EYE103 eye injections for wet AMD or BRVO-related macular edema

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

EYE-RES-104 randomizes adults with neovascular AMD or BRVO-related macular edema into four cohorts (treatment‑naïve NVAMD, two incomplete‑responder NVAMD cohorts—one monotherapy and one combined with aflibercept—and treatment‑naïve BRVO), each with 40 participants randomized 1:1 to a low or high dose of intravitreal EYE103. Participants receive three EYE103 injections spaced four weeks apart, and the combination cohort also receives a single aflibercept 2.0 mg injection on Day 1; dosing is dose‑masked. Safety and efficacy are monitored at injection visits and scheduled follow‑ups through a Week 12 end‑of‑study visit, with sponsor‑sequenced enrollment of cohorts. The trial will collect visual and anatomical outcomes and adverse event data to compare the two dose levels.

Why it matters

Who can join: the full rules

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 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's running

• Scottsdale, Arizona
  Scottsdale, Arizona, United States Recruiting
• Scottsdale, AZ
  Scottsdale, Arizona, United States Recruiting
• Glendale, California
  Glendale, California, United States Recruiting
• Glendale, CA
  Glendale, California, United States Recruiting
• Modesto, California
  Modesto, California, United States Recruiting
• Mountain View, California
  Mountain View, California, United States Recruiting

+5 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Charles Miller, MD PhD
• Email: ClinicalInquiries@eyebiotech.com
• Phone: 212-914-0127

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.