A Dose-masked Study of Intravitreal EYE103 in Participants With NVAMD or Macular Edema Following … (NCT07205887) | Clinical Trial Compass
RecruitingPhase 2
A Dose-masked Study of Intravitreal EYE103 in Participants With NVAMD or Macular Edema Following BRVO
United States160 participantsStarted 2025-09-12
Plain-language summary
EYE-RES-104 is a randomized, dose-masked study of intravitreal EYE103 in participants with neovascular age-related macular degeneration (NVAMD) or macular edema following branch retinal vein occlusion (BRVO).
The study will consist of 4 patient cohorts, with participants in each cohort randomized (1:1) to either a low dose of EYE103 via IVT or a high dose of EYE103 via IVT. 40 participants will be enrolled in each cohort. Enrollment timing for each cohort will be sequenced into specific arms of the study at the Sponsor's discretion.
All participants in the study will receive a total of 3 injections of EYE103 into the study eye, spaced at 4 weeks apart. All participants will return at designated time points following each injection for safety and efficacy assessments. The Week 12 Visit will serve as the end of study visit for all participants.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Key General Inclusion Criteria
• Be willing and able to understand the study procedures and the risks involved and provide written informed consent before the first study-related activity
Key Neovascular Age-related Macular Degeneration (NVAMD)-specific Inclusion Criteria
* Be ≥ 50 years of age
* Have treatment naive subfoveal choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD) or juxtafoveal/extrafoveal CNV with foveal involvement
* For participants who are treatment naïve for NVAMD, the diagnosis must have been made within 21 days prior to the Day 1 study treatment
Key Incomplete Responder (IR) NVAMD-specific Inclusion Criteria
* Be ≥ 50 years of age
* Have subfoveal CNV secondary to AMD or juxtafoveal/extrafoveal CNV with foveal involvement at initial screening
* For participants who are treatment experienced for NVAMD, the diagnosis must have been made within 90 days prior to the Screening Visit 2
Key Branch Retinal Vein Occlusion (BRVO)-specific Inclusion Criteria
* Be diagnosed with BRVO in the study eye
* Have a decrease in vision in the study eye determined by the Investigator to be primarily the result of BRVO
* Be treatment naïve with vision loss in the study eye and have center-involving macular edema diagnosed within 9 months of Screening
Exclusion Criteria:
Key General Exclusion Criteria
* Pregnant or breastfeeding
* History of cataract surgery and/or minimally invasive glaucoma surgery in the stud…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This is a Phase 2 trial for EYE103, which means it's still in relatively early testing — what do we know so far about how safe this drug is, and what gaps in the safety data should I be aware of before considering it?
2The trial is measuring changes in best-corrected visual acuity using the ETDRS chart — does that mean my current vision level would be a key factor in whether I'm even a candidate, and how does my baseline vision compare to what they're likely looking for?
3EYE103 is given as an intravitreal injection, similar to existing treatments for wet AMD or BRVO — how does this experimental drug differ from anti-VEGF injections I might already be receiving or could receive as standard care?
4Since this is described as 'dose-masked,' meaning neither I nor the study team knows which dose I'm getting, how might that affect my monitoring or my ability to switch to a different treatment if my condition changes?
5Given that standard-of-care treatments already exist for both wet AMD and BRVO, would you recommend I try or continue those first, or is there a specific reason this trial might be worth considering alongside or instead of those options for my situation?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change from baseline in Best-Corrected Visual Acuity measured using the standardized Early Treatment of Diabetic Retinopathy Study (ETDRS) chart