letters on a vision chart, and how that changed over time. A follow-up extension phase of up to 24 months then looked at eye-related unwanted effects (called adverse events) in those who continued. The reported data shows that at the start of the core study, all three groups could read roughly similar numbers of letters on the chart (around 62–65 letters on average). By averaging results across all monthly check-ups over 12 months, the ranibizumab-alone group read about 6.1 more letters than at the start, the ranibizumab-plus-laser group read about 5.9 more letters, and the laser-alone group read about 0.8 more letters. The reported data also shows that the thickness of the central retina (measured in micrometres) decreased by around 119 micrometres in the ranibizumab-alone group, 128 micrometres in the combination group, and 61 micrometres in the laser-alone group. A questionnaire measuring how vision affected daily life (scored 0–100, where higher means better) showed increases of about 5 points in both ranibizumab groups and about 0.6 points in the laser group. Regarding the extension phase, the reported data shows that eye-related adverse events (unwanted effects in the treated eye) were recorded in approximately 56.6% of participants in each ranibizumab group, 52.5% of those from the original laser group who went on to receive ranibizumab in the extension, and 40.0% of those from the laser group who did not receive ranibizumab in the extension. Serious eye-related adverse events were reported in 2.4%, 1.2%, 1.7%, and 0.0% of participants in those same groups respectively. These figures describe what was recorded and counted — they do not on their own indicate whether any treatment is better or worse than another. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00605280 · results posted 30 March 2011
According to the results reported on ClinicalTrials.gov, this trial looked at a medicine called pegaptanib sodium (given as an injection into the eye) in people with diabetic eye disease that affects vision. The trial tested three different doses of the medicine (0.3 mg, 0.03 mg, and 0.003 mg) compared to a sham (pretend) procedure that involved no active medicine. A total of 317 people started the trial across all groups in Year 1 — 145 in the main 0.3 mg group and 143 in the sham group. The trial ran over two years, with a smaller optional third-year extension. The main thing the trial measured was how many people's vision improved by at least 10 letters (roughly two lines on an eye chart) after one year. The reported data shows that, for the primary measure at one year, 49 out of 145 participants in the 0.3 mg pegaptanib group had a vision improvement of 10 letters or more, compared to 25 out of 143 participants in the sham group. At two years, those numbers were 51 (pegaptanib 0.3 mg) versus 37 (sham). For a larger improvement of 15 letters or more, the reported numbers were 22 (pegaptanib) versus 13 (sham) at one year, and 30 versus 18 at two years. The reported data also shows results for changes in the degree of diabetic retinopathy (damage to the back of the eye). At one year, 4 eyes in the pegaptanib group showed a worsening of two or more steps on a retinopathy scale, compared to 12 eyes in the sham group. In the other direction, 10 eyes in the pegaptanib group showed an improvement of two or more steps, compared to 3 eyes in the sham group. No outcome data was reported for the lower-dose groups (0.03 mg and 0.003 mg) in these measures, so those figures are not available here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00485836 · results posted 25 February 2011
According to the results reported on ClinicalTrials.gov, this trial (NCT00485836) enrolled 392 people across three groups: 130 received a sham (dummy) injection, 132 received a lower dose of ranibizumab (0.3 mg), and 130 received a higher dose of ranibizumab (0.5 mg). The trial was measuring changes in vision over 6 months in people with a condition affecting the back of the eye. Vision was measured using a standard eye chart — participants scored points for each letter they could correctly read, and researchers tracked how those scores changed from the start of the trial to the 6-month mark. The reported data shows that, on average, the sham group's letter score went up by 0.8 letters from their starting point, while the 0.3 mg group went up by 12.7 letters and the 0.5 mg group went up by 14.9 letters. When looking at how many participants gained 15 or more letters (a meaningful improvement on this type of chart), the reported figures were 16.9% in the sham group, 46.2% in the 0.3 mg group, and 47.7% in the 0.5 mg group. For participants who avoided losing 15 or more letters, the reported figures were 84.6%, 96.2%, and 98.5% respectively. The trial also measured the thickness of a central part of the retina (the back of the eye) using a scanning technique. The reported data shows the sham group had an average reduction of 167.7 micrometres in thickness, compared with 433.7 micrometres in the 0.3 mg group and 452.3 micrometres in the 0.5 mg group. Additionally, a quality-of-life questionnaire about near-vision tasks showed average score increases of 5.1 points (sham), 10.2 points (0.3 mg), and 9.3 points (0.5 mg) from baseline. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00284050 · results posted 20 January 2011
According to the results reported on ClinicalTrials.gov, this trial (NCT00284050) enrolled 151 people across three groups: 51 received injections of ranibizumab at a lower dose (0.3 mg), 51 received a higher dose (0.5 mg), and 49 received a sham (dummy) injection as a comparison group. The trial was measuring changes in eyesight — specifically how well participants could read letters on a standardised eye chart — over 12 months. By the end of the study, 46, 46, and 40 participants completed the trial in each group respectively. The reported data shows two primary things being measured. First, looking at the average change in vision across all monthly check-ups over the year, the lower-dose group gained an average of 9.2 letters on the eye chart, the higher-dose group gained an average of 6.4 letters, and the sham group changed by an average of −0.1 letters (essentially no change). Second, looking specifically at the change in vision at the 12-month mark, the lower-dose group had gained an average of 11.8 letters, the higher-dose group 8.8 letters, and the sham group had lost an average of 1.4 letters. The reported data also shows a secondary measurement: the change in the thickness of the central part of the retina (the light-sensitive layer at the back of the eye), measured in micrometres (millionths of a metre). At 12 months, the lower-dose group showed an average reduction of 200.7 µm, the higher-dose group a reduction of 187.6 µm, and the sham group a reduction of 48.4 µm. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00367133 · results posted 9 July 2010
