Reported trial results for Uveitis

Every Uveitis 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.

74 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

NCT05286203 · results posted 26 June 2026

According to the results reported on ClinicalTrials.gov, this trial (called OPTICS) looked at people with a type of serious eye inflammation that may be caused by infection. The trial ran in two phases. In Phase I, 100 people took part and 92 completed that phase. In Phase II, participants were split into two groups: 12 people received standard diagnostic care and 9 people had a specialised test called Metagenomic Deep Sequencing (MDS), which analyses genetic material to look for signs of infection. The trial was measuring things like eye improvement, whether treatment was considered appropriate by experts, how certain doctors were about a diagnosis, patients' quality of life, and how well different diagnostic approaches performed. The reported data shows that for the main outcomes in Phase II, 7 out of 12 people in the standard care group and 8 out of 9 in the MDS group showed clinical improvement (such as reduced eye inflammation or better vision scores), while 4 in the standard care group and 1 in the MDS group did not show that improvement. When an independent expert panel judged whether treatment was appropriate, 11 out of 12 in the standard care group and 8 out of 9 in the MDS group were rated as receiving appropriate therapy. On a scale of 0–100% measuring how certain doctors felt about an infection diagnosis, the reported figure was 57.5% for the standard care group and 95% for the MDS group. For patient quality of life (scored 0–100, where higher means better vision function), the reported scores were 62.8 for the standard care group and 75.6 for the MDS group. The reported data from Phase I also compared three different ways of identifying infection. Using a statistical method called Latent Class Analysis — which estimates how well each approach correctly identifies cases — the clinician's own assessment correctly identified around 96% of infection cases but only correctly ruled out infection around 38% of the time. Conventional diagnostic tests correctly identified around 53% of infection cases but correctly ruled out infection around 97% of the time. The MDS test correctly identified around 78% of infection cases and correctly ruled out infection around 89% of the time. 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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NCT05042609 · results posted 20 May 2026

According to the results reported on ClinicalTrials.gov, this trial (NCT05042609) enrolled 139 participants in total — 90 in the TRS01 group and 49 in the Active Comparator group. The trial was measuring eye inflammation, specifically looking at cells visible in the front part of the eye (called the anterior chamber) as a way to track how inflammation changed over 28 days. The main question the trial asked was how many participants had no detectable inflammation cells by Day 28. The reported data shows that by Day 28, 44 participants in the TRS01 group and 15 in the Active Comparator group had a complete absence of inflammation cells (a score of zero). When a slightly broader measure was used — counting either zero cells or only a trace amount — 52 participants in the TRS01 group and 42 in the Active Comparator group met that threshold at Day 28. For a secondary measure looking at the average change in inflammation score from the start of the trial to Day 28 (on a scale of 0 to 4, where 0 means no inflammation and 4 means severe), the TRS01 group showed an average decrease of 1.9 points, while the Active Comparator group showed an average decrease of 2.2 points. Similar patterns were also reported at Day 21, an earlier check-in point during the trial. The reported data also shows that at Day 21, 32 participants in the TRS01 group and 29 in the Active Comparator group had a complete absence of inflammation cells, while 50 and 40 participants respectively had either zero or trace-level cells. The average change in inflammation score from the start to Day 21 was a decrease of 1.7 points for TRS01 and 2.1 points for the Active Comparator 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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NCT03586284 · results posted 10 February 2026

According to the results reported on ClinicalTrials.gov, this trial enrolled 51 people across three groups: 19 received oral valganciclovir (an antiviral tablet), 15 received topical ganciclovir 2% (an antiviral eye drop), and 17 received a placebo (a dummy treatment with no active ingredient). The trial was measuring changes in the amount of a virus called CMV (cytomegalovirus) detected inside the eye, as well as whether participants' eye inflammation settled down by the end of the study. Not everyone completed the trial — all 19 in the oral tablet group finished, while 2 people in each of the other two groups did not complete it. The reported data shows that the primary measurement — the reduction in CMV virus levels inside the eye after 7 days — differed across the three groups. Virus levels in the oral valganciclovir group dropped by an average of 0.59 units (on a logarithmic scale, meaning roughly a fourfold reduction), the topical ganciclovir group dropped by 0.23 units, and the placebo group dropped by 0.04 units. For the secondary outcome looking at how many participants reached a state of reduced eye inflammation by the final visit, the reported data shows the numbers were 19 out of 19 in the oral tablet group, 13 out of 13 in the eye drop group, and 15 out of 15 in the placebo group — meaning all participants who completed the trial were counted in this outcome. Regarding the effect of steroid eye drops used before the trial started, the reported data shows the same figure (0.10 IU/mL) across all three groups, though no further breakdown of what this means was provided 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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NCT03841357 · results posted 23 January 2026

According to the results reported on ClinicalTrials.gov, this trial looked at whether a medicine called abatacept (given alongside usual care) might influence the course of a form of childhood arthritis compared to usual care alone. The trial ran across two parts. In Part I, 20 participants received abatacept plus usual care and 20 received usual care only. In Part II, 81 participants received abatacept plus usual care and 662 received usual care only — making a total of 783 participants across both parts. The trial tracked participants for roughly 14 months and measured several things: whether they developed widespread joint involvement (5 or more active joints, called polyarthritis), eye inflammation (uveitis), or needed to start stronger medicines such as steroids or other disease-modifying drugs. The reported data shows the following numbers for the combined (pooled) results across both parts of the trial. Out of 101 participants who received abatacept plus usual care, 54 reached at least one of the main tracked events, compared with 259 out of 682 participants in the usual care group. Looking at the individual tracked events in the pooled groups: polyarthritis was recorded in 22 abatacept participants versus 55 in the usual care group; uveitis was recorded in 5 abatacept participants versus 31 in the usual care group; and starting stronger systemic medicines was recorded in 52 abatacept participants versus 243 in the usual care group. For the secondary measures, the reported data shows that 48 participants in the abatacept group and 264 in the usual care group were recorded as having clinically inactive disease or remission at some point during the study. Disease spread (developing polyarthritis or uveitis) was recorded in 18 abatacept participants and 73 usual care participants across the pooled groups. It is important to note that the two groups were very different in size, so the raw numbers alone do not tell the full story — the groups had notably different numbers of 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.

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NCT03828019 · results posted 16 May 2025

According to the results reported on ClinicalTrials.gov, this trial (NCT03828019) enrolled 227 people with uveitis (inflammation inside the eye) — 114 in a group receiving adalimumab (a type of injection-based medicine) and 113 in a group receiving conventional immunosuppression (standard medicines that reduce the immune system's activity). The trial was primarily measuring how many participants in each group were able to reduce their steroid (corticosteroid) dose to a low level — 7.5 mg per day or less — while also having their eye inflammation become inactive, across the first six months. It also tracked several secondary measures over 12 months, including whether steroids could be stopped altogether and whether vision changed. The reported data shows that by six months, approximately 69% of participants in the adalimumab group and 54% in the conventional immunosuppression group met the main target of having low or no steroid use alongside inactive eye inflammation. By 12 months, these figures were reported as approximately 86% and 77% respectively. For the more demanding goal of stopping steroids entirely while maintaining inactive inflammation, the reported data shows around 15% (adalimumab) and 11% (conventional immunosuppression) had achieved this by six months, rising to around 55% and 40% by 12 months. For average steroid use over the full 12 months, the reported figures were 11.8 mg/day for the adalimumab group and 13.8 mg/day for the conventional immunosuppression group. Regarding vision, the trial measured changes in how many letters participants could read on a standard eye chart (where reading more letters means better vision). The reported data shows an average improvement of 3.6 letters in the adalimumab group and 3.2 letters in the conventional immunosuppression group over 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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NCT03816397 · results posted 26 March 2025

According to the results reported on ClinicalTrials.gov, this trial (NCT03816397) involved 87 people with a condition involving eye inflammation (ocular inflammation) linked to joint disease. Participants were split into two groups: 43 people continued taking a medicine called adalimumab, and 44 people stopped taking it. The trial was measuring how long it took before signs of eye or joint inflammation came back — called "treatment failure" — after being assigned to one of these two approaches. The reported data shows that for the group who stopped adalimumab, the median time to treatment failure was 119 days (roughly four months). This means that, based on the data, half of the people in the "stop" group had a return of inflammation within about 119 days, and half took longer than that. For the group who continued taking adalimumab, the median time to treatment failure was reported as "NA" (not available or not reached), which typically means that during the study period, fewer than half of participants in that group experienced a return of inflammation — however, the specific reason this figure was not available is not explained in the reported data. It is also worth noting that more participants in the "continue" group did not complete the study (14 out of 43) compared to the "stop" group (7 out of 44), though the reasons for this are not detailed 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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NCT03811366 · results posted 22 November 2024

According to the results reported on ClinicalTrials.gov, this trial (NCT03811366) enrolled 12 participants, all of whom completed the study — none dropped out. All participants received corticosteroid monotherapy (treatment with steroids only, without other medicines). The trial was measuring the health of the retina (the light-sensitive layer at the back of the eye) using a test called an electroretinogram (ERG), which records the electrical signals the retina produces in response to light. These measurements were taken at 12 months and again at 24 months. The trial also tracked other signs of eye inflammation, including cells in the front of the eye, changes seen on specialised eye scans, and changes in the thickness of a layer at the back of the eye called the choroid. The reported data shows that, at 12 months, the median (middle value) ERG readings for the group ranged from 42 to 508 microvolts across the different signal types measured. At 24 months, those readings ranged from 43 to 484 microvolts. When comparing the 24-month readings to the 12-month readings, the trial divided participants into two subgroups: those whose ERG readings stayed relatively stable, and those whose readings worsened (defined as a drop of 30% or more in any measured signal). The reported data shows the stable group had changes ranging from 0% to +9.5% (little to no change), while the worsening group had changes ranging from approximately −5% to −47.1% (a decline in those readings). For the secondary measurements, the reported data shows that in the stable ERG group, 8 eyes had a recurrence or worsening of inflammatory cells at the front of the eye, compared with 0 eyes in the worsening ERG group. For the specialised eye scan (indocyanine green angiography), 17 eyes in the stable group and 5 eyes in the worsening group showed an increase in a score used to measure inflammation-related changes. For choroidal thickness, 8 eyes in the stable group and 4 eyes in the worsening group showed an increase of 30% 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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NCT03634475 · results posted 9 October 2024

According to the results reported on ClinicalTrials.gov, this trial (NCT03634475) enrolled 12 participants, all of whom completed the study with none dropping out. The trial involved a single injection of a treatment called PP-001 directly into the eye (known as an intravitreal injection) and was designed to test it in people with chronic, non-infectious uveitis — a condition involving ongoing inflammation inside the eye. The trial used increasing doses across participants to look at how the treatment was tolerated. The reported data shows that the primary outcome being measured was the number of participants who experienced what are called "treatment emergent adverse events" — meaning any unwanted or unexpected health events that occurred after receiving the injection. According to the results reported on ClinicalTrials.gov, all 12 participants were counted in this measurement. However, the submitted data does not include a breakdown of how many participants, if any, actually experienced such events, or what those events were — only that 12 participants were assessed. No secondary outcome measure 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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NCT04088409 · results posted 13 August 2024

According to the results reported on ClinicalTrials.gov, this trial (NCT04088409) looked at two medicines — baricitinib and adalimumab — in children and young people with a condition causing inflammation inside the eye (uveitis). In the first part of the trial (Part A), 25 participants were assigned to baricitinib and 5 to adalimumab. Of those, 24 and 5 respectively received at least one dose. The trial was primarily measuring how many participants showed a meaningful reduction in eye inflammation by week 24, using a recognised grading system called the SUN criteria, which looks at the level of inflammatory cells in the front part of the eye. The reported data shows that, in the baricitinib group, 33.3% of participants met the definition of a "responder" at week 24 — meaning roughly one in three showed the required reduction in eye inflammation according to the SUN criteria. No equivalent figure was reported for the adalimumab group, which had very small numbers. For all of the secondary outcome measures — including changes in eye inflammation scores, vision test results, and a measure called vitreous haze (cloudiness inside the eye) — the reported data states that results would be provided after the study was completed, meaning those figures were not available in the submitted results. It is also worth noting that the trial had two parts: in Part B, 10 participants from the baricitinib group started but none completed, and no secondary outcome data was reported for this stage either. The reasons participants did not complete each part 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.

