EYE103 eye injections for wet AMD or BRVO-related macular edema
A Phase 2 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)
PHASE2 · EyeBiotech Ltd. · NCT07205887
This trial will test whether two different doses of intravitreal EYE103 help adults with neovascular (wet) age-related macular degeneration or macular edema after BRVO.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 160 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | EyeBiotech Ltd. (industry) |
| Locations | 49 sites (Scottsdale, Arizona and 48 other locations) |
| Trial ID | NCT07205887 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults (generally ≥50 for the AMD cohorts) with active neovascular AMD—either treatment‑naïve or incomplete responders depending on cohort—or adults with BRVO‑related macular edema who can attend clinic visits at the study sites.
Not a fit: Patients who do not meet the age, anatomical, or prior‑treatment criteria, or who have other ocular or systemic conditions that preclude intravitreal injections, are unlikely to benefit from this trial.
Why it matters
Potential benefit: If successful, EYE103 could provide an additional intravitreal treatment option to reduce macular swelling and improve vision with a short three‑injection course.
How similar studies have performed: Other intravitreal anti‑VEGF agents and some combination approaches have shown benefit for NVAMD and BRVO, but EYE103 itself is a novel agent without large‑scale clinical proof to date.
Eligibility criteria
Show full inclusion / exclusion criteria
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 * Be male or female ≥18 years of age. Key NVAMD-specific Inclusion Criteria * Be ≥ 50 years of age * Have treatment naive subfoveal CNV secondary to 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 IR NVAMD-specific Inclusion Criteria * Be ≥ 50 years of age * Have treatment naive subfoveal CNV secondary to AMD or juxtafoveal/extrafoveal CNV with foveal involvement at initial screening * For participants who are treatment naïve for NVAMD, the diagnosis must have been made within 21 days prior to the Screening Visit 2 Key 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 * Be 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 * Are 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, DME, NVAMD, Irvine-Gass syndrome) * Have active iris or angle neovascularization or neovascular glaucoma in the study eye
Where this trial is running
Scottsdale, Arizona and 48 other locations
- 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)
- Sacramento, CA — Sacramento, California, United States (RECRUITING)
- Sactamento, California — Sacramento, California, United States (RECRUITING)
- Sacramento, California — Sacramento, California, United States (RECRUITING)
- Santa Ana, California — Santa Ana, California, United States (RECRUITING)
- Fort Lauderdale, Florida — Fort Lauderdale, Florida, United States (RECRUITING)
- Fort Lauderdale, FL — Fort Lauderdale, Florida, United States (RECRUITING)
- Lemont, Illinois — Lemont, Illinois, United States (RECRUITING)
- Lemont, IL — Lemont, Illinois, United States (RECRUITING)
- Hagerstown, Maryland — Hagerstown, Maryland, United States (RECRUITING)
- Hagerstown, MD — Hagerstown, Maryland, United States (RECRUITING)
- Madison, Mississippi — Madison, Mississippi, United States (RECRUITING)
- Madison, MS — Madison, Mississippi, United States (RECRUITING)
- Bloomfield, New Jersey — Bloomfield, New Jersey, United States (RECRUITING)
- Bloomfield, NJ — Bloomfield, New Jersey, United States (RECRUITING)
- Asheville, North Carolina — Asheville, North Carolina, United States (RECRUITING)
- Cary, North Carolina — Cary, North Carolina, United States (RECRUITING)
- Wake Forest, NC — Wake Forest, North Carolina, United States (RECRUITING)
- Wake Forest, North Carolina — Wake Forest, North Carolina, United States (RECRUITING)
- West Columbia, SC — West Columbia, South Carolina, United States (RECRUITING)
- West Columbia, South Carolina — West Columbia, South Carolina, United States (RECRUITING)
- Germantown, Tennessee — Germantown, Tennessee, United States (RECRUITING)
- Knoxville, Tennessee — Knoxville, Tennessee, United States (RECRUITING)
- Nashville, Tennessee — Nashville, Tennessee, United States (RECRUITING)
- Nashville, TN — Nashville, Tennessee, United States (RECRUITING)
- Abilene, Texas — Abilene, Texas, United States (RECRUITING)
- Amarillo, Texas — Amarillo, Texas, United States (RECRUITING)
- Austin, Texas — Austin, Texas, United States (RECRUITING)
- Austin, TX — Austin, Texas, United States (RECRUITING)
- Bellaire, Texas — Bellaire, Texas, United States (RECRUITING)
- Bellaire, TX — Bellaire, Texas, United States (RECRUITING)
- Burleson, Texas — Burleson, Texas, United States (RECRUITING)
- Dallas, Texas — Dallas, Texas, United States (RECRUITING)
- Dallas, TX — Dallas, Texas, United States (RECRUITING)
- Plano, Texas — Plano, Texas, United States (RECRUITING)
- Round Rock, TX — Round Rock, Texas, United States (RECRUITING)
- Round Rock, Texas — Round Rock, Texas, United States (RECRUITING)
- San Antonio, Texas — San Antonio, Texas, United States (RECRUITING)
- San Antonio, TX — San Antonio, Texas, United States (RECRUITING)
- San Marcos, Texas — San Marcos, Texas, United States (RECRUITING)
- The Woodlands, Texas — The Woodlands, Texas, United States (RECRUITING)
- The Woodlands, TX — The Woodlands, Texas, United States (RECRUITING)
- Willow Park, Texas — Willow Park, Texas, United States (RECRUITING)
- West Jordan, Utah — West Jordan, Utah, United States (RECRUITING)
Study contacts
- Study coordinator: Charles Miller, MD PhD
- Email: ClinicalInquiries@eyebiotech.com
- Phone: 212-914-0127
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Neovascular Age-Related Macular Degeneration, Branch Retinal Vein Occlusion, NVAMD, BRVO