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RECRUITING Phase 2 ClinicalTrials.gov

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

Sponsor: EyeBiotech Ltd. • ClinicalTrials.gov ID: NCT07205887

Registry updated: 2026-10-20
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Description

EYE-RES-104 is a randomized, dose-masked study of intravitreal remigromig (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 remigromig via IVT or a high dose of remigromig 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 remigromig 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.

Interventions

  • Remigromig (Drug)
    Remigromig is a humanized antibody formulated for intravitreal administration
  • Aflibercept 2.0 mg (Drug)
    Aflibercept 2.0 mg is a commercially available anti-VEGF treatment formulated for intravitreal administration for use in patients with Neovascular Age-Related Macular Degeneration (NVAMD). Aflibercept 2.0 mg is only administered to 2 cohorts of Incomplete Responders (IR) with NVAMD in combination with Low Dose or High Dose Remigromig.

Eligibility 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 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

Conditions

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

Locations

  • Scottsdale, Arizona — Scottsdale, Arizona, United States
  • Scottsdale, AZ — Scottsdale, Arizona, United States
  • Glendale, California — Glendale, California, United States
  • Glendale, CA — Glendale, California, United States
  • Modesto, California — Modesto, California, United States
  • Mountain View, California — Mountain View, California, United States
  • Sacramento, CA — Sacramento, California, United States
  • Sactamento, California — Sacramento, California, United States
  • Sacramento, California — Sacramento, California, United States
  • Santa Ana, California — Santa Ana, California, United States
  • RSC Research LLC — Denver, Colorado, United States
  • Fort Lauderdale, Florida — Fort Lauderdale, Florida, United States
  • Fort Lauderdale, FL — Fort Lauderdale, Florida, United States
  • Florida Retina Institute — Jacksonville, Florida, United States
  • Florida Retina Institute — Orlando, Florida, United States
  • Lemont, Illinois — Lemont, Illinois, United States
  • Lemont, IL — Lemont, Illinois, United States
  • Hagerstown, Maryland — Hagerstown, Maryland, United States
  • Hagerstown, MD — Hagerstown, Maryland, United States
  • Madison, Mississippi — Madison, Mississippi, United States
  • Madison, MS — Madison, Mississippi, United States
  • Bloomfield, New Jersey — Bloomfield, New Jersey, United States
  • Bloomfield, NJ — Bloomfield, New Jersey, United States
  • Long Island Vitreoretinal Consultants of NY — Great Neck, New York, United States
  • Asheville, North Carolina — Asheville, North Carolina, United States
  • Cary, North Carolina — Cary, North Carolina, United States
  • North Carolina Retina Associates — Greenville, North Carolina, United States
  • Wake Forest, NC — Wake Forest, North Carolina, United States
  • Wake Forest, North Carolina — Wake Forest, North Carolina, United States
  • West Columbia, SC — West Columbia, South Carolina, United States
  • West Columbia, South Carolina — West Columbia, South Carolina, United States
  • Germantown, Tennessee — Germantown, Tennessee, United States
  • Knoxville, Tennessee — Knoxville, Tennessee, United States
  • Nashville, Tennessee — Nashville, Tennessee, United States
  • Nashville, TN — Nashville, Tennessee, United States
  • Abilene, Texas — Abilene, Texas, United States
  • Amarillo, Texas — Amarillo, Texas, United States
  • Austin, Texas — Austin, Texas, United States
  • Austin, TX — Austin, Texas, United States
  • Bellaire, Texas — Bellaire, Texas, United States
  • Bellaire, TX — Bellaire, Texas, United States
  • Burleson, Texas — Burleson, Texas, United States
  • Dallas, Texas — Dallas, Texas, United States
  • Dallas, TX — Dallas, Texas, United States
  • Plano, Texas — Plano, Texas, United States
  • Round Rock, TX — Round Rock, Texas, United States
  • Round Rock, Texas — Round Rock, Texas, United States
  • San Antonio, Texas — San Antonio, Texas, United States
  • San Antonio, TX — San Antonio, Texas, United States
  • San Marcos, Texas — San Marcos, Texas, United States
  • The Woodlands, Texas — The Woodlands, Texas, United States
  • The Woodlands, TX — The Woodlands, Texas, United States
  • Willow Park, Texas — Willow Park, Texas, United States
  • West Jordan, Utah — West Jordan, Utah, United States
  • Retina Consultants, PLLC — Charleston, West Virginia, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record