EYE103 for Macular Degeneration
(Super Tuscan Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called EYE103 for individuals with specific eye conditions. It focuses on neovascular age-related macular degeneration, where abnormal blood vessels grow under the retina, and macular edema from branch retinal vein occlusion, which involves swelling in the eye due to a blocked vein. Participants will receive either a low or high dose of EYE103 through eye injections to determine which is more effective. Those recently diagnosed with these conditions and who have not started other treatments might be suitable candidates. As a Phase 2 trial, the research measures the treatment's effectiveness in an initial, smaller group of participants.
Do I need to stop my current medications for the trial?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are using drugs with known retinal toxicity, like Hydroxychloroquine, pentosan polysulfate sodium, and amiodarone.
Is there any evidence suggesting that EYE103 is likely to be safe for humans?
Research has shown that EYE103 was well-tolerated in past studies. Both high and low doses of EYE103 demonstrated promising safety results in conditions like diabetic macular edema (DME). Patients generally did not experience major side effects, and the treatment was well-received.
When combined with Aflibercept, a drug already approved for some eye conditions, EYE103 also maintained a good safety record. Aflibercept is known for its safety and effectiveness, which adds confidence to its use with EYE103.
Since this trial is in Phase 2, earlier studies have already indicated some safety. While individual experiences can differ, current data suggests that EYE103, alone or with Aflibercept, is likely safe for most participants.12345Why do researchers think this study treatment might be promising for macular degeneration?
EYE103 is unique because it offers a new approach to treating macular degeneration and branch retinal vein occlusion (BRVO). Unlike current treatments, which often involve repeated injections of drugs like aflibercept or ranibizumab, EYE103 can be used in combination with existing therapies or as a standalone treatment in different dosing options. Researchers are excited about EYE103 because it potentially enhances treatment effectiveness for patients who are either new to treatment or those who haven't fully responded to existing therapies. This flexibility and potential for improved outcomes make EYE103 a promising development in eye care.
What evidence suggests that this trial's treatments could be effective for macular degeneration and macular edema?
Research has shown that EYE103 may help treat eye conditions such as neovascular age-related macular degeneration (NVAMD) and macular edema after branch retinal vein occlusion (BRVO). Participants in this trial will receive either high or low doses of EYE103. In earlier studies, patients receiving the highest dose of EYE103 required 81.2% fewer additional anti-VEGF injections, which are typically used for these conditions. For NVAMD, both high and low doses of EYE103 have shown promise in improving vision clarity and reducing fluid in the retina. For BRVO, similar treatments have led to better vision and reduced retinal thickness. Additionally, some participants in this trial will receive EYE103 combined with Aflibercept, a common eye injection. Early results suggest that this combination may lead to even better outcomes, particularly in reducing retinal fluid and improving vision.36789
Who Is on the Research Team?
Charles Miller, MD PhD
Principal Investigator
EyeBiotech Ltd.
Are You a Good Fit for This Trial?
This trial is for people with neovascular age-related macular degeneration (NVAMD) or swelling in the retina due to a blocked vein (macular edema following BRVO). Participants will be divided into four groups, and each group will receive either a low or high dose of EYE103. There are specific requirements for joining, but those details aren't provided here.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive 3 injections of EYE103 into the study eye, spaced 4 weeks apart, with safety and efficacy assessments at each visit
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- EYE103
Find a Clinic Near You
Who Is Running the Clinical Trial?
EyeBiotech Ltd.
Lead Sponsor