drugset / Trial / NCT07205887

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

NCT07205887

Phase 2 Recruiting 160 enrolled EyeBiotech Ltd.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

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.

Timeline

Start
2025-09-12
Primary completion
2028-06-30
Completion
2028-06-30

Drugs

EvaluationDrugModalityDoseRoute
Subject EYE103 Unknown 0.05 ml Intravitreal
Background Aflibercept Protein / enzyme biologic 2 mg Intravitreal