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Clinical Trials in the USA / NCT07449936
Active, not recruiting Phase 3

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

NCT07449936 · tracked via the Priya Life Science USA tracker
Sponsor
EyePoint Pharmaceuticals, Inc.
Phase
Phase 3
Started
2026-02-16
Last updated
2026-09-03

Condition(s) studied

Diabetic Macular EdemaDMEDiabetic Macular Edema (DME)

Investigational drug(s) / intervention(s)

EYP-1901Aflibercept (2.0 mg)

EYP-1901: Intravitreal Injection

Aflibercept (2.0 mg): Intravitreal Injection

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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 equivalent) in the fellow eye.

Primary outcome measure(s)

Trial sites (73)

FacilityCityRegionStatus
California Retina Consultants Bakersfield California
The Retina Partners Encino California
Global Research Management, Inc. Glendale California
Northern California Retina Vitreous Associates Medical Group INC. Mountain View California
Retina Consultants of San Diego Poway California
California Eye Specialists Medical Group, Inc. Redlands California
Retinal Consultants Medical Group - Parkcenter Drive Sacramento California
Retinal Consultants Medical Group Sacramento California
Retina Consultants of Southern Colorado Colorado Springs Colorado
Colorado Retina Associates Lakewood Colorado
Advanced Research LLC Sibia Eye Institute Boynton Beach Florida
Advance Medical Research Group, Inc Deerfield Beach Florida
Eye Associates of Pinellas Pinellas Park Florida
Retina Vitreous Associates of Florida - Saint Petersburg St. Petersburg Florida
Southern Vitreoretinal Associates Tallahassee Florida
Retina Specialists of Tampa Wesley Chapel Florida
Georgia Retina Marietta Georgia
Retina Consultants of Hawaii ‘Aiea Hawaii
Red River Research Partners Plainfield Illinois
Midwest Eye Institute - Carmel Carmel Indiana
Haik Humble Eye Center West Monroe Louisiana
Johns Hopkins Medicine - The Johns Hopkins Hospital Campus - Wilmer Eye Institute Baltimore Maryland
Retina Group of Washington Chevy Chase Maryland
Cumberland Valley Retina Consultants Hagerstown Maryland
Retina Specialists - Towson Towson Maryland
New England Retina Consultants Springfield Massachusetts
Retina Associates of Michigan Grand Blanc Michigan
Foundation for Vision Research Grand Rapids Michigan
Sierra Eye Associates Reno Nevada
NJRetina Care Center - Teaneck Teaneck New Jersey
NJ Retina - Toms River Toms River New Jersey
Retina Associates of Western New York Rochester New York
VRCNY/Long Island Vitreoretinal Consultants Westbury New York
Asheville Eye Associates - Regional Medical Park Asheville North Carolina
Cape Fear Retinal Associates, PC Wilmington North Carolina
Piedmont Retina Specialists, P.A. - Winston-Salem Office Winston-Salem North Carolina
Tulsa Retina Consultant Tulsa Oklahoma
Erie Retina Research Erie Pennsylvania
Charleston Neuroscience Institute - Beaufort Beaufort South Carolina
Retina Consultants of Carolina P.A Greenville South Carolina

+ 33 more sites — see the full list on the official registry below.

More EyePoint Pharmaceuticals, Inc. trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07449936 on ClinicalTrials.gov ↗ ← All trials in the USA