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NCT03711929 · results posted 4 December 2023

According to the results reported on ClinicalTrials.gov, this trial (NCT03711929) enrolled 145 participants across three groups during its first, double-masked phase: 57 received DE-109 injectable solution (the test treatment), 59 received a sham (dummy) procedure as a control, and 29 received DE-109 in a third "dummy arm." The trial was measuring eye inflammation — specifically a cloudiness inside the eye called "vitreous haze" — in people with a condition called uveitis (inflammation at the back of the eye). The main question the trial asked was: what proportion of treated eyes reached a vitreous haze score of zero (meaning no detectable inflammation) by the fifth month? The reported data shows that at month 5 — the primary measurement point — 15.7% of eyes in the main DE-109 group, 12.2% of eyes in the sham (control) group, and 28.7% of eyes in the dummy DE-109 arm reached a vitreous haze score of zero. At the earlier month 3 check, the reported figures were 14.7%, 5.5%, and 15.4% respectively. The trial also used a broader "composite score" (a scale from −1 to 3 that factored in improvement, worsening, and whether rescue treatments were needed). The reported data shows the average composite scores at month 3 were 0.4, 0.3, and 0.4 for the three groups, and at month 5 were 0.3, 0.3, and 0.6 respectively — all sitting near the lower end of that scale. These numbers are what was recorded and submitted; they do not on their own tell us whether any difference between the groups is meaningful, and no conclusions about why differences appeared between arms should be drawn from this summary 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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NCT04222712 · results posted 5 October 2023

According to the results reported on ClinicalTrials.gov, this trial (NCT04222712) enrolled 16 people in total, split into two groups of 8 — one group received a lower dose of a treatment called TRS01, and the other received a higher dose. All 16 participants completed the study with no one dropping out. The trial was measuring adverse events, meaning any unwanted or unexpected health experiences that occurred during the study, both in the eyes and throughout the body more broadly. The reported data shows that in the low dose group, 2 out of 8 participants experienced adverse events during the study. In the high dose group, 5 out of 8 participants experienced adverse events. This was the only outcome measure reported in the structured results submitted to ClinicalTrials.gov. No other outcome figures — such as measures of how well the treatment may have worked — were included 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.

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NCT02623426 · results posted 10 July 2023

According to the results reported on ClinicalTrials.gov, this trial (NCT02623426) enrolled 194 people across three groups. Each group received a different treatment injected into the eye for a condition affecting the retina: 65 people received a dexamethasone pellet (Ozurdex), 65 received methotrexate, and 64 received ranibizumab (Lucentis). The trial was measuring changes in the thickness of a specific layer at the centre of the retina — called the central subfield — using eye-scanning technology, comparing thickness at the start of the trial to thickness at 12 weeks. Most participants completed the study, with only a small number (1–3 per group) not finishing. The reported data shows the primary outcome as a proportion — that is, a fraction of the original retinal thickness measured at the start. A number below 1.0 means the retina appeared thinner at 12 weeks compared to the start, with lower numbers representing a greater reduction in thickness. According to the results reported on ClinicalTrials.gov, at 12 weeks the dexamethasone group had a reported proportion of 0.65 (meaning the retina measured about 65% of its original thickness), the methotrexate group had a proportion of 0.88 (about 88% of original thickness), and the ranibizumab group had a proportion of 0.79 (about 79% of original thickness). No other outcome measures were included in the submitted results data. Data on secondary outcomes, if any were collected, was not reported in the structured results 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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NCT03660618 · results posted 10 May 2023

According to the results reported on ClinicalTrials.gov, this trial enrolled just one participant, listed under the group "Clinic Subjects." The trial was focused on imaging blood flow in body tissue, which the study described as an important area of interest in clinical settings. The reported data shows that the one participant both started and completed the study, with no participants recorded as dropping out. However, for the primary outcome measure — imaging blood flow in tissue — no numerical results or measurements were submitted to ClinicalTrials.gov. This means it is not possible to describe what the imaging found, as that data was not reported. Because only one person took part and no outcome numbers were provided, very little can be drawn from this submission about what the trial found. 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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NCT02406209 · results posted 27 March 2023

According to the results reported on ClinicalTrials.gov, this trial (NCT02406209) enrolled 45 people across three groups to compare different eye drop treatments for eye inflammation. The three groups were: NS2 eye drops (0.5%) alone (15 people); NS2 (0.5%) combined with Pred Forte® (0.1%) eye drops (16 people); and Pred Forte® (1%) eye drops alone (14 people). Roughly half of the participants in each group completed the study — 7, 7, and 6 people respectively — while the remainder did not finish. The main thing the trial measured was a score called the "anterior chamber cell grade" — a scale from 0 to 4 that rates the level of inflammatory cells visible inside the eye, where 0 means none and 4 means severe. The reported data shows the change in this score from the start of the trial to week 8. The NS2-only group showed an average change of −0.7 units on that scale; the NS2 combined with low-dose Pred Forte® group showed a change of −0.9 units; and the standard Pred Forte® (1%) group showed a change of −0.5 units. A negative number means the score went down (i.e., moved toward fewer cells) compared to the starting point. No secondary outcome data was reported in the submitted results. It is worth noting that the relatively small number of people who completed each group makes these numbers difficult to draw broad conclusions from. 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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NCT04976777 · results posted 28 February 2023

According to the results reported on ClinicalTrials.gov, this trial (NCT04976777) involved 54 people in total. Participants were split into two groups: 36 people received an updated version of a dexamethasone eye implant delivery system (called the Updated DEX PS DDS 0.7 mg), and 18 people received the already-approved version of the same delivery system (Approved DEX PS DDS 0.7 mg). The trial was primarily measuring how many participants in each group experienced at least one unwanted medical event (called an adverse event) during the study period. Nearly all participants finished the study — 35 out of 36 in the updated device group, and all 18 in the approved device group. The reported data shows that in the updated device group, 13 out of 36 participants experienced at least one adverse event. In the approved device group, 7 out of 18 participants experienced at least one adverse event. The trial also set out to measure how well the updated applicator device physically performed when delivering the implant into the eye, but no numerical results for that outcome 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.

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NCT04200833 · results posted 5 May 2022

According to the results reported on ClinicalTrials.gov, this trial (NCT04200833) enrolled 10 participants, all in a single group, and all 10 completed the study with no dropouts. The trial was looking at golimumab (an injection-based medicine) as a treatment for uveitis — a type of eye inflammation. The main thing researchers were measuring was how many participants' eye inflammation reached a "complete response," meaning the inflammation in the front of the eye fully settled down to the lowest possible level. They also tracked vision, eye discomfort, and whether participants were able to reduce their steroid dose over 12 months. The reported data shows that out of the 10 participants, 8 were recorded as "complete responders" — meaning their eye inflammation reached that fully settled level. For vision, the reported average score was 0.27 on the LogMAR scale (a standard way of measuring eyesight, where a lower number generally reflects better vision). The reported data shows that 0 participants reported ocular discomfort such as eye soreness or light sensitivity. Regarding steroid use, the reported data shows an average reduction of 0.19 mg/kg per day in systemic (whole-body) steroid dose at the 12-month point compared to the start of the trial. It is worth noting that this was a very small study of only 10 people, and the data as submitted does not include comparison figures or further statistical detail for some measures. 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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NCT03584724 · results posted 28 March 2022

According to the results reported on ClinicalTrials.gov, this trial looked at a product called Norflo Oro compared to a placebo (a dummy treatment with no active ingredient) in people with a specific type of eye inflammation called HLA-B27 uveitis. A total of 49 people were enrolled — 25 in the Norflo Oro group and 24 in the placebo group. Of those, 18 in the Norflo Oro group and 23 in the placebo group completed the full 12-month study. The main thing the trial was measuring was whether the number of uveitis flare-ups (episodes where the eye inflammation returned) changed over the 12 months of the study compared to the 12 months before it started. The reported data shows that, on average, people in the Norflo Oro group had 0.35 flare-ups per person during the study period, while people in the placebo group had 0.58 flare-ups per person. Both figures represent a change from each group's starting point before the trial began. The trial also tracked eye pressure (measured in mmHg — a standard unit for pressure) as a secondary measure. The reported data shows small changes in eye pressure in both groups, though the full details across all measurement points were not straightforwardly separated in the submitted data, so those figures should be interpreted 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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NCT03207815 · results posted 21 January 2022

According to the results reported on ClinicalTrials.gov, this trial (NCT03207815) enrolled 74 people with active non-infectious uveitis (inflammation inside the eye not caused by infection) — 38 received filgotinib, an investigational oral medicine, and 36 received a placebo (a dummy pill with no active ingredient). The trial ran for up to 52 weeks and was primarily measuring how many participants in each group experienced what the researchers called "treatment failure" by week 24 — meaning their eye inflammation got worse or did not improve enough according to set criteria, such as new areas of inflammation appearing, inflammation scores not coming down to target levels, or vision worsening by a meaningful amount. The reported data shows that by week 24, 37.5% of participants in the filgotinib group met the criteria for treatment failure, compared with 67.6% in the placebo group. For the secondary measure of how quickly treatment failure occurred (from week 6 onward), the reported data shows a median time of 22.0 weeks in the placebo group; a median figure was not reported for the filgotinib group, which in this context means treatment failure did not occur in at least half of that group during the study period. For the remaining secondary measures — changes in eye inflammation scores (vitreous haze and anterior chamber cell grades), vision scores, and retinal thickness — small numerical changes were reported in both groups at week 52, but the data as submitted does not include the additional detail needed to describe meaningful differences between the groups for those measures. 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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NCT03656692 · results posted 3 August 2021

According to the results reported on ClinicalTrials.gov, this trial looked at a single treatment group of people receiving Acthar Gel, a medication being studied for use in uveitis — a condition involving inflammation inside the eye. Five people started the trial, two completed it, and three did not finish. The trial was measuring three main things related to eye inflammation: the degree of haziness in vision (using the Nussenblatt Grading Scale), the amount of protein floating in the fluid at the front of the eye (using the Laser Flare Scale), and the number of cells floating in that same fluid (using the Aqueous Cell Scale). A secondary measurement tracked eye pressure over a 24-hour period, known as diurnal intraocular pressure, recorded in millimetres of mercury (mmHg). The reported data shows that no numerical results were submitted to ClinicalTrials.gov for any of these outcome measures — not for the three primary inflammation scales, nor for the eye pressure measurement. Because the data was not reported, it is not possible to describe what scores or readings were recorded for participants during the trial. It is also worth noting that only two of the five participants completed the study, which was a very small number to begin with. 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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NCT03097315 · results posted 15 June 2021

