RecruitingNeovascular Age-Related Macular Degeneration (NVAMD)Branch Retinal Vein Occlusion (BRVO)

A Dose-masked Study of Intravitreal EYE103 in Participants With NVAMD or Macular Edema Following BRVO

Eligible age

18+ yrs

Accepts

All genders

Locations

12 states

Healthy volunteers

See if you qualify for this study

Answer a few quick questions about your location and health. Takes about a minute.

Check my eligibility →

About this study

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.

Sponsor: EyeBiotech Ltd.

You may qualify if…

✓ 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

You may not qualify if…

✕ Key General Exclusion Criteria
✕ Pregnant or breastfeeding
✕ History of cataract surgery and/or minimally invasive glaucoma surgery in the study eye within 90 days of Screening
✕ Have had Yttrium-Aluminum Garnet (YAG) laser capsulotomy in the study eye within 90 days of Screening
✕ Currently using drugs with known retinal toxicity (e.g., Hydroxychloroquine, pentosan polysulfate sodium, and amiodarone)
✕ Key NVAMD-specific Exclusion Criteria
✕ Have had previous thermal subfoveal laser therapy in the study eye
✕ Have had previous photodynamic therapy with Visudyne in the study eye