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

NCT07449936 | Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: EYP-1901-303
• Study Type: interventional
• Target: 240
• Locations: 5 countries
• Sites: 70

Brief Summary

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

Conditions

Diabetic Macular Edema; DME; Diabetic Macular Edema (DME)

Keywords

EyePoint; EYP-1901; Tyrosine Kinase Inhibitor; Diabetic Macular Edema

Outcome Measures

Primary Outcomes (1)

• Average change in best corrected visual acuity (BCVA)

  BCVA Early Treatment Diabetic Retinopathy Study (ETDRS) letter score change from Baseline to the average of Weeks 52 and 56

  Weeks 52 and 56

Secondary Outcomes (1)

• Rate of injection burden

  Week 56

Study Arms (2)

EYP-1901 2686 µg

EXPERIMENTAL

EYP-1901

Drug: EYP-1901

Aflibercept

ACTIVE COMPARATOR

Drug: Aflibercept (2.0 mg)

Interventions

EYP-1901 DRUG

Intravitreal Injection

EYP-1901 2686 µg

Aflibercept (2.0 mg) DRUG

Intravitreal Injection

Aflibercept

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• EyePoint Pharmaceuticals, Inc.: lead

Study Sites (70)

California Retina Consultants

Bakersfield, California, 93309, United States

RECRUITING

The Retina Partners

Encino, California, 91436, United States

RECRUITING

Global Research Management, Inc.

Glendale, California, 91204, United States

RECRUITING

Northern California Retina Vitreous Associates Medical Group INC.

Mountain View, California, 94040, United States

RECRUITING

Retina Consultants of San Diego

Poway, California, 92064, United States

RECRUITING

California Eye Specialists Medical Group, Inc.