According to the results reported on ClinicalTrials.gov, this trial (NCT03097315) enrolled 38 adults who received a 4 mg injection of a medicine called CLS-TA delivered into a specific layer at the back of the eye (the suprachoroidal space). The trial was studying a condition called uveitis — inflammation inside the eye — and was measuring things like unwanted medical events (adverse events), eye pressure, and several signs of eye inflammation at different points in time. The reported data shows that 27 out of 38 participants experienced at least one treatment-emergent adverse event (an unwanted medical event that occurred after receiving the injection), and 1 participant experienced a serious adverse event (a more severe medical event meeting specific criteria such as requiring hospitalisation). Regarding eye pressure, the reported average was 13.3 mmHg at one time point and 15.2 mmHg at another (normal eye pressure is generally considered to be in a range up to around 21 mmHg, though this trial did not report a comparison figure). For the inflammation measures, the number of participants recorded as having the lowest possible inflammation score (grade 0 — meaning little to no detectable inflammation) increased between the two reported time points: for inflammatory cells in the front of the eye, this went from 17 to 31 participants; for fluid-related inflammation in the front of the eye ("flare"), from 27 to 34 participants; and for haziness in the centre of the eye, from 17 to 34 participants. The trial did not report whether these changes were statistically meaningful, and no comparison group was included in this single-group 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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NCT02952001 · results posted 7 May 2021

According to the results reported on ClinicalTrials.gov, this trial (NCT02952001) was an extension study that followed on from an earlier trial involving people with uveitis — an inflammatory condition affecting the eye. A total of 28 people continued in the group that had received a 4 mg injection of CLS-TA (delivered into a specific layer at the back of the eye called the suprachoroidal space), while 5 people continued in the group that had received a sham (dummy) procedure. The study was measuring how long it took before participants needed additional treatment for their uveitis, as well as tracking changes in eye swelling, vision, and any adverse (unwanted) events. The reported data shows that the median time before additional uveitis treatment was needed was 344 days for the injection group and 332 days for the sham group. For eye swelling — measured as the thickness of a small central area of the retina — the injection group showed an average reduction of 174.5 microns (a unit of measurement smaller than a millimetre) from their starting point, while the sham group showed an average increase of 19.5 microns. For vision, measured by the number of letters read correctly on a standard eye chart, the injection group showed an average improvement of 12.1 letters and the sham group showed an average improvement of 14.0 letters. Regarding adverse events, 16 out of 28 participants in the injection group and 3 out of 5 in the sham group reported at least one treatment-emergent adverse event; serious adverse events were reported by 1 participant in the injection group and 0 in the sham group. No further detail about the nature of those events was included in the reported data. It is worth noting that the numbers of participants in this study — particularly in the sham group — were quite small, and a notable proportion of participants did not complete the study (14 in the injection group and 3 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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NCT02595398 · results posted 28 April 2021

According to the results reported on ClinicalTrials.gov, this trial enrolled 160 people in total — 96 received an injection of a drug called CLS-TA delivered into a specific layer at the back of the eye (called a suprachoroidal injection), while 64 underwent a sham (fake) procedure as a comparison group. The trial was primarily measuring how many participants had a meaningful improvement in their vision — specifically, reading at least 15 more letters on an eye chart — after 24 weeks. The reported data shows that in the injection group, 45 out of 96 participants reached that 15-letter improvement mark, compared with 10 out of 64 in the sham group. For a secondary measure, the trial tracked changes in the thickness of the central part of the retina (a layer at the back of the eye) — where a reduction in thickness can indicate less swelling. The reported data shows the injection group had an average reduction of about 153 micrometres (a very small unit of measurement), while the sham group had an average reduction of about 18 micrometres. Regarding reported side effects, 67 of 96 participants in the injection group and 45 of 64 in the sham group experienced at least one treatment-related adverse event (an unwanted health occurrence noted during the study). Serious adverse events were reported in 3 participants in the injection group and none 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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NCT02911116 · results posted 26 March 2021

According to the results reported on ClinicalTrials.gov, this trial enrolled eight people in total, split into two groups. Five participants received the treatment by injection under the skin only (Cohort 1), and three received it first through a drip into a vein and then by injection under the skin (Cohort 2). The trial was looking at a condition involving inflammation inside the eye (uveitis), and the main thing it set out to measure was how many people in each group showed a "treatment response" by Week 16 — meaning their eye inflammation had settled down according to specific criteria for things like fluid leakage and cell activity in the eye. One person in each group did not complete the study. The reported data shows that by Week 16, all participants who completed the study met the criteria for a treatment response — that was 4 out of 5 in Cohort 1 and 2 out of 3 in Cohort 2. For vision (measured as the number of letters read correctly on an eye chart), the reported changes from the starting point were small across both eyes and both groups at each check-up visit — generally shifting by only a few letters up or down at Weeks 4, 8, 12, 16, and 28. The reported data also shows that no participants in either group experienced a return of their uveitis symptoms at the Week 4, 8, or 12 check-ups; at Week 16, one participant in Cohort 1 was recorded as having a recurrence, while none in Cohort 2 did. It is worth noting that this was a very small trial with only eight participants, so 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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NCT01789320 · results posted 21 February 2021

According to the results reported on ClinicalTrials.gov, this trial enrolled 11 participants, all of whom received an eye injection of a corticosteroid medication called triamcinolone acetonide (brand name Triesence®). Nine participants completed the study, while two did not finish. The trial was measuring changes in eye pressure, vision sharpness, retinal thickness, and the degree of cloudiness inside the eye (called vitreous haze) over a period of up to 26 weeks. The reported data shows that eye pressure (the fluid pressure inside the eye, measured in millimetres of mercury) changed by an average of −0.1 mm Hg from the starting point at week 8 — meaning it was almost unchanged. For vision sharpness, the reported data shows an average change of −0.25 units at week 8 and −0.28 units at week 26 on the scale used (where a negative number indicates an improvement in vision on that particular scoring system). Regarding retinal thickness — a measure of swelling at the centre of the retina — the reported data shows an average reduction of approximately 154 microns at week 8 and 107 microns at week 26, where a negative number indicates the retina became thinner. For vitreous haze (cloudiness inside the eye, scored on a scale where higher numbers mean more cloudiness), the reported data shows an average reduction of 0.75 score points at both week 8 and week 26. 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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NCT02255032 · results posted 8 February 2021

According to the results reported on ClinicalTrials.gov, this trial (NCT02255032) enrolled 22 people in total — 17 received a higher dose (4 mg) of a treatment called CLS-TA, and 5 received a lower dose (0.8 mg). All 22 participants completed the trial with no drop-outs. The trial was looking at swelling at the back of the eye (a condition called macular oedema) in people with uveitis, an inflammatory eye condition. Specifically, it measured the thickness of a central area at the back of the eye — called the central subfield — using a scanning technology that produces detailed images of the eye's layers. The reported data shows that the main thing being tracked was how much that central eye thickness changed between the start of the trial and after treatment, measured in microns (a micron is one-thousandth of a millimetre). In the group receiving the higher 4 mg dose, the average thickness decreased by approximately 164 microns from their starting measurement. In the group receiving the lower 0.8 mg dose, the average thickness decreased by approximately 78 microns from their starting measurement. No other outcome measures were included in the submitted results data. It is worth noting that this was a small trial, and the two groups had very different numbers of participants (17 versus 5), which the reported data does not explain 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.

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NCT03580343 · results posted 1 February 2021

According to the results reported on ClinicalTrials.gov, this trial enrolled 5 participants, all of whom were in a single group receiving a treatment called tofacitinib. Four of the five participants completed the study, while one did not finish. The trial was measuring a combined ("composite") outcome called "treatment failure," which was defined as any one of the following occurring: new areas of eye inflammation appearing compared to the start of the trial, a significant worsening of inflammation inside the eye (measured by the amount of cells visible in specific parts of the eye), or a meaningful drop in vision as measured on a standard eye chart. The reported data shows that, out of the 5 participants, 0 met the criteria for "treatment failure" during the study period. In other words, according to the reported numbers, none of the participants experienced the specific worsening events that the trial was tracking. It is worth noting that this was a very small number of participants, and no other outcome measures (such as secondary outcomes) 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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NCT03020992 · results posted 31 December 2020

According to the results reported on ClinicalTrials.gov, this trial (NCT03020992) enrolled 89 people, all of whom received the medicine certolizumab pegol. All participants had active axial spondyloarthritis (a type of inflammatory spinal condition) and a history of anterior uveitis — a painful inflammation at the front of the eye. Eighty-three of the 89 participants completed the study. The trial was mainly measuring how often eye flare-ups (new episodes of anterior uveitis requiring treatment from an eye specialist) occurred during the treatment period. The reported data shows that, looking at the primary outcome, participants experienced an average of 1.9 eye flare-ups before the treatment period, compared with 0.3 during it. For the secondary outcomes, the rate of eye flare-ups was reported as 132.72 flares per 100 patient-years (a way of counting events across the whole group over time) before treatment began, dropping to 18.56 flares per 100 patient-years by week 48, and 17.67 per 100 patient-years by week 96. The reported data shows the same figures applied to the subgroup of participants who had experienced at least one flare-up in the 12 months before the study started. A separate secondary measure tracked overall disease activity using a scoring tool called the ASDAS; the reported data shows an average change of −1.55 points from the start of the study to week 48, where a negative number indicates a lower score (noting that context for interpreting this scale was not fully 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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NCT02746991 · results posted 7 July 2020

According to the results reported on ClinicalTrials.gov, this trial (NCT02746991) enrolled 153 people in total — 52 received a sham (dummy) injection and 101 received a fluocinolone acetonide intravitreal (FAI) insert, which is a small implant placed in the eye. The trial was measuring how often a condition called uveitis (inflammation inside the eye) came back in the treated eye, first over a 6-month period and then over a longer 36-month (3-year) period. Not everyone completed the study — 24 out of 52 in the sham group and 67 out of 101 in the FAI insert group finished. The reported data shows that within 6 months, 28 participants in the sham injection group and 22 participants in the FAI insert group had a recurrence (return) of uveitis in their study eye. Over the longer 36-month follow-up period, the reported data shows that 39 participants in the sham group and 47 participants in the FAI insert group experienced a recurrence of uveitis. It is worth noting these are raw counts of participants, and the two groups started with different numbers of people, so direct comparison of the numbers alone does not tell the full story. The reported data shows only the number of participants with recurrences; no further breakdown of severity or other details 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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NCT02756650 · results posted 11 June 2020

According to the results reported on ClinicalTrials.gov, this trial involved 8 participants, all of whom received a treatment called ACZ885N (also known as canakinumab). The trial was exploring its use in people with Neuro-Behçet's Disease — a rare condition where Behçet's Disease affects the nervous system. Six of the eight participants completed the trial, and two did not. The trial was described as an exploratory study, meaning it was not designed to draw firm statistical conclusions — it was intended to gather early information rather than definitively test whether the treatment works. The reported data shows the following across several measurements. For the question of how many participants experienced disease attacks (flare-ups) during the study, the number reported was zero — meaning no attacks were recorded among participants during the study period. Of the 8 participants, only 3 were assessed in a neurology clinic and had their neurological function measured using three separate disability scales. On the Modified Expanded Disability Status Scale (a 0–10 scale where higher means more disability), the average reported score for those 3 participants was 1.16. On the Neuro-Behçet's Disability Score (a 0–8 scale, where 8 represents the most severe outcome), the average reported score was 0.66. On the Modified Rankin Scale (a 0–5 scale measuring how much help a person needs day-to-day, where 5 is the worst), the average reported score was also 0.66. One of the 3 neurologically assessed participants was reported to have ataxia (problems with balance and coordination). Muscle strength scores across all four limbs were reported as near-maximum for most limbs assessed, with one limb group averaging 4.7 out of 5. It is important to note that because only 8 people took part — and some measures were only recorded for 3 of them — the reported data is very limited in scope. 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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NCT02748512 · results posted 1 May 2020

