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

Conditions

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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• EYE103 — DRUG
  EYE103 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 EYE103.

Study Details

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 Dates

Start date

Sep 12, 2025

Status verified

Sep 2025

Primary completion

Jun 30, 2028

Completion

Jun 30, 2028

Study Design

Enrollment

160 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Treatment Naïve NVAMD - Low Dose EYE103
  Treatment Naïve NVAMD Cohort - Low Dose EYE103 (50 μL)
• Experimental: Treatment Naïve NVAMD - High Dose EYE103
  Treatment Naïve NVAMD Cohort - High Dose EYE103 (50 μL)
• Experimental: IR NVAMD - Low Dose EYE103
  Incomplete Responder (IR) NVAMD Cohort - Low Dose EYE103 (50 μL)
• Experimental: IR NVAMD - High Dose EYE103
  Incomplete Responder (IR) NVAMD Cohort - High Dose EYE103 (50 μL)
• Experimental: IR NVAMD - Low Dose EYE103 in combination with Aflibercept 2.0 mg
  Incomplete Responder (IR) NVAMD Cohort - Low Dose EYE103 (50 μL) in combination with Aflibercept 2.0 mg
• Experimental: IR NVAMD - High Dose EYE103 in combination with Aflibercept 2.0 mg
  Incomplete Responder (IR) NVAMD Cohort - High Dose EYE103 (50 μL) in combination with Aflibercept 2.0 mg
• Experimental: Treatment Naïve BRVO - Low Dose EYE103
  Treatment Naïve BRVO Cohort - Low Dose EYE103 (50 μL)
• Experimental: Treatment Naïve BRVO - High Dose EYE103
  Treatment Naïve BRVO Cohort - High Dose EYE103 (50 μL)

Primary Outcome Measure

Change from baseline in Best-Corrected Visual Acuity measured using the standardized Early Treatment of Diabetic Retinopathy Study (ETDRS) chart [ Time Frame: Week 12 ]

Central Contacts

• Charles Miller, MD PhD
  212-914-0127
  [email protected]

Locations (49)

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