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Phase 3 Trial Comparing Eye Injections EYP-1901 and Aflibercept for Diabetic Macular Edema Treatment
Led by EyePoint Pharmaceuticals, Inc. · Updated on 2026-08-04
240
Participants Needed
73
Research Sites
52 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are conducting a phase 3 randomized, double-masked clinical trial to compare the effects of two treatments, EYP-1901 and Aflibercept, for patients with diabetic macular edema DME. This study aims to evaluate which treatment better improves visual acuity in people affected by this condition. EyePoint Pharmaceuticals, Inc. is leading this study to assess these injectable drugs impact on vision. Participants will receive either EYP-1901 or Aflibercept through intravitreal injections directly into the eye. The study uses a parallel assignment design with participants randomized to one of the two treatment groups. The trial is double-masked to ensure unbiased results, and the primary treatment period focuses on 52 to 56 weeks of follow-up after injections. During the study, participants will have their best-corrected visual acuity measured to assess changes in vision. Researchers will also monitor the frequency of injections required over the 56-week period to evaluate treatment burden. Participants will attend regular study visits for these assessments and safety monitoring throughout the trial duration, which ends in October 2028.
CONDITIONS
Brief Title
COMO: 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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