According to the results reported on ClinicalTrials.gov, this trial involved 26 people in total — 14 assigned to use a newer device called the Mk II Inserter and 12 assigned to use an older version called the Mk I Inserter. One person from each group did not complete the trial. The study was looking at a small implant placed into the eye (called a fluocinolone acetonide insert, or FAI insert) and comparing how easy it was for doctors to use each version of the inserter device, as well as tracking certain eye-related events over 12 months. The reported data shows that for the primary measurement — whether the insertion procedure was rated by the doctor as satisfactory (meaning "Very Easy," "Easy," or "Routine") — 10 eyes in the Mk II group and 3 eyes in the Mk I group received a satisfactory rating. The reported data also shows that 3 eyes in the Mk II group and 2 eyes in the Mk I group fell into another rating category, with further breakdowns across additional rating levels. For the secondary measurement, which tracked specific eye-related events over 12 months, the reported data shows that 12 eyes in the Mk II group and 7 in the Mk I group were noted in one category, 1 eye in each group in another, 10 eyes in the Mk II group and 4 in the Mk I group in a further category, and no eyes in either group in two other categories. One eye in the Mk I group was noted in a remaining category, and none in the Mk II group. Detailed labels for each of these specific categories were not 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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NCT01694186 · results posted 23 March 2020

According to the results reported on ClinicalTrials.gov, this trial (NCT01694186) looked at a treatment for uveitis — a condition involving inflammation inside the eye. It enrolled 129 people in total: 42 received a sham (fake) injection as a comparison group, and 87 received an insert called the FAI (fluocinolone acetonide intravitreal) insert, which is a small device placed inside the eye to slowly release medicine. The main things being measured were whether the eye inflammation came back within 6 months of treatment, and what unwanted eye-related events occurred over 36 months. The reported data shows that when it came to the inflammation coming back within 6 months, 12 out of 42 people in the sham group had a recurrence, compared with 5 out of 87 people in the FAI insert group. Regarding eye-related unwanted events tracked over the study, the reported data shows that 39 people in the sham group and 77 people in the FAI insert group experienced at least one such event. Among more specific events recorded, 12 sham participants and 16 FAI participants experienced raised eye pressure; 21 sham and 60 FAI participants experienced new or worsening clouding of the lens (cataract); and 2 sham versus 11 FAI participants underwent a procedure related to cataract. No participants in either group were recorded in the final measurement category reported (which showed zero for both groups). The reported data shows a number of differences between the two groups across these measures, though it is important to note these are raw numbers only and do not on their own explain why differences occurred or what they mean for any individual. 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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NCT02251938 · results posted 12 February 2020

According to the results reported on ClinicalTrials.gov, this trial enrolled 60 people who received a single treatment called DE-109 440 μg (an eye injection). Of those 60 participants, 43 completed the study, while 17 did not finish. The trial was measuring several things related to eye health over 12 months, including how clearly participants could see (even with glasses or contact lenses), the fluid pressure inside the eye, the level of cloudiness or "haze" inside the eye, changes to two specific parts of the eye (the choroid and the macula), and how many participants needed additional treatments for their eye condition during the study. The reported data shows that, on average, participants' best-corrected vision (the sharpest vision possible with glasses or lenses) changed by 2.1 letters on a standard eye chart over 12 months, where a higher number means clearer vision. The fluid pressure inside the eye changed by an average of 0.3 mmHg (millimetres of mercury, a standard unit for eye pressure). The cloudiness score inside the eye changed by an average of -0.09 on a scale from 0 to 4, where a negative number indicates a small reduction in cloudiness. Regarding the need for extra treatment, the reported data shows that 9 out of the 60 participants required additional therapies for their eye condition during the study period. For the structural parts of the eye, the reported data shows that for the choroid (a layer at the back of the eye), 36 participants had findings reported as normal at both the start and end, while 4 shifted from normal to abnormal, 3 shifted from abnormal to normal, and none shifted from normal to normal in a different category — though some individual category figures were not fully detailed in the reported data. A similar breakdown was reported for the macula (the central part of the retina), with 20 participants recorded as normal throughout, 2 shifting from normal to abnormal, 6 shifting from abnormal to normal, and 15 remaining in an abnormal category throughout. 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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NCT02307513 · results posted 11 September 2019

According to the results reported on ClinicalTrials.gov, this trial enrolled 207 people with Behçet's syndrome — 103 in the placebo group and 104 in the apremilast group. The trial was measuring oral ulcers (mouth sores) associated with the condition over time. Participants first went through a 12-week placebo-controlled phase, where some received a dummy treatment and others received apremilast (30 mg twice daily), followed by a longer active treatment phase running to about 64 weeks. The reported data shows that for the main outcome — a measure of the total ulcer burden over the first 12 weeks (calculated by tracking the number of ulcers across multiple visits and expressed in "ulcer-days") — the placebo group recorded a value of 222.14 ulcer-days, while the apremilast group recorded 129.54 ulcer-days. For the secondary outcomes at week 12, the reported data shows that pain scores (measured on a 0–100 scale where higher means more pain) changed by −15.9 mm in the placebo group and −40.7 mm in the apremilast group, meaning both groups reported lower pain scores than at the start. On a disease activity questionnaire called the BSAS (scored 0–100, higher meaning more active disease), scores changed by −5.41 in the placebo group and −17.35 in the apremilast group. On another disease activity tool, the BDCAI (scored 0–12), scores changed by −0.4 and −0.9 respectively. Patients' own perception of disease activity (scored 1–7) changed by −0.7 and −1.7, and clinicians' perception of disease activity (also 1–7) changed by −0.7 and −1.6. In all of these measures, a negative number means the score went down from where it started. 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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NCT01358266 · results posted 16 July 2019

According to the results reported on ClinicalTrials.gov, this trial tested three different doses of an investigational eye treatment called DE-109 — a low dose (44 micrograms), a medium dose (440 micrograms), and a higher dose (880 micrograms). The trial had two stages: a "double-masked" phase (where neither participants nor researchers knew which dose was being given) and an open-label phase (where the dose was known). In the double-masked phase, 208 people started in the low-dose group, 208 in the medium-dose group, and 176 in the higher-dose group. The trial was measuring levels of "vitreous haze" — a cloudiness or haziness inside the eye that can affect vision — using a standardised scoring scale, where a score of 0 means no cloudiness at all. The reported data shows that the main result the trial was designed to measure was how many participants in each group had a vitreous haze score of zero (meaning no detectable cloudiness) at the five-month mark. According to the results reported on ClinicalTrials.gov, 28 participants in the low-dose group, 44 in the medium-dose group, and 27 in the higher-dose group reached that score of zero at month five. Additional measurements were also reported — for example, at month five, the number of participants who either reached a score of zero or showed a meaningful improvement of at least two steps on the scale was 43, 56, and 33 for the low, medium, and higher dose groups respectively. The reported data also shows that at month five, 84, 104, and 70 participants across the three groups had a score of zero or only the faintest trace of cloudiness. Similar counts were recorded at the six-month mark across all three measures, with the numbers varying across 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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NCT02049476 · results posted 5 July 2019

According to the results reported on ClinicalTrials.gov, this trial enrolled 20 participants, all of whom completed the study — none dropped out. Every participant received a dexamethasone pellet (a small implant that slowly releases a steroid medication into the eye). The trial was measuring eye inflammation, specifically looking at whether signs of inflammation inside the eye — such as cells in the front chamber of the eye, cloudiness in the gel-like interior, or inactive lesions at the back of the eye — were absent at 6 and 12 months after treatment. The reported data shows that at the 6-month mark (the main thing being measured), 12 out of 20 participants had no detectable signs of intraocular (inside-the-eye) inflammation. At 12 months (a secondary measurement), 13 out of 20 participants showed an absence of those inflammation signs. The trial also tracked eye pressure (the fluid pressure inside the eye, measured in mmHg). The reported data shows average eye pressure readings across visits of 13.2, 18.2, 14.6, 14.1, and 13.5 mmHg respectively — noting that the second reading was higher than the others. Regarding cataract development (clouding of the eye's lens), the reported data shows that across the earlier time points no participants needed cataract surgery, but by the later visits, 1 and then 3 eyes across the group had progressed to needing cataract surgery. 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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NCT01475643 · results posted 11 June 2019

According to the results reported on ClinicalTrials.gov, this trial compared two eye drop medicines — loteprednol etabonate and prednisolone acetate — in people who had inflammation inside the eye (specifically in a fluid-filled area at the front of the eye called the anterior chamber). A total of 107 people started the trial: 54 in the loteprednol etabonate group and 53 in the prednisolone acetate group. Of those, 40 and 43 people respectively completed the study. The reported data shows that the main thing being measured was the level of inflammation in the front of the eye, scored on a scale from 0 (no inflammation) to 4 (very severe inflammation). At the end of the study, the loteprednol etabonate group had an average score of 0.913, while the prednisolone acetate group had an average score of 0.783. A second measurement looked at something called "flare" — this refers to how much a beam of light scatters when shone into the eye, which is another way of detecting inflammation. That was also scored from 0 to 4. The reported data shows the loteprednol etabonate group had an average flare score of 0.192, compared with 0.341 for the prednisolone acetate 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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NCT02907814 · results posted 6 May 2019

According to the results reported on ClinicalTrials.gov, this trial (NCT02907814) enrolled 6 participants in the "Uveitis and Cataract Imaging Group" and no participants in the "Control" group. The study was looking at whether a type of eye scan called an OCT (Optical Coherence Tomography) scan — a non-invasive imaging test that uses light to take detailed pictures of the eye — could be used to spot inflammatory cells (white blood cells) in the front part of the eye in people with uveitis (inflammation of the eye) or cataracts. The reported data shows that, for the primary outcome — the number of participants in whom inflammatory cells could be identified using the OCT scan — all 6 participants in the imaging group had inflammatory cells identified. No measurements were reported for the Control group. Regarding the secondary outcome, which looked at whether changes in the density of those cells could be tracked over time using repeated OCT scans, the data was not reported for either group. It is also worth noting that, according to the results reported on ClinicalTrials.gov, none of the 6 participants who started the study were recorded as having completed it, though the reasons for this 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.

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NCT01829295 · results posted 26 April 2019

According to the results reported on ClinicalTrials.gov, this trial looked at two medicines — methotrexate and mycophenolate mofetil — used to control inflammation inside the eye (a condition sometimes called uveitis). The trial ran in two phases. In the first phase (0–6 months), 107 people were assigned to methotrexate and 109 to mycophenolate mofetil. Those whose inflammation was not adequately controlled at 6 months were then switched to the other medicine for a further 6 months. The trial measured whether participants reached a defined level of controlled eye inflammation while also being on low doses of steroid eye drops and steroid tablets. The reported data shows that at the 6-month mark, 64 out of 107 participants in the methotrexate group and 56 out of 109 in the mycophenolate mofetil group met the trial's definition of controlled inflammation. Among those who had met that target at 6 months and stayed on the same medicine, the reported data shows that 48 out of 64 in the methotrexate group and 40 out of 56 in the mycophenolate mofetil group still met that target at 12 months. For participants who had not met the target and were switched to the other medicine, the reported data shows that 20 out of 42 who switched to methotrexate and 7 out of 32 who switched to mycophenolate mofetil then met the inflammation-control target in their second six-month phase. 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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NCT01148225 · results posted 4 April 2019

According to the results reported on ClinicalTrials.gov, this trial enrolled 424 participants, all of whom received the medication adalimumab. Of those, 239 people completed the study and 185 did not finish. The trial was primarily focused on monitoring safety-related measurements — specifically, tracking any medical events that occurred during the study, checking blood test results for notable changes, and recording basic body readings such as heart rate, breathing rate, and temperature. The reported data shows that out of 424 participants, 398 experienced at least one adverse event (an unexpected medical occurrence during the study period), and 101 experienced a serious adverse event (a more significant medical occurrence, such as one requiring hospitalisation or considered life-threatening — though these are not necessarily caused by the medication). For blood test results, small numbers of participants showed values that were flagged as potentially significant: in blood cell counts, the reported figures were 3, 6, and 7 participants across different measures; in chemistry (organ-related) blood tests, the numbers ranged from 1 to 18 participants across eleven different measurements. For physical readings, the reported data shows that average heart rate changed by minus 1.0 beat per minute from the start to the end of the study, breathing rate changed by minus 0.1 breaths per minute, and body temperature changed by minus 0.03 degrees Celsius. Because the data as submitted does not include labels matching each specific blood test to its individual number, the full breakdown of which test corresponded to which figure was not able to be 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.

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NCT01960790 · results posted 22 March 2019

According to the results reported on ClinicalTrials.gov, this trial enrolled 473 participants, all of whom received the medication Humira® (adalimumab). The trial was conducted in people with Behcet's disease, a rare inflammatory condition, and followed participants over time — with 462 of the 473 completing the study and 11 not completing it. The trial was measuring adverse drug reactions (unexpected or unwanted responses to the medication) as its main focus, and also tracked a range of symptom-related outcomes as secondary measures, including gut symptoms, classic signs of Behcet's disease, and findings from internal camera examinations (endoscopies). The reported data shows that across the various categories of adverse drug reactions tracked, 47 participants experienced at least one such reaction, with smaller numbers — including 5, 6, 1, 3, 1, 3, 7, 1, 5, 9, and 20 participants — recorded across individual reaction sub-categories (the specific labels for each sub-category were not included in the submitted data). For the secondary outcomes, participants rated their gut symptoms on a scale from 0 (no symptoms) to 4 (symptoms critically affecting daily life) at multiple points during the study; the reported data shows participant counts spread across all five grades at each time point, though the precise time-point labels were not included in the submitted figures. Similarly, numbers of participants with Behcet's-specific symptoms — such as mouth ulcers, skin symptoms, eye symptoms, and joint problems — were recorded at weeks 52, 104, and 156, with the counts varying across those time points. For endoscopy findings, the reported data shows participant numbers distributed across different levels of change, though again the category labels were not 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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NCT01279954 · results posted 21 February 2019

According to the results reported on ClinicalTrials.gov, this trial enrolled 10 people in total, split into two groups of five. One group was planned to receive open-label abatacept (a medicine used to dampen the immune system) and then continue on a 10 mg/kg dose, while the other group was planned to continue on a 5 mg/kg dose. The trial was looking at adverse events (unwanted or harmful experiences during the study) as its main focus, as well as several secondary measures related to eye health — including changes in vision sharpness, whether participants were able to reduce their other immune-suppressing medicines, and whether signs of inflammation in the eye improved. Of the 10 people who started, 3 completed the study in one group and 1 in the other, meaning 7 people did not finish the trial. The reported data shows that for the primary outcome — the number of participants who experienced adverse events — zero participants were recorded across all three groups (those on 10 mg/kg, those on 5 mg/kg, and those in the open-label phase). For the secondary outcomes, all of which were measured at the 24-week mark when everyone was still on the same open-label treatment, the reported data shows that zero out of the participants showed an improvement of two or more lines in their best-corrected vision (a standard eye chart measure). Six participants were reported to have reduced their dose of corticosteroids or other immune-suppressing medicines by at least 50%. Four participants were reported to have shown a reduction in signs of eye inflammation based on clinical assessments. It is worth noting that this was a very small trial with only 10 participants, and a large proportion did not complete the study, which limits what can be drawn from these numbers. The reported data shows only what was observed and recorded in this specific group of people under the 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.

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NCT02374060 · results posted 5 November 2018

According to the results reported on ClinicalTrials.gov, this trial (NCT02374060) enrolled 192 people across three groups to compare three different corticosteroid treatments for macular oedema — a condition where the central part of the retina swells with fluid. The three groups were: a steroid injection around the outside of the eye (periocular triamcinolone 40mg, 65 participants), a steroid injection directly into the eye (intravitreal triamcinolone 4mg, 63 participants), and a slow-release steroid implant placed inside the eye (dexamethasone intravitreal implant, 64 participants). The main thing being measured was how much the thickness of the central retina changed over 8 weeks, compared to where each participant started. The reported data shows that at 8 weeks, retinal thickness as a proportion of each participant's starting thickness was 0.77 for the periocular injection group, 0.61 for the intravitreal injection group, and 0.54 for the implant group — where a lower number means greater reduction in thickness from baseline. For the secondary outcomes at 8 weeks, the proportion of eyes that achieved at least a 20% reduction in retinal thickness (or returned to a normal thickness) was reported as 0.41 for periocular, 0.79 for intravitreal injection, and 0.84 for the implant group. The proportion of eyes where retinal thickness returned fully to a normal level at 8 weeks was reported as 0.20, 0.47, and 0.61 respectively. The reported data also shows results at 24 weeks. Retinal thickness as a proportion of baseline was 0.68 (periocular), 0.64 (intravitreal injection), and 0.61 (implant). The proportion of eyes with at least a 20% thickness reduction at 24 weeks was 0.61, 0.73, and 0.74, while the proportion with full return to normal thickness at 24 weeks was 0.35, 0.36, and 0.41 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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NCT01526889 · results posted 31 October 2018

According to the results reported on ClinicalTrials.gov, this trial (NCT01526889) looked at a treatment called LFG316 compared to conventional therapy in people with uveitis, which is an inflammatory condition affecting the eye. A total of 25 people took part in the main treatment period — 18 in the LFG316 group and 7 in the conventional therapy group. Of these, 16 in the LFG316 group and all 7 in the conventional therapy group completed that period. A smaller follow-on extension period involved 5 participants from the LFG316 group only, of whom 4 completed it. The trial was measuring things like changes in eye cloudiness (called vitreous haze), visual acuity (sharpness of vision), inflammation inside the eye (measured by cells in the front chamber), and the presence of lesions at the back of the eye. The reported data shows that, for the main response measures during the treatment period, 3 out of 18 participants in the LFG316 group and 3 out of 7 in the conventional therapy group met at least one of the individual response criteria (such as meaningful improvements in eye cloudiness or vision). For the stricter measure of full remission — meaning very low inflammation scores, no lesions, and no need for immune-suppressing medicines — 2 participants in the LFG316 group and 0 in the conventional therapy group met those criteria. Regarding vision scores (measured by letters read on a standardised eye chart), the reported data shows average scores across time points ranging roughly from 65 to 80 letters in the LFG316 group and from 77 to 80 letters in the conventional therapy group. Small numbers of participants in both groups were reported to have macular swelling (fluid at the centre of the retina) and lesions at the back of the eye at various points during the trial. It is worth noting that this was a small trial, and the numbers of participants in each group were quite different, which limits how much can be read into any comparison between the two 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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NCT02769702 · results posted 1 October 2018

According to the results reported on ClinicalTrials.gov, this trial looked at a medication called Acthar (given at a dose of 80 IU) in people with uveitis — an inflammatory condition affecting the eye. The trial enrolled just 2 participants, and both of them completed the study. The main thing being measured was the level of cells in the front chamber of the eye (a sign of eye inflammation), rated on a scale from 0 to 4, where a higher number means more cells and more inflammation. A secondary measure looked at the amount of protein in the front chamber of the eye, also rated on the same 0 to 4 scale. The reported data shows that for the primary measure — the cell count in the front of the eye — the change from the starting point (baseline) was reported as 0.5 at one time point and 1.25 at another. These numbers represent how much the score shifted during the trial on the 0-to-4 scale. For the secondary measure — protein levels in the front of the eye — the reported data shows one time point value was not reported (listed as not available), and the other time point showed a change of 1.0 on the same scale. Because only 2 people took part in this trial, the numbers reflect a very small group of participants. It is worth noting that with only 2 participants, the reported figures are based on an extremely small sample, and the results should be understood in that 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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NCT03133767 · results posted 11 September 2018

According to the results reported on ClinicalTrials.gov, this trial enrolled 157 people who visited an emergency department — 79 received a fluid drip called Lactated Ringer's Solution and 78 received Normal Saline Solution (a standard salt-water drip). The trial was measuring how well patients felt they had recovered after receiving one of these two fluids, using a questionnaire called the Quality of Recovery-40 (QoR-40). This is a self-reported survey with 40 questions where patients rate how they are feeling across a range of areas; scores run from 40 (poorest recovery) to 200 (best recovery). Not everyone completed the study — 41 people in the Lactated Ringer's group and 53 in the Normal Saline group finished. The reported data shows that 24 hours after treatment, the average QoR-40 score for the Lactated Ringer's group was 166.8 out of 200, and for the Normal Saline group it was 164.4 out of 200. At an earlier time point — shortly after the fluid was given — the reported average scores were 152.6 for the Lactated Ringer's group and 141.6 for the Normal Saline group. These numbers reflect how patients rated their own recovery at those two points in time. The reported data also shows some follow-up information collected seven days later via text message. In the Lactated Ringer's group, 14 participants reported filling a prescription from the emergency department, 5 reported returning to the emergency department for the same problem, and 9 reported seeing another health provider for the same complaint. In the Normal Saline group, those numbers were 19, 7, and 7 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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NCT02764697 · results posted 2 July 2018

According to the results reported on ClinicalTrials.gov, this trial (NCT02764697) enrolled 5 participants, all of whom received injections of H.P. Acthar Subcutaneous Gel. The trial was looking at two things in people with a condition affecting the middle layer of the eye (intermediate uveitis): whether a measure of eye cloudiness called "vitreous haze" improved over 12 weeks, and whether swelling at the centre of the back of the eye (macular oedema) improved. Of the 5 people who started, 2 completed the trial and 3 did not finish. The reported data shows that for the haze measurement — graded on a scale from 0 (clear) to 4 (very cloudy), where a lower score is better — the results listed across the reported time points were 3 participants, then 1 participant, then 1 participant meeting the improvement target (either reaching grade 0 or dropping by 2 steps on the scale). For the second measure, which looked at whether the central thickness of the back of the eye reduced to below a certain level (300 microns, as measured by a scanning tool called OCT), the reported data shows 0 participants met this target at one time point and 5 participants at another — however, the data as submitted does not clearly label which time points these figures belong to, so these numbers should be interpreted with caution. It is worth noting that this was a very small trial with only 5 participants, and the data as reported to ClinicalTrials.gov has some gaps in how the time points are labelled. 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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NCT02482129 · results posted 28 August 2017

According to the results reported on ClinicalTrials.gov, this trial compared two treatments for eye inflammation — an investigational drug called LME636 and a steroid eye drop called dexamethasone. A total of 43 people were enrolled (32 in the LME636 group and 11 in the dexamethasone group), though slightly fewer actually received treatment (30 and 9 respectively). The trial measured several things related to eye health, including the level of inflammatory cells in the front of the eye, vision sharpness, fluid pressure inside the eye, and detailed eye examination findings. The reported data shows that by Day 15, 14 out of 30 participants in the LME636 group and 9 out of 9 participants in the dexamethasone group met the trial's definition of a "responder" — meaning their eye inflammation (measured by cell levels in the front of the eye) had reduced by at least two steps from where it started. For vision sharpness, measured by how many letters participants could read on a chart, scores across the visits ranged from around 70 to 75 letters for the LME636 group and around 77 to 79 letters for the dexamethasone group. Eye pressure readings across visits ranged from roughly 14 to 16 mmHg (millimetres of mercury, the unit used to measure eye pressure) for LME636, and roughly 15 to 17 mmHg for dexamethasone. For the detailed eye examinations, the reported data shows that more participants in the LME636 group showed increases (worsening) in certain slit-lamp and fundus (back-of-eye) findings compared with the dexamethasone group, though the specific numbers varied across the different features examined. The reported data also shows that when looking at eye pressure changes from the start of treatment to the last on-treatment check, most participants in both groups fell into the "no change" or small-change categories, with 25 LME636 participants and 8 dexamethasone participants recorded as having no meaningful change; small numbers in each group showed minor increases or decreases. 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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NCT00685399 · results posted 17 July 2017

According to the results reported on ClinicalTrials.gov, this trial involved participants across eight groups (called cohorts or arms), who were tested at different stages — a Treatment Period 1, a Treatment Period 2, and an Extension phase. In Treatment Period 1, 16 people started and 10 completed that phase. In Treatment Period 2, a total of 60 people started across six groups, with varying numbers completing. In the Extension phase, 28 people started and 21 completed. The trial was measuring the safety profile of the study drug (AIN457, also known as secukinumab) in people with uveitis (inflammation inside the eye), as well as looking at how many participants showed a meaningful improvement in their eye condition. The reported data shows that for the primary outcome — counting the number of participants who experienced unwanted health events (called adverse events), serious unwanted health events, or death — small numbers were recorded across the groups: one participant each in Cohort 3, Cohort 5, and Cohort 2 experienced adverse events, while no deaths were reported in the data provided. For the secondary outcomes, the reported data shows that a small number of participants across certain groups met the definition of a "responder" (meaning they showed at least one meaningful improvement in vision, eye inflammation, or were able to reduce their steroid medication) at Day 57: for example, one responder each was reported in Cohorts 2, 6 Arm 1, and 6 Arm 2, and three in Cohort 6 Arm 3. Similarly, small numbers of "complete responders" (those who were able to stop all steroid medications and maintain improvement) were reported across some groups. The reported data also notes that several other planned secondary outcomes — including measuring reductions in steroid use and rates of remission — were not formally analysed and no summary numbers were provided. According to the results reported on ClinicalTrials.gov, this was because the overall number of participants was too small and initial drug doses were too low to draw meaningful conclusions about how the dose related to outcomes. 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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NCT01900431 · results posted 20 June 2017

According to the results reported on ClinicalTrials.gov, this trial looked at a medicine called sarilumab (given as an injection every two weeks) compared to a placebo (an inactive injection) in people with a condition affecting the eye called uveitis — specifically a type involving cloudiness inside the eye. A total of 20 people started in the placebo group and 38 in the sarilumab group during the main part of the trial (Part A, running to Week 16). A separate open-label phase (Part C), where 21 participants received sarilumab without a comparison group, was also conducted. The trial was primarily measuring how many participants showed a meaningful reduction in eye cloudiness (called vitreous haze) or were able to reduce their steroid tablet dose below a certain level by Week 16. The reported data shows that in the main treatment period, 30.0% of participants in the placebo group and 46.1% in the sarilumab group met the primary goal of either a meaningful reduction in eye cloudiness or a lower steroid dose by Week 16. For the secondary measurements, the reported data shows that eye cloudiness scores changed by an average of −0.1 points (placebo) and −0.9 points (sarilumab) on a 9-step scale. A vision test score (measuring how many letters a person could read on a standardised chart) changed on average by +3.5 letters in the placebo group and +9.3 letters in the sarilumab group — where a higher number means more letters read. The thickness of the central part of the retina (a layer at the back of the eye) changed by an average of −8.9 microns in the placebo group and −35.4 microns (about −6.4%) in the sarilumab group. For a measure of cell activity at the front of the eye, 86.7% of the placebo group and 86.2% of the sarilumab group met the target response — nearly identical figures across 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.

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NCT01441076 · results posted 12 May 2017

According to the results reported on ClinicalTrials.gov, this trial looked at a medication called anakinra in people with Behçet's disease, a rare condition that can cause recurring mouth and genital sores, among other symptoms. Six participants enrolled in the single treatment group, four completed the trial, and two did not finish. The trial's main goal was to measure whether participants reached "clinical remission" — defined as having no mouth or genital ulcers at two consecutive monthly check-ups between months three and six of the study. The reported data shows that 2 out of the 6 participants who started the trial met that clinical remission definition. For the secondary measures — which were additional things the researchers tracked — the reported average scores at the end of the study were as follows: the Behçet's Disease Related Quality of Life scale (scored 0–30, where lower means better quality of life) recorded an average of 9.5; the Behçet's Syndrome Activity Scale (scored 0–100, where lower means less disease activity) recorded an average of 21.3; and the Behçet's Disease Current Activity Form (scored 0–12, where lower means less activity) recorded an average of 5. The reported data also shows an average of 0 genital ulcers and 0.5 oral ulcers observed by doctors at the time of evaluation. It is worth noting that this was a very small trial with only six participants, so the numbers above reflect a limited 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.

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NCT01154010 · results posted 4 May 2017

According to the results reported on ClinicalTrials.gov, this trial involved 18 people in total — 9 in a group using an active PEMF (pulsed electromagnetic field) device, and 9 using a placebo (inactive) version of the same device. PEMF is a type of therapy that uses electromagnetic pulses applied to the body. The trial was looking at whether using the active device alongside standard treatment made any difference to eye inflammation in people with a condition called anterior uveitis, which is swelling and irritation inside the front part of the eye. All 9 participants in the active device group finished the trial, while 8 of the 9 in the placebo group completed it. The reported data shows one primary outcome measure: the level of eye inflammation at day 7, scored on a scale from 0 to 4, where 0 means minimal inflammation and 4 means the most severe level. According to the results reported on ClinicalTrials.gov, the active device group had an average score of 0.625 at day 7, while the placebo device group had an average score of 1.444 at day 7. No other outcome measures were included in the submitted results data, so additional findings beyond this inflammation score were not reported. It is worth noting that this was a very small trial — fewer than 10 people in each group — and only one set of numbers was submitted. The reported data shows only what was measured and recorded in this particular 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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NCT01532570 · results posted 16 December 2016

According to the results reported on ClinicalTrials.gov, this trial (NCT01532570) looked at a treatment for Behçet's disease (BD), a rare condition that can cause inflammation in different parts of the body. A total of 18 people took part, divided into four groups based on which part of their body was affected: 11 with intestinal BD, 2 with acute neurological BD, 1 with chronic progressive neurological BD, and 4 with vascular BD. The main thing the trial was measuring was how many participants in each group showed a "complete response" by week 30 — meaning their symptoms had disappeared and scans and laboratory markers had improved compared to the start of the trial. The reported data shows that, at week 30, the complete response rate was 54.5% in the intestinal BD group (roughly 6 out of 11 people), 0% in the acute neurological BD group (neither of the 2 participants met the criteria), 100% in the chronic progressive neurological BD group (the 1 participant), and 100% in the vascular BD group (all 4 participants). At the earlier check-in point of week 14, the numbers were the same across all groups, and at week 54 they were similar — 60% for intestinal BD, 0% for acute neurological BD, and 100% for both the chronic progressive neurological and vascular BD groups. It is worth noting that the neurological and vascular groups were very small (1–4 people), so these percentages represent only a handful of individuals. The reported data also shows that participants rated their own symptoms on a scale of 0 (best) to 100 (worst) at several time points. Across all groups, the self-reported scores appeared to decrease over the course of the study — for example, the intestinal BD group started at around 55.5 and reached around 23.6 at the final measurement point, while the vascular BD group went from about 40.5 down to about 14.3. Imaging results for intestinal ulcers and brain MRI findings were also recorded, though the very small numbers in the neurological groups make these figures difficult to interpret broadly. Some imaging data points were not broken down in full detail 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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NCT01138657 · results posted 22 August 2016

According to the results reported on ClinicalTrials.gov, this trial (NCT01138657) enrolled 239 people in total — 120 received a placebo (an inactive dummy injection) and 119 received adalimumab, a medicine given by injection. The trial was looking at a condition called non-infectious uveitis, which is inflammation inside the eye. The main thing the trial measured was how long it took before a participant's eye condition got noticeably worse — an event the trial called "treatment failure" — starting from week 6 of the study. Several additional things were also measured, including changes in the amount of inflammation inside the eye, changes in vision sharpness, and changes in the thickness of the central part of the retina (the light-sensitive layer at the back of the eye). The reported data shows that, for the main group of participants (those recruited outside Japan), the median time — meaning the point at which half the participants in each group had experienced a treatment failure — was 3.0 months in the placebo group and 5.6 months in the adalimumab group. For the combined group that included Japanese participants as well, the figures were 3.0 months and 4.8 months respectively. For the secondary measures, the reported data shows that changes in eye inflammation scores (graded on standardised scales) and vision sharpness scores were numerically smaller in the adalimumab group than in the placebo group at the end of the study. The median time before signs of fluid build-up at the back of the eye (macular oedema) appeared was reported as 6.2 months (placebo) versus 11.1 months (adalimumab) in the main study group. The reported percentage increase in central retinal thickness was also numerically lower in the adalimumab group than in the placebo group across both study populations. 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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NCT01093846 · results posted 22 February 2016

According to the results reported on ClinicalTrials.gov, this trial (NCT01093846) was an extension study involving people with Behçet's disease who had certain types of eye inflammation (uveitis — swelling inside the eye). A total of 59 participants were enrolled across three groups: 19 received injections of AIN457 (secukinumab) every two weeks, 18 received it once a month, and 22 received a placebo (a dummy injection with no active medicine). The trial was designed to measure whether continuous treatment with AIN457 reduced the rate of recurring eye flare-ups compared to the placebo. The reported data shows that the study was ended early before it was completed. Because of this early termination, no results for the primary outcome — the rate of recurring eye flare-ups — were ever analysed or reported. The ClinicalTrials.gov record notes that only safety-related information (records of side effects and adverse events) was collected and summarised, but those figures are not included in the outcomes section of the structured results. The number of participants who completed the study was very low, with only one person in the placebo group recorded as having fully completed it, and none in either AIN457 group. The reported data shows no efficacy (treatment effect) numbers are available from this trial due to its early closure. Any safety data that was gathered is noted as existing separately but was not provided in the structured results submitted 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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NCT01090310 · results posted 14 January 2016

According to the results reported on ClinicalTrials.gov, this trial looked at a medicine called AIN457 (also known as secukinumab) for people with a type of eye inflammation affecting the middle or back of the eye (uveitis). A total of 125 people took part in the core part of the study, split across four groups: one group received AIN457 300 mg every two weeks (29 people), one received AIN457 300 mg every four weeks (31 people), one received AIN457 150 mg every four weeks (31 people), and one received a placebo — a dummy treatment with no active ingredient (34 people). A smaller group of 70 people then continued into an extension phase of the study. The trial was mainly measuring how long it took before participants experienced a return of their eye inflammation after the study began. The reported data shows that for the main (primary) outcome — the estimated time until eye inflammation returned — no numerical values were reported for any of the four groups; this figure was listed as "NA" (not available) in the submitted data. For the secondary outcomes, the data shows that the number of participants whose inflammation returned during the combined core and extension studies varied across groups: 8 out of 29 in the highest-dose fortnightly group, 11 out of 31 in the monthly 300 mg group, 10 out of 31 in the monthly 150 mg group, and 11 out of 34 in the placebo group. A secondary measure looked at changes in visual acuity (sharpness of vision, scored out of 100 letters) — the reported data shows average changes of +9 letters for the fortnightly 300 mg group, +16 letters for the 150 mg monthly group, and +5 letters for the placebo group; the figure for the 300 mg monthly group was not reported. A score measuring the use of other immune-suppressing medicines also showed changes, but data was only reported for two of the three AIN457 groups and the placebo 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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NCT01232920 · results posted 5 January 2016

According to the results reported on ClinicalTrials.gov, this trial enrolled 80 people in total — 41 in the methotrexate group and 39 in the mycophenolate mofetil group. Both are medicines sometimes used to calm inflammation in the eye. The trial was measuring whether participants could get their eye inflammation under control while also reducing their steroid (prednisone) use to a low level, and keeping it there over at least two visits roughly a month apart. By the end of the study, 35 people in the methotrexate group and 32 in the mycophenolate mofetil group had completed the trial. The reported data shows that, for the main goal ("treatment success" as defined above), 24 out of 41 participants in the methotrexate group and 15 out of 39 in the mycophenolate mofetil group met that target. For one secondary measure — how long it took for inflammation to come under control — the reported figures were an average of 139 days for the methotrexate group and 124 days for the mycophenolate mofetil group. The trial also tracked changes in best corrected vision (measured on a technical scale called LogMAR, where a lower number means better vision); the reported change from the start of the trial was −0.26 for methotrexate and −0.19 for mycophenolate mofetil. Finally, the trial looked at how many eyes had swelling at the back of the eye (macular oedema) resolve; the reported data shows figures of 22 and 17 eyes in the methotrexate group, and 13 and 7 eyes in the mycophenolate mofetil group, though the data as submitted does not clearly label what each pair of numbers refers to, so those figures should be interpreted 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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NCT01032915 · results posted 5 November 2015

According to the results reported on ClinicalTrials.gov, this trial looked at a medicine called AIN457 (also known as secukinumab) given by injection under the skin, compared to a dummy injection (placebo), in people with certain types of eye inflammation affecting the middle or back of the eye. A total of 125 people took part across four groups: 29 received AIN457 300 mg every two weeks, 31 received AIN457 300 mg every four weeks, 31 received AIN457 150 mg every four weeks, and 34 received the placebo every two weeks. The main thing the trial was measuring was how long it took before eye inflammation came back after the start of the study. The reported data shows that for the main measure — time until eye inflammation returned — a specific number of days was only reported for one of the four groups: the group receiving AIN457 150 mg every four weeks, where the figure was 178 days. For the other three groups, including the placebo group, this figure was not reported in the submitted data. For the secondary measures, all four groups showed a reduction in the score used to measure how much other immune-suppressing medication participants were taking (a lower score is described as a better outcome): the two-weekly 300 mg group reduced by 2.55 points, the four-weekly 300 mg group by 2.81 points, the four-weekly 150 mg group by 2.92 points, and the placebo group by 2.13 points. When it came to the cloudiness inside the eye (called vitreous haze, scored on a scale of 0 to 4), the reported average change from the start of the study to 24 weeks was very small across all groups: 0.02 for each of the three AIN457 groups and 0.2 for the placebo group. Vision, measured by a standard letter-reading test, showed small average improvements across all groups, ranging from 1.4 letters in the placebo group to 2.9 letters in the two-weekly 300 mg 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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NCT01095250 · results posted 3 November 2015

According to the results reported on ClinicalTrials.gov, this trial enrolled 31 people in total across four groups: 8 people received AIN457 (secukinumab) at 300 mg every 2 weeks, 10 received 300 mg every 4 weeks, 8 received 150 mg every 4 weeks, and 5 received a placebo (an inactive injection). The trial was designed to test whether AIN457, given as an injection under the skin, could reduce eye inflammation in people with a condition called non-infectious uveitis — specifically those with Behçet's disease. The main thing researchers planned to measure was the change in a score describing cloudiness inside the eye (called "vitreous haze") from the start of the trial to 28 weeks. The reported data shows that no outcome measure numbers — for either the primary measure or any of the six secondary measures (such as changes in vision, quality of life, or eye inflammation scores) — were provided. According to the results reported on ClinicalTrials.gov, none of the participants reached the point in the study where the main measurement was due to be taken. As a result, the trial was stopped early because of what the sponsor described as a low likelihood of the study achieving a meaningful result. Because participants did not reach the required stage of the trial, the sponsor stated that no meaningful data could be reported for any of the planned outcome measures. The reported data therefore contains no numerical results for any of the outcomes that were originally planned to be measured. All 31 participants who started the trial are recorded as not having completed it, and the reasons relate to the early termination of the study rather than individual dropouts. No outcome figures are available 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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NCT00995709 · results posted 31 August 2015

According to the results reported on ClinicalTrials.gov, this trial involved 118 people in total — 39 received the study drug (called AIN457C, also known as secukinumab) every two weeks, 40 received it once a month, and 39 received a dummy (placebo) treatment. The trial ran for 24 weeks and was looking at a condition called Behçet's disease, which can cause repeated flare-ups of inflammation at the back of the eye. The main thing the trial measured was how often those eye flare-ups happened during the 24-week period. It also looked at secondary measures including steroid medication use, retinal thickness (a scan measuring the layers at the back of the eye), quality of life, and overall disease activity. Not all participants finished the study — 32, 31, and 34 completed it in the three groups respectively. The reported data shows that for the primary outcome — the rate of eye flare-ups over 24 weeks — the every-two-weeks group and the placebo group both recorded a rate of 7.7 flare-ups, while the monthly group recorded a rate of 11.5. In terms of how many participants experienced flare-ups, the numbers were broadly similar across all three groups. For the secondary outcomes, the reported data shows changes in steroid medication scores, retinal thickness scans, and disease activity scores across all groups. For retinal thickness (measured in micrometres), the every-two-weeks group showed an average reduction of 26.5, the monthly group showed a small increase of 3.6, and the placebo group showed a reduction of 49.4. For overall Behçet's disease activity, small reductions from baseline were recorded in all three groups (−1.3, −1.7, and −1.1 respectively). Quality of life scores and steroid use data were also reported across the groups, though interpreting what those differences mean in a clinical sense was not 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.

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NCT00866359 · results posted 27 August 2014

According to the results reported on ClinicalTrials.gov, this trial enrolled 111 adults in total — 56 were assigned to receive a placebo (an inactive tablet) twice daily, and 55 were assigned to receive apremilast 30 mg twice daily. The trial was studying Behçet's syndrome, a condition that can cause painful sores in the mouth and on the genitals. The main thing the trial set out to measure was the number of oral (mouth) ulcers each person had at Day 85 (roughly 12 weeks into treatment). After this first phase, participants who had been on placebo were switched to apremilast for a further 12-week extension phase, and then all participants were followed up observationally. The reported data shows that at Day 85, people in the placebo group had an average of 2.0 mouth ulcers, while people in the apremilast group had an average of 0.4 mouth ulcers. For pain from mouth ulcers, participants rated their pain on a scale of 0 to 100 (where 0 means no pain and 100 means the worst pain imaginable) — the placebo group reported an average score of 36.7, compared with 9.9 in the apremilast group. The trial also tracked ulcer counts over the entire 85-day period (using a running total measure called "area under the curve"): the placebo group's total was reported as 157.82, compared with 67.74 for the apremilast group. Regarding genital ulcer pain scores and genital ulcer counts over time, the reported data shows these were not analysed or the results were not submitted. A separate measure noted that 100% of participants in the apremilast group were free of active genital ulcers at Day 85, compared with 50% in the placebo 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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NCT00826618 · results posted 26 August 2014

According to the results reported on ClinicalTrials.gov, this trial enrolled 6 participants, all of whom received a treatment called ranibizumab, given as an injection into the eye. The trial was measuring changes in vision over 12 months in people with a particular eye condition. Five of the six participants completed the study, and one did not finish. The main thing the trial was measuring was how much participants' vision changed over 12 months, using a standard eye chart test called the ETDRS chart (a chart used to measure how many letters a person can read correctly). The reported data shows that, on average, participants were able to read 12.2 more letters on the chart at 12 months compared to when they started the trial. The trial also set out to measure a number of other things — including the proportion of participants whose vision improved by 15 letters or more, changes in the thickness of a part of the eye called the fovea, and any unwanted events that occurred — however, no numerical results for these secondary measures were reported in the ClinicalTrials.gov data. It is worth noting that this was a very small trial with only 6 participants, and the secondary outcome data was not reported, so the picture of what was measured is incomplete. 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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NCT00889421 · results posted 8 July 2014

According to the results reported on ClinicalTrials.gov, this trial (NCT00889421) enrolled 3 participants in a single treatment group. The study was investigating a treatment for eye inflammation (uveitis), and was looking at several things: whether vision improved by a meaningful amount, whether participants could reduce their use of steroids or other immune-suppressing medicines, whether signs of inflammation in the eye settled down, and whether fluid build-up at the back of the eye (the macula) decreased. A secondary aim was to track any unwanted or unexpected health events that occurred during the study. The reported data shows that none of the 3 participants completed the trial — all 3 withdrew or were otherwise recorded as "not completed." Because no participants finished the study, no results were recorded for any of the primary outcome measures (vision improvement, steroid reduction, inflammation control, or fluid reduction), and no results were recorded for the secondary outcome measure tracking adverse events either. The data was not reported for any of these measures. It is not possible to draw any conclusions about the treatment from this trial, as the study did not reach completion and no outcome data 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.

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NCT01314417 · results posted 26 September 2013

According to the results reported on ClinicalTrials.gov, this trial enrolled just 2 participants, both of whom completed the study. The trial was looking at whether a medicine called methotrexate could reduce swelling at the back of the eye (specifically, swelling in a part of the eye called the macula). The main question the trial was designed to answer was how many participants showed a meaningful reduction in that swelling within 12 weeks of starting treatment. The reported data shows that both of the 2 participants met the trial's definition of "treatment success" within 12 weeks — meaning both showed at least a 20% reduction in the measured eye swelling, which was the threshold the researchers set as clinically meaningful. The reported data also shows changes in excess retinal (back-of-the-eye) thickening at several points across the study: at 4 weeks the average change from the starting measurement was 7.2%, at 8 weeks it was 9.9%, at 12 weeks it was 6.1%, at 16 weeks it was 13.6%, and at 20 weeks it was 4.9%. These figures represent the percentage change in swelling compared to where each participant started, though it is important to note these numbers come from only 2 people. It is worth noting that with only 2 participants, this trial was extremely small — far smaller than most clinical trials — and the results reported here are therefore very limited in what they can tell us broadly. 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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NCT01201798 · results posted 15 November 2012

According to the results reported on ClinicalTrials.gov, this trial enrolled 110 people in total — 56 in the Durezol group and 54 in the Pred Forte group. The trial was comparing two eye drop medicines used to treat inflammation inside the eye (a condition involving swelling and irritation in the front chamber of the eye). The main thing being measured was the change in the level of inflammatory cells visible in the front part of the eye, assessed by a doctor using a special lamp and graded on a scale from 0 (very few or no cells) to 4 (a very high number of cells). By the end of the study, 47 people in the Durezol group and 39 in the Pred Forte group had completed the trial. The reported data shows that at the start of the study, both groups had an average cell grade of 2.6 out of 4. By day 14 — the main measurement point — the Durezol group's average score had dropped by 2.2 points, while the Pred Forte group's average score had dropped by 2.0 points. The reported data also shows changes measured at earlier time points, with both groups showing a gradual reduction in their scores across the visits. For a separate measure — the proportion of participants whose cell count reached zero — the reported figures at day 14 were 73.9% in the Durezol group and 48.9% in the Pred Forte group. A measure combining near-zero cell counts and no visible protein leakage showed 82.6% for Durezol and 76.6% for Pred Forte at day 14. Changes in protein leakage (called "flare") were also tracked, and both groups showed similar reductions across all time points, reaching an average drop of around 2.0 points by the final 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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NCT01376362 · results posted 8 October 2012

According to the results reported on ClinicalTrials.gov, this trial enrolled 5 participants, all of whom completed the study — none dropped out. All participants received a treatment called Interferon Gamma-1b. The trial was measuring changes in the thickness of the central part of the retina (the macula, a small area at the back of the eye responsible for sharp, central vision) in two eyes: the "study eye" (the eye being treated) and the "fellow eye" (the other eye). These measurements were taken using a scanning technique called OCT, which creates detailed images of the eye's layers without any cuts or needles. Measurements were taken at the start of the trial (baseline) and again at one week and two weeks. The reported data shows that in the study eye, the central macular thickness decreased by an average of 38.60 micrometres (very small units of measurement) by week one, and by 47.40 micrometres by week two, compared to the starting measurement. In the fellow eye — which was not the focus of treatment — the reported data shows the thickness actually increased by an average of 12.00 micrometres at week one and 30.20 micrometres at week two. For the overall volume of the macula (measured in cubic millimetres), the study eye showed a very small average decrease of 0.02 cubic millimetres at week one, while the fellow eye showed a small average increase of 0.14 cubic millimetres at week one. Changes in macular volume at week two were not reported in the data. It is worth noting that with only 5 participants, this was a very small study, and no comparison group (such as a placebo group) was included 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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NCT00498355 · results posted 21 September 2012

According to the results reported on ClinicalTrials.gov, this trial enrolled 7 participants, all of whom received a treatment called ranibizumab (given as an injection into the eye) for a condition called macular oedema — a swelling at the centre of the retina that can affect vision. Six of the seven participants completed the trial; one did not finish. The trial was measuring changes in vision sharpness and retinal thickness over time, as well as counting any unwanted events that occurred. The reported data shows that, on average, participants' best corrected vision (that is, vision measured with the most suitable glasses or lenses in place, using a standardised letter chart) improved by 13 letters from the starting point to the 3-month mark. When looking at the longer period from 6 to 12 months, the reported median change (the middle value across participants) in vision was a decrease of 2 letters. The reported data also shows changes in the thickness of the central retina, measured in microns (millionths of a metre): the thickness decreased by 267 microns at 7 days, 356 microns at 3 months, 354 microns at 6 months, 243 microns at 9 months, and 388 microns at 12 months — all reductions from the starting measurement. The reported data shows that zero episodes of a specific type of eye inflammation (called a uveitis flare, meaning significant inflammation inside the eye) were recorded. Four unwanted events — covering both eye-related and non-eye-related occurrences — were reported in total, though a breakdown of what those events were is not 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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NCT01194674 · results posted 14 August 2012

According to the results reported on ClinicalTrials.gov, this trial looked at a treatment called Microplasmin and involved only 2 participants, both of whom completed the study. The trial was originally designed to measure both any unwanted health events (called adverse events) that occurred, and changes in the eye — specifically the thickness of a part of the retina called the macula, and whether a particular layer at the back of the eye separated as intended. The study closed earlier than planned because not enough people enrolled. The reported data shows that across the 2 participants, a total of 4 adverse events (unexpected or unwanted health occurrences) were recorded. Of those, 1 was related to the eye and 3 were not eye-related. Importantly, the reported data shows that 0 severe adverse events were recorded. No numbers are available for the two secondary outcomes — changes in retinal thickness and the separation of the layer at the back of the eye — because the researchers stated there was insufficient data to report these results due to the early closure of the trial. It is worth noting that with only 2 participants completing this study, the reported figures represent an extremely small snapshot and cannot be used to draw broad conclusions. The reported data shows only what was observed in this very limited group 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.

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NCT00132691 · results posted 30 July 2012

According to the results reported on ClinicalTrials.gov, this trial enrolled 255 people in total — 129 in the group that received a fluocinolone acetonide intraocular implant (a small device surgically placed inside the eye to slowly release medicine) and 126 in the group that received standard systemic treatment (medicines taken by mouth or injection that work throughout the whole body). The trial was measuring how each approach affected vision and eye health in people with uveitis (a condition involving inflammation inside the eye) over 24 months. The reported data shows that, for the primary outcome — change in the number of letters read on a standard eye chart — the implant group improved by an average of 6.0 letters and the systemic treatment group improved by an average of 3.2 letters from the start of the trial. Note that the researchers considered a change of 7.5 letters to be clinically meaningful, so neither group's average change reached that threshold. For secondary outcomes, the reported data shows that 22% of eyes in the implant group had macular swelling (fluid build-up at the back of the eye) compared with 30% in the systemic treatment group, and 12% of eyes in the implant group showed signs of active inflammation compared with 29% in the systemic treatment group. However, the reported data also shows notably higher rates of elevated eye pressure in the implant group across all three eye pressure measures: for example, 32.8% of implant-group eyes reached a high pressure reading (≥30 mmHg, a unit used to measure pressure in the eye) compared with 6.3% in the systemic treatment group, and similar patterns were seen at lower pressure thresholds and for large pressure rises 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.

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NCT00525902 · results posted 9 April 2012

According to the results reported on ClinicalTrials.gov, this trial involved 31 people who received a medicine called adalimumab. The trial was looking at how the medicine affected a condition involving inflammation inside the eye. Researchers tracked participants over time — 30 people reached the 10-week point, and 12 reached the 50-week point. The study was measuring a combined set of goals, where a participant was considered to have met the target if they improved in at least one of four areas (such as better vision, reduced need for other medicines, better control of eye inflammation, or reduced fluid and inflammation visible on eye scans) without getting noticeably worse in any of the others. The reported data shows that, out of the 31 people who started the trial, 21 participants met at least one of those improvement goals at some point during the study. The reported data also shows that 12 participants met those goals at the 50-week stage. No comparison group (such as a placebo or dummy treatment group) was included in the data submitted, so these numbers reflect only the group who received adalimumab. Some figures — such as the exact breakdown of which specific improvement goals were met — were not 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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NCT00476593 · results posted 22 June 2011

According to the results reported on ClinicalTrials.gov, this trial involved a total of 218 participants across four groups: 32 people who received diclofenac eye drops, 19 who received dexamethasone eye drops, 38 patients with a condition called anterior uveitis (inflammation inside the front part of the eye), and 129 healthy volunteers. The trial was measuring the thickness of the macula — a small but important area at the back of the eye — using a scanning device called an OCT (optical coherence tomography). The researchers looked at whether factors like age, sex, having had children, use of hormonal therapies, or the type of anti-inflammatory eye drops used were linked to differences in macula thickness. Not everyone who started the trial completed it: 22 diclofenac participants, 17 dexamethasone participants, 30 uveitis patients, and 107 healthy volunteers finished the study. The reported data shows that average macula thickness, measured in microns (a micron is one-thousandth of a millimetre), was 268 microns in the diclofenac group, 272 microns in the dexamethasone group, 276 microns in the anterior uveitis patients, and 267 microns in the healthy volunteers. These are the figures as submitted to ClinicalTrials.gov. It is worth noting that no additional breakdown by age, sex, or other factors was included in the structured results data provided, so those detailed findings were not reported in this dataset. 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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NCT00333814 · results posted 14 April 2011

According to the results reported on ClinicalTrials.gov, this trial involved 229 people in total, split across three groups: one group received a low dose (350 micrograms) of a medicine called dexamethasone injected into the eye, one group received a higher dose (700 micrograms), and one group received a sham (fake) procedure as a comparison. The trial was looking at a condition causing inflammation inside the eye, and the main thing being measured was how many people had no detectable eye inflammation (called a vitreous haze score of zero) at eight weeks after treatment. The reported data shows that at the eight-week mark, 35.5% of people in the low-dose group and 46.8% of people in the higher-dose group had a vitreous haze score of zero, meaning no detectable inflammation was recorded. In the sham group, 11.8% reached that same score. The reported data also shows that when it came to vision improvement — specifically, reading at least 15 more letters on an eye chart than at the start — 39.5% of the low-dose group and 42.9% of the higher-dose group reached that level, compared with 6.6% in the sham group. A separate quality-of-life questionnaire (a survey about how well people could carry out everyday visual tasks, scored from 0 to 100) showed that a meaningful improvement of at least 10 points was reported by 40.8% of the low-dose group and 50.7% of the higher-dose group, versus 15.9% of 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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NCT00280826 · results posted 27 January 2011

According to the results reported on ClinicalTrials.gov, this trial looked at a medication called efalizumab and involved 6 participants in total. All 6 completed the study — none dropped out. The trial was measuring two main things: first, whether participants experienced any notable side effects, health problems, or infections while taking the medication; and second, whether there were any changes in a specific eye condition called cystoid macular oedema (a type of swelling in the central part of the eye) and in participants' vision over 16 weeks. The reported data shows that all 6 participants had systemic toxicities, adverse events, or infections recorded during the study — though the data does not break down what those events were or how serious they were. For the eye swelling measurements (taken using a scanning technology called optical coherence tomography, or OCT, which produces detailed images of the eye), the reported average swelling was 128 microns in the worse-seeing eye and 57 microns in the better-seeing eye. These figures represent the measurements at the time reported, but the data does not include a starting (baseline) figure for comparison, so the direction of change in swelling is not reported here. The reported data shows that vision — measured by how many letters participants could read on a standardised eye chart — changed by an average of 6.7 letters in the worse-seeing eye and 1.7 letters in the better-seeing eye over the 16-week period. Whether these changes represent an improvement or a worsening is not explicitly stated in the submitted data. Given that only 6 people took part, this was a very small study, and the numbers reflect only this particular group of 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.

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NCT00130637 · results posted 29 September 2010

According to the results reported on ClinicalTrials.gov, this trial looked at a medicine called daclizumab in people with a type of eye inflammation linked to juvenile idiopathic arthritis (JIA) — a condition where the joints and sometimes the eyes become inflamed in children. Six participants were enrolled in the study overall. Three participants completed the trial, and three did not finish. The trial was measuring two things: whether daclizumab could reduce eye inflammation by a meaningful amount, and whether any serious unwanted medical events (known as serious adverse events) occurred while taking the medicine. The reported data shows that, out of the six participants, five were reported to have achieved a significant reduction in their eye inflammation — specifically, a drop of at least two steps on a scale used to measure inflammation in the front of the eye (where 0 means almost no inflammation and 4+ means very heavy inflammation). This reduction also had to occur while the participant was using eye drop steroids fewer than three times a day. Regarding safety, the reported data shows that one out of the six participants experienced a serious adverse event during the study, though the specific nature of that event was not detailed in the data provided here. It is worth noting that this was a very small trial with only six participants, so the numbers are based on a limited 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.

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NCT00483184 · results posted 16 June 2009

According to the results reported on ClinicalTrials.gov, this trial (NCT00483184) enrolled a total of 84 participants across three groups: Group 1 had 27 people, Group 2 had 31 people, and Group 3 had 26 people. The trial was measuring responses related to oral ulcers (mouth sores), specifically looking at whether participants experienced a meaningful and lasting reduction in the number of ulcers over time. By the end of the study, 72 of the 84 participants completed the trial — 22 in Group 1, 27 in Group 2, and 23 in Group 3. The reported data shows that the main (primary) outcome measured how many participants in each group achieved a "sustained response," which the trial defined as a 75% or greater reduction in total oral ulcer count across at least three consecutive visits. According to the results reported on ClinicalTrials.gov, 13 participants in Group 1, 10 in Group 2, and 12 in Group 3 met this definition of sustained response. For the secondary outcomes — which were listed as including time to first response, recurrence of ulcers, time to recurrence, pain linked to mouth sores, general wellbeing, and safety — the reported data does not include any numerical results, so those figures 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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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.