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NCT07449936PHASE3Recruiting

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

EyePoint Pharmaceuticals, Inc.

Start Date

2/16/2026

Completion Date

10/1/2028

Summary

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

Eligibility Criteria

Age Range: 18 years to No maximum

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.

Interventions

DRUG

EYP-1901

DRUG

Aflibercept (2.0 mg)

Interested in This Trial?

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Conditions

Diabetic Macular EdemaDMEDiabetic Macular Edema (DME)

Locations

California Retina Consultants

Bakersfield, California 93309

United States

The Retina Partners

Encino, California 91436

United States

Global Research Management, Inc.

Glendale, California 91204

United States

Northern California Retina Vitreous Associates Medical Group INC.

Mountain View, California 94040

United States

Retina Consultants of San Diego

Poway, California 92064

United States

California Eye Specialists Medical Group, Inc.

Redlands, California 92373

United States

Retinal Consultants Medical Group - Parkcenter Drive

Sacramento, California 95825

United States

Retinal Consultants Medical Group

Sacramento, California 95841

United States

Retina Consultants of Southern Colorado

Colorado Springs, Colorado 80909

United States

Colorado Retina Associates

Lakewood, Colorado 80228

United States

Advance Medical Research Group, Inc

Deerfield Beach, Florida 33064

United States

Eye Associates of Pinellas

Pinellas Park, Florida 33782

United States

Retina Vitreous Associates of Florida - Saint Petersburg

St. Petersburg, Florida 33711

United States

Southern Vitreoretinal Associates

Tallahassee, Florida 32308

United States

Retina Specialists of Tampa

Wesley Chapel, Florida 33544

United States

Georgia Retina

Marietta, Georgia 30060

United States

Retina Consultants of Hawaii

‘Aiea, Hawaii 96701

United States

Red River Research Partners

Plainfield, Illinois 60586

United States

Midwest Eye Institute - Carmel

Carmel, Indiana 11220

United States

Haik Humble Eye Center

West Monroe, Louisiana 71291

United States

Johns Hopkins Medicine - The Johns Hopkins Hospital Campus - Wilmer Eye Institute

Baltimore, Maryland 21287

United States

Retina Group of Washington

Chevy Chase, Maryland 20815

United States

Cumberland Valley Retina Consultants

Hagerstown, Maryland 21740

United States

Retina Specialists - Towson

Towson, Maryland 21204

United States

New England Retina Consultants

Springfield, Massachusetts 01107

United States

Retina Associates of Michigan

Grand Blanc, Michigan 48439

United States

Foundation for Vision Research

Grand Rapids, Michigan 49546

United States

Sierra Eye Associates

Reno, Nevada 89502

United States

NJRetina Care Center - Teaneck

Teaneck, New Jersey 07666

United States

NJ Retina - Toms River

Toms River, New Jersey 08755

United States

Retina Associates of Western New York

Rochester, New York 14620

United States

VRCNY/Long Island Vitreoretinal Consultants

Westbury, New York 11590

United States

Asheville Eye Associates - Regional Medical Park

Asheville, North Carolina 28803

United States

Cape Fear Retinal Associates, PC

Wilmington, North Carolina 28401

United States

Piedmont Retina Specialists, P.A. - Winston-Salem Office

Winston-Salem, North Carolina 27103

United States

Tulsa Retina Consultant

Tulsa, Oklahoma 74114

United States

Erie Retina Research

Erie, Pennsylvania 16507

United States

Charleston Neuroscience Institute - Beaufort

Beaufort, South Carolina 29902

United States

Retina Consultants of Carolina P.A

Greenville, South Carolina 29605

United States

Tennessee Retina

Nashville, Tennessee 37203

United States

Retina Research Institute of Texas Integrated Clinical Research

Abilene, Texas 79606

United States

Texas Retina Associates

Dallas, Texas 75231

United States

Mt. Olympus Medical Research

Houston, Texas 77479

United States

Retina Consultants of Texas

Katy, Texas 77494

United States

Texas Retina Associates

Plano, Texas 75075

United States

Retina Consultants of Texas

Schertz, Texas 78154

United States

Retina Associates of Utah

Salt Lake City, Utah 84107

United States

Salt Lake Retina

West Jordan, Utah 84088

United States

Piedmont Eye Center

Lynchburg, Virginia 24502

United States

Virginia Retina Center

Warrenton, Virginia 20186

United States

Northeast Wisconsin Retina Associates

Appleton, Wisconsin 54914

United States

Universitatsklinikum Carl Gustav Carus Dresden

Dresden,

Germany

Augenklinik Universitaetsmedizin der Johannes Gutenberg-Univ.

Mainz,

Germany

Shamir Medical Center Ophthalmology Out Patient Clinic

Be’er Ya‘aqov,

Israel

Bnai Zion Medical Center

Haifa,

Israel

Carmel Medical Center

Haifa,

Israel

Rambam Health Care Campus (RHCC)

Haifa,

Israel

Meir Medical Center Ophthalmology Department

Kfar Saba,

Israel

Rabin Medical Center

Petah Tikva,

Israel

Kaplan Medical Center

Rehovot,

Israel

The Tel-Aviv Sourasky Medical Centre

Tel Aviv,

Israel

Oculomedica Sp. z o.o.

Bydgoszcz,

Poland

OFTALMIKA Sp. z o.o

Bydgoszcz,

Poland

Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie

Lublin,

Poland

Centrum Diagnostyki i Mikrochirurgii Oka -LENS Sp. z o. o

Olsztyn,

Poland

Centrum Medyczne UNO-MED

Tarnów,

Poland

Warszawski Szpital Okulistyczny

Warsaw,

Poland

Fakultna nemocnica s poliklinikou F. D. Roosevelta Banska Bystrica

Banská Bystrica,

Slovakia

Oftalmocentrum Betliarska

Bratislava,

Slovakia

Nemocnica s poliklinikou Trebisov a.s.

Trebišov,

Slovakia