COMO: A Phase 3 Randomized, Double-Masked Study Comparing the Efficacy of EYP-1901 Against
This is a phase 3 randomized, double -masked study comparing the efficacy of EYP-1901 against Aflibercept.
| Condition(s) | Diabetic Macular Edema, DME, Diabetic Macular Edema (DME) |
|---|---|
| Status | Recruiting |
| Phase | Phase 3 |
| Study type | Interventional |
| Summary | This is a phase 3 randomized, double -masked study comparing the efficacy of EYP-1901 against Aflibercept. |
| Who can participate | Inclusion Criteria: * Previously treated or treatment naïve patients with a documented diagnosis of macular edema associated with diabetic retinopathy (DR) in the study eye, with onset of disease that began at any time prior to the Screening Visit. * Best-corrected visual acuity (BCVA) Early Treatment Diabetic Retinopathy Study (ETDRS) letter score of 35 letters (20/200 Snellen equivalent) to 78 letters (20/32 Snellen equivalent) in the study eye at the Screening Visit and at Baseline (Day 1). * For previously treated participants: at least 1 injection of anti-VEGF in the past 12 months, the most recent anti-VEGF treatment for DME must not have been administered less than 12 weeks prior to the Screening Visit. Exclusion Criteria: * BCVA using ETDRS charts \<30 letters (20/250 Snellen equiv |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | EyePoint Pharmaceuticals, Inc. |
| Locations | Bakersfield, California, United States; Encino, California, United States; Glendale, California, United States; Mountain View, California, United States; Poway, California, United States; Redlands, California, United States (+59 more sites) |
| Start date | 2026-02-16 |
| NCT ID | NCT07449936 |
| Official listing | https://clinicaltrials.gov/study/NCT07449936 |