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Actively Recruiting

Phase 3
Age: 18Years +
All Genders
ID07449923

Phase 3 Study Comparing Eye Injection EYP-1901 to Aflibercept for Diabetic Macular Edema Treatment

Led by EyePoint Pharmaceuticals, Inc. · Updated on 2026-08-04

240

Participants Needed

70

Research Sites

52 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are conducting a phase 3 randomized, double-masked study to compare the effects of EYP-1901 against Aflibercept in patients with diabetic macular edema DME, a condition related to diabetic retinopathy. The study aims to evaluate the treatments impact on vision improvement, with a focus on the average change in best-corrected visual acuity BCVA over one year. Participants are assigned to receive either EYP-1901 or Aflibercept, both delivered by intravitreal injection directly into the eye. The study uses a parallel group design with random allocation and masking to compare these two drug treatments. The primary measurement is taken at weeks 52 and 56, with secondary outcomes including the rate of injection burden by week 56. During the study, participants will undergo regular vision assessments using the ETDRS letter score. Researchers will monitor treatment effects and safety throughout the trial period, which extends until October 2028. The total participation time includes screening, treatment, and follow-up visits designed to evaluate vision changes and treatment needs over approximately one year.

CONDITIONS

Brief Title

CAPRI: A Phase 3 Randomized, Double-Masked Study Comparing the Efficacy of EYP-1901 Against Aflibercept in DME

Research Team

R

Ramiro Ribeiro, MD, PhD

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