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

Recruiting now · Phase 3

Conditions studied: Diabetic Macular Edema, DME, Diabetic Macular Edema (DME)

In brief

This is a phase 3 randomized, double -masked study comparing the efficacy of EYP-1901 against Aflibercept.

Key facts

Study ID

NCT07449936

Run by

EyePoint Pharmaceuticals, Inc.

People needed

240

Starts

2026-02-16

Expected to finish

2028-10-01

Last updated by the study team

2026-08-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• BCVA using ETDRS charts <30 letters (20/250 Snellen equivalent) in the fellow eye.

Where it is running

• The Retina Partners — Encino, California, United States (enrolling)
• California Retina Consultants — Bakersfield, California, United States (enrolling)
• Northern California Retina Vitreous Associates Medical Group INC. — Mountain View, California, United States (enrolling)
• Retina Consultants of San Diego — Poway, California, United States (enrolling)
• Global Research Management, Inc. — Glendale, California, United States (enrolling)
• Retinal Consultants Medical Group - Parkcenter Drive — Sacramento, California, United States (enrolling)
• Retinal Consultants Medical Group — Sacramento, California, United States (enrolling)
• Retina Consultants of Southern Colorado — Colorado Springs, Colorado, United States (enrolling)
• Colorado Retina Associates — Lakewood, Colorado, United States (enrolling)
• Advanced Research LLC Sibia Eye Institute — Boynton Beach, Florida, United States (enrolling)
• California Eye Specialists Medical Group, Inc. — Redlands, California, United States (enrolling)
• Eye Associates of Pinellas — Pinellas Park, Florida, United States (enrolling)
• Retina Vitreous Associates of Florida - Saint Petersburg — St. Petersburg, Florida, United States (enrolling)
• Southern Vitreoretinal Associates — Tallahassee, Florida, United States (enrolling)
• Retina Specialists of Tampa — Wesley Chapel, Florida, United States (enrolling)
• Georgia Retina — Marietta, Georgia, United States (enrolling)
• Retina Consultants of Hawaii — ‘Aiea, Hawaii, United States (enrolling)
• Red River Research Partners — Plainfield, Illinois, United States (enrolling)
• Midwest Eye Institute - Carmel — Carmel, Indiana, United States (enrolling)
• Haik Humble Eye Center — West Monroe, Louisiana, United States (enrolling)
• Johns Hopkins Medicine - The Johns Hopkins Hospital Campus - Wilmer Eye Institute — Baltimore, Maryland, United States (enrolling)
• Retina Group of Washington — Chevy Chase, Maryland, United States (enrolling)
• Advance Medical Research Group, Inc — Deerfield Beach, Florida, United States (enrolling)
• Retina Specialists - Towson — Towson, Maryland, United States (enrolling)
• New England Retina Consultants — Springfield, Massachusetts, United States (enrolling)

Full record on ClinicalTrials.gov

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