Redlands, California, 92373, United States

RECRUITING

Retinal Consultants Medical Group - Parkcenter Drive

Sacramento, California, 95825, United States

RECRUITING

Retinal Consultants Medical Group

Sacramento, California, 95841, United States

RECRUITING

Retina Consultants of Southern Colorado

Colorado Springs, Colorado, 80909, United States

RECRUITING

Colorado Retina Associates

Lakewood, Colorado, 80228, United States

RECRUITING

Advance Medical Research Group, Inc

Deerfield Beach, Florida, 33064, United States

RECRUITING

Eye Associates of Pinellas

Pinellas Park, Florida, 33782, United States

RECRUITING

Retina Vitreous Associates of Florida - Saint Petersburg

St. Petersburg, Florida, 33711, United States

RECRUITING

Southern Vitreoretinal Associates

Tallahassee, Florida, 32308, United States

RECRUITING

Retina Specialists of Tampa

Wesley Chapel, Florida, 33544, United States

RECRUITING

Georgia Retina

Marietta, Georgia, 30060, United States

RECRUITING

Retina Consultants of Hawaii

‘Aiea, Hawaii, 96701, United States

RECRUITING

Red River Research Partners

Plainfield, Illinois, 60586, United States

RECRUITING

Midwest Eye Institute - Carmel

Carmel, Indiana, 11220, United States

RECRUITING

Haik Humble Eye Center

West Monroe, Louisiana, 71291, United States

RECRUITING

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

Baltimore, Maryland, 21287, United States

RECRUITING

Retina Group of Washington

Chevy Chase, Maryland, 20815, United States

RECRUITING

Cumberland Valley Retina Consultants

Hagerstown, Maryland, 21740, United States

COMPLETED

Retina Specialists - Towson

Towson, Maryland, 21204, United States

RECRUITING

New England Retina Consultants

Springfield, Massachusetts, 01107, United States

RECRUITING

Retina Associates of Michigan

Grand Blanc, Michigan, 48439, United States

RECRUITING

Foundation for Vision Research

Grand Rapids, Michigan, 49546, United States

RECRUITING

Sierra Eye Associates

Reno, Nevada, 89502, United States

RECRUITING

NJRetina Care Center - Teaneck

Teaneck, New Jersey, 07666, United States

RECRUITING

NJ Retina - Toms River

Toms River, New Jersey, 08755, United States

RECRUITING

Retina Associates of Western New York

Rochester, New York, 14620, United States

RECRUITING

VRCNY/Long Island Vitreoretinal Consultants

Westbury, New York, 11590, United States

RECRUITING

Asheville Eye Associates - Regional Medical Park

Asheville, North Carolina, 28803, United States

RECRUITING

Cape Fear Retinal Associates, PC

Wilmington, North Carolina, 28401, United States

RECRUITING

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

Winston-Salem, North Carolina, 27103, United States

RECRUITING

Tulsa Retina Consultant

Tulsa, Oklahoma, 74114, United States

RECRUITING

Erie Retina Research

Erie, Pennsylvania, 16507, United States

RECRUITING

Charleston Neuroscience Institute - Beaufort

Beaufort, South Carolina, 29902, United States

RECRUITING

Retina Consultants of Carolina P.A

Greenville, South Carolina, 29605, United States

RECRUITING

Tennessee Retina

Nashville, Tennessee, 37203, United States

RECRUITING

Retina Research Institute of Texas Integrated Clinical Research

Abilene, Texas, 79606, United States

RECRUITING

Texas Retina Associates

Dallas, Texas, 75231, United States

RECRUITING

Mt. Olympus Medical Research

Houston, Texas, 77479, United States

RECRUITING

Retina Consultants of Texas

Katy, Texas, 77494, United States

RECRUITING

Texas Retina Associates

Plano, Texas, 75075, United States

RECRUITING

Retina Consultants of Texas

Schertz, Texas, 78154, United States

RECRUITING

Retina Associates of Utah

Salt Lake City, Utah, 84107, United States

RECRUITING

Salt Lake Retina

West Jordan, Utah, 84088, United States

RECRUITING

Piedmont Eye Center

Lynchburg, Virginia, 24502, United States

RECRUITING

Virginia Retina Center

Warrenton, Virginia, 20186, United States

RECRUITING

Northeast Wisconsin Retina Associates

Appleton, Wisconsin, 54914, United States

RECRUITING

Universitatsklinikum Carl Gustav Carus Dresden

Dresden, Germany

RECRUITING

Augenklinik Universitaetsmedizin der Johannes Gutenberg-Univ.

Mainz, Germany

RECRUITING

Shamir Medical Center Ophthalmology Out Patient Clinic

Be’er Ya‘aqov, Israel

RECRUITING

Bnai Zion Medical Center

Haifa, Israel

RECRUITING

Carmel Medical Center

Haifa, Israel

RECRUITING

Rambam Health Care Campus (RHCC)

Haifa, Israel

RECRUITING

Meir Medical Center Ophthalmology Department

Kfar Saba, Israel

RECRUITING

Rabin Medical Center

Petah Tikva, Israel

RECRUITING

Kaplan Medical Center

Rehovot, Israel

RECRUITING

The Tel-Aviv Sourasky Medical Centre

Tel Aviv, Israel

RECRUITING

Oculomedica Sp. z o.o.

Bydgoszcz, Poland

RECRUITING

OFTALMIKA Sp. z o.o

Bydgoszcz, Poland

RECRUITING

Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie

Lublin, Poland

RECRUITING

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

Olsztyn, Poland

RECRUITING

Centrum Medyczne UNO-MED

Tarnów, Poland

RECRUITING

Warszawski Szpital Okulistyczny

Warsaw, Poland

RECRUITING

Fakultna nemocnica s poliklinikou F. D. Roosevelta Banska Bystrica

Banská Bystrica, Slovakia

RECRUITING

Oftalmocentrum Betliarska

Bratislava, Slovakia

RECRUITING

Nemocnica s poliklinikou Trebisov a.s.

Trebišov, Slovakia

RECRUITING

MeSH Terms

Interventions

aflibercept

Central Study Contacts

Ramiro Ribeiro, MD, PhD

CONTACT

833-393-7646; rribeiro@eyepoint.bio

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2026
• First Posted: March 4, 2026
• Study Start: February 16, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2028
• Last Updated: July 6, 2026

Record last verified: 2026-07

Locations

IL (8); US (51); PL (6); DE (2); SL (3)