According to the results reported on ClinicalTrials.gov, this trial compared three different treatments for what appears to be diabetic macular oedema (swelling in the back of the eye related to diabetes). The three groups were: laser treatment (focal/grid laser photocoagulation), a low-dose steroid injection into the eye (1 mg triamcinolone), and a higher-dose steroid injection (4 mg triamcinolone). A total of 840 participants started the two-year phase of the trial — 330 in the laser group, 256 in the low-dose injection group, and 254 in the higher-dose injection group. A smaller subset continued into a three-year follow-up phase. The reported data shows that the main thing being measured was change in vision, scored using a standardised letter chart (where a higher score means better vision, and a positive change means improvement). Over two years, the median change in letter score was +4 letters for the laser group, +1 letter for the low-dose injection group, and +2 letters for the higher-dose injection group. When looking at the average (mean) change, the laser group scored +1 letter, while the low-dose injection group showed −2 letters and the higher-dose injection group −3 letters (a negative number meaning a slight decrease from their starting point). The reported data also shows measurements of the thickness of the central part of the retina (the light-sensitive layer at the back of the eye), which was measured in microns (thousandths of a millimetre). At two years, the median thickness readings were 243 microns for the laser group, 279 microns for the higher-dose injection group, and 305 microns for the low-dose injection group. In terms of change from the start of the trial, the mean reduction in thickness was 139 microns in the laser group, 86 microns in the low-dose injection group, and 77 microns in the higher-dose injection group — with a larger reduction indicating less swelling. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00168298 · results posted 26 August 2009
According to the results reported on ClinicalTrials.gov, this trial enrolled 668 people across three groups during its initial blinded phase: 226 received a 700 microgram dose of dexamethasone (a corticosteroid medicine delivered as an eye injection), 218 received a 350 microgram dose, and 224 received a sham (fake) injection. The trial was measuring changes in vision and the thickness of the retina (the light-sensitive layer at the back of the eye) in people with an eye condition affecting that area. The study had two phases — a blinded phase where participants did not know which treatment they received, followed by an open-label phase where all participants received the 700 microgram dose. The reported data shows that the main thing being measured was how many people could read at least 15 more letters on an eye chart than they could at the start of the trial. According to the results reported on ClinicalTrials.gov, 53 out of 226 people (about 21%) in the 700 microgram group, 48 out of 218 (about 22%) in the 350 microgram group, and 38 out of 224 (about 17%) in the sham injection group reached this milestone. For retinal thickness, the reported data shows that average thickness at the start of the study was around 542–574 microns across the three groups. By a later time point, the 700 microgram group had an average reduction of about 216 microns, the 350 microgram group about 206 microns, and the sham group about 91 microns. At a further follow-up point, reductions of around 132, 151, and 127 microns were reported for the three groups respectively. The reported data also shows that, looking at vision changes broken into categories, the proportion of people whose vision worsened by 15 or more letters appeared lower in the dexamethasone groups than in the sham group, though full figures for that category were not reported in the data provided. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00168324 · results posted 26 August 2009
According to the results reported on ClinicalTrials.gov, this trial enrolled 599 people in total across three groups. Participants received either a 700 microgram (µg) dose of a medicine called dexamethasone (201 people), a 350 µg dose of dexamethasone (196 people), or a sham (dummy) injection (202 people). The trial was looking at changes in vision in the treated eye, specifically whether people could read 15 or more additional letters on an eye chart compared to when they started — a commonly used way of measuring a meaningful improvement in vision. The trial also measured changes in the thickness of the retina (the light-sensitive layer at the back of the eye) over time. The reported data shows that the main outcome was tracked using a statistical method called a Kaplan-Meier estimate, which accounts for people who left the study early. This estimate runs from 0 to 1, where a higher number means a greater likelihood of achieving that 15-letter improvement. At the 180-day mark, the reported estimates were 0.397 for the 700 µg group, 0.349 for the 350 µg group, and 0.225 for the sham group. For retinal thickness, the reported data shows an average reduction (improvement) of about 199 µm in the 700 µg group, 144 µm in the 350 µg group, and 78 µm in the sham group at day 90. At the 180-day mark, all three groups showed smaller reductions — around 105 µm, 91 µm, and 110 µm respectively. Regarding vision category changes at day 90, 22.4% of the 700 µg group, 20.9% of the 350 µg group, and 12.4% of the sham group were reported to have improved by 15 or more letters. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
Read the full trial page · View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
See the full Retinal Vein Occlusion and Diabetic Macular Oedema page · What changed recently
Not medical advice. These are results as reported by the trial sponsor to a public registry, summarised in plain English. They describe what a trial recorded, not whether a treatment is suitable for any person. Verify anything important against the original registry record and discuss what it means for you with your doctor.