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

Recruiting now · Phase 2

Conditions studied: Neovascular Age-Related Macular Degeneration (NVAMD), Branch Retinal Vein Occlusion (BRVO)

In brief

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.

Key facts

Study ID

NCT07205887

Run by

EyeBiotech Ltd.

People needed

160

Starts

2025-09-12

Expected to finish

2028-06-30

Last updated by the study team

2026-06-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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
• 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

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
• Key BRVO-specific Exclusion Criteria
• Have macular edema in the study eye considered to be secondary to a cause other than BRVO (eg, diabetic macular edema, NVAMD, Irvine-Gass syndrome)
• Have active iris or angle neovascularization or neovascular glaucoma in the study eye

Where it is running

• Scottsdale, Arizona — Scottsdale, Arizona, United States (enrolling)
• Scottsdale, AZ — Scottsdale, Arizona, United States (enrolling)
• Glendale, California — Glendale, California, United States (enrolling)
• Glendale, CA — Glendale, California, United States (enrolling)
• Modesto, California — Modesto, California, United States (enrolling)
• Mountain View, California — Mountain View, California, United States (enrolling)
• Sacramento, CA — Sacramento, California, United States (enrolling)
• Sactamento, California — Sacramento, California, United States (enrolling)
• Sacramento, California — Sacramento, California, United States (enrolling)
• Santa Ana, California — Santa Ana, California, United States (enrolling)
• Fort Lauderdale, Florida — Fort Lauderdale, Florida, United States (enrolling)
• Fort Lauderdale, FL — Fort Lauderdale, Florida, United States (enrolling)
• Lemont, Illinois — Lemont, Illinois, United States (enrolling)
• Lemont, IL — Lemont, Illinois, United States (enrolling)
• Hagerstown, Maryland — Hagerstown, Maryland, United States (enrolling)
• Hagerstown, MD — Hagerstown, Maryland, United States (enrolling)
• Madison, Mississippi — Madison, Mississippi, United States (enrolling)
• Madison, MS — Madison, Mississippi, United States (enrolling)
• Bloomfield, New Jersey — Bloomfield, New Jersey, United States (enrolling)
• Bloomfield, NJ — Bloomfield, New Jersey, United States (enrolling)
• Asheville, North Carolina — Asheville, North Carolina, United States (enrolling)
• Cary, North Carolina — Cary, North Carolina, United States (enrolling)
• Wake Forest, NC — Wake Forest, North Carolina, United States (enrolling)
• Wake Forest, North Carolina — Wake Forest, North Carolina, United States (enrolling)
• West Columbia, SC — West Columbia, South Carolina, United States (enrolling)

Full record on ClinicalTrials.gov

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