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

June 1, 2026 updated by: EyePoint Pharmaceuticals, Inc.

A Phase 3, Multicenter, Prospective, Randomized, Double-Masked, Parallel-Group Study of EYP-1901, a Tyrosine Kinase Inhibitor (TKI), Compared to Aflibercept (2 mg) in Participants With Diabetic Macular Edema (DME)

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

240

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Germany
      • Mainz, Germany
        • Recruiting
        • Augenklinik Universitaetsmedizin der Johannes Gutenberg-Univ.
        • Contact:
  • Israel
      • Be’er Ya‘aqov, Israel
        • Recruiting
        • Shamir Medical Center Ophthalmology Out Patient Clinic
        • Contact:
      • Haifa, Israel
        • Recruiting
        • Bnai Zion Medical Center
        • Contact:
      • Haifa, Israel
        • Recruiting
        • Carmel Medical Center
        • Contact:
      • Haifa, Israel
        • Recruiting
        • Rambam Health Care Campus (RHCC)
        • Contact:
      • Kfar Saba, Israel
        • Recruiting
        • Meir Medical Center Ophthalmology Department
        • Contact:
      • Petah Tikva, Israel
        • Recruiting
        • Rabin Medical Center
        • Contact:
      • Rehovot, Israel
        • Recruiting
        • Kaplan Medical Center
        • Contact:
      • Tel Aviv, Israel
        • Recruiting
        • The Tel-Aviv Sourasky Medical Centre
        • Contact:
  • Poland
      • Bydgoszcz, Poland
        • Recruiting
        • OFTALMIKA Sp. z o.o
        • Contact:
      • Lublin, Poland
        • Recruiting
        • Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie
        • Contact:
      • Olsztyn, Poland
        • Recruiting
        • Centrum Diagnostyki i Mikrochirurgii Oka -LENS Sp. z o. o
        • Contact:
      • Tarnów, Poland
        • Recruiting
        • Centrum Medyczne UNO-MED
        • Contact:
      • Warsaw, Poland
        • Recruiting
        • Warszawski Szpital Okulistyczny
        • Contact:
  • Slovakia
      • Trebišov, Slovakia
        • Recruiting
        • Nemocnica s poliklinikou Trebisov a.s.
        • Contact:
  • United States
    • California
      • Bakersfield, California, United States, 93309
        • Recruiting
        • California Retina Consultants
        • Contact:
      • Encino, California, United States, 91436
        • Recruiting
        • The Retina Partners
        • Contact:
      • Glendale, California, United States, 91204
        • Recruiting
        • Global Research Management, Inc.
        • Contact:
      • Mountain View, California, United States, 94040
        • Recruiting
        • Northern California Retina Vitreous Associates Medical Group INC.
        • Contact:
      • Poway, California, United States, 92064
        • Recruiting
        • Retina Consultants of San Diego
        • Contact:
      • Redlands, California, United States, 92373
        • Recruiting
        • California Eye Specialists Medical Group, Inc.
        • Contact:
      • Sacramento, California, United States, 95841
        • Recruiting
        • Retinal Consultants Medical Group
        • Contact:
      • Sacramento, California, United States, 95825
        • Recruiting
        • Retinal Consultants Medical Group - Parkcenter Drive
        • Contact:
    • Colorado
      • Colorado Springs, Colorado, United States, 80909
        • Recruiting
        • Retina Consultants of Southern Colorado
        • Contact:
      • Lakewood, Colorado, United States, