Trial 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
According to the results reported on ClinicalTrials.gov, this trial (NCT04864834) enrolled 485 adults in total — 245 in the SOK583A1 group and 240 in the Eylea EU group. Both medicines are versions of aflibercept (40 mg/mL), an injection used in the eye for a condition called neovascular age-related macular degeneration (nAMD), which affects central vision. The trial was designed to compare the two treatments across a range of measures, including vision sharpness, changes in the layers of the eye, and the body's immune response to the medicine. Most participants completed the study (216 in the SOK583A1 group and 215 in the Eylea EU group). The reported data shows that the main thing being measured was the change in how many letters participants could read on a standardised eye chart (called an ETDRS chart) between the start of the study and week 8. In the SOK583A1 group, the average improvement was 6.5 letters; in the Eylea EU group it was 6.8 letters. For secondary measures, the reported data shows changes in the thickness of a specific layer at the back of the eye (central subfield thickness) at several time points — both groups showed reductions across all measured time points, ranging from around 100 to 188 micrometres in the SOK583A1 group and 99 to 173 micrometres in the Eylea EU group. Changes in a measure of abnormal blood vessel size in the eye were also recorded and appeared similar between groups. At weeks 24 and 52, the average letter-score improvements were 6.9 and 6.4 (SOK583A1) versus 7.4 and 7.7 (Eylea EU). Regarding the immune response (the body producing antibodies against the medicine), 2 participants in the SOK583A1 group and 6 in the Eylea EU group were reported to have developed such antibodies, while 232 and 225 respectively did not. The number of participants who experienced adverse events (unwanted health events recorded during the study) was also reported: 84 in the SOK583A1 group and 78 in the Eylea EU group had eye-related events; 55 and 51 had events elsewhere in the body; and 141 in each group had any adverse event of any kind over 52 weeks. The trial did not report what proportion of these events were considered serious or related to treatment in the structured data provided here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View full results on ClinicalTrials.gov ↗
These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.
Phase 3 Macular Degeneration Trial, Completed
Who may be able to join
AI generated eligibility 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
Who might be able to join this trial:
- You are willing to sign a consent form before taking part in the study
- You are 50 years of age or older at the time of screening
- You have never received any anti-VEGF treatment (a type of eye injection therapy) in either eye or anywhere else in your body
- Your eye has been diagnosed with active abnormal blood vessel growth (called CNV) related to age-related macular degeneration (AMD), affecting the central part of your vision, confirmed by imaging tests
- The abnormal blood vessel area makes up more than half of the total problem area in your eye, as confirmed by imaging
- Your vision in the study eye falls within a specific range on a standardised eye chart test (not too good and not too poor — confirm with trial site)
- You are willing and able to attend all study appointments and likely to complete the full study
- Your eyes are clear enough and your pupils can dilate enough to allow good quality photographs to be taken
Who may not be able to join:
- You have ever received anti-VEGF injections or any other investigational treatment in either eye at any time before the study starts
- You have previously received any approved treatment for wet AMD (other than vitamins or dietary supplements) in the study eye
- The abnormal blood vessel growth in your eye is caused by something other than AMD, such as severe short-sightedness, certain eye infections, or other specific eye conditions
- You have any active or suspected infection or inflammation in or around either eye at the time of screening or at the start of the study
- More than half of the problem area in your study eye is made up of scar tissue or damaged tissue
- There is a large amount of bleeding under the retina in your study eye (confirm exact thresholds with trial site)
- There is a tear or rip in a specific layer of your eye (the retinal pigment epithelium) in the study eye
- You currently have or have recently had bleeding inside the eye (vitreous hemorrhage) within 4 weeks before the study starts
- You have had eye surgery (including cataract surgery) within 90 days before the study starts, or certain other eye surgeries at any point in the past, such as retinal detachment surgery, previous laser treatments, or corneal transplants
- You are allergic or sensitive to any of the study medications or to fluorescein dye used in eye imaging
- You have uncontrolled glaucoma (high pressure in the eye) even while on medication
- The lens is missing from your study eye in a way that does not meet specific exceptions (confirm with trial site)
- You have used steroid medications in or around the study eye within the past 6 months, or steroid eye drops for 30 or more days in a row within the past 90 days
- You have had radiation treatment near your eye in the past
- You have other eye conditions in the study eye that could affect your response to treatment or make results difficult to interpret
- Your other (non-study) eye has very poor vision below a certain level, unless it is caused by a treatable condition like a cataract
- You have a condition called scleromalacia (thinning of the white of the eye) in either eye
- You have previously received anti-VEGF treatment anywhere in your body (systemically)
- You have taken steroid tablets or injections for 30 or more days in a row within the past 90 days (unless on a low, stable long-term dose — confirm with trial site)
- You have uncontrolled high blood pressure at the time of screening
- You have had a stroke or heart attack in the 6 months before the study starts
- You have taken part in another clinical trial involving an experimental drug or device recently (within 30 days or longer, depending on the drug — confirm with trial site)
- You have a current infection or had an active infection within 2 weeks before screening
- You have a serious, uncontrolled medical condition affecting major organs or body systems that your doctor feels puts you at too much risk
- You have a medical history that your doctor believes could make it unsafe for you to take part or complete the study
- You are pregnant, breastfeeding, or able to become pregnant and not using a highly effective form of contraception during the study and for 3 months after finishing the study medication
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Australian sites
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
6 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Best-Corrected Visual Acuity (BCVA) Will be Assessed Using the ETDRS Testing Charts at an Initial Distance of 4 Meters. The Change From Baseline in BCVA in Letters is Defined as Difference Between BCVA Score Between Week 8 and Baseline.
Can't join this trial?
Data last synced from ClinicalTrials.gov: 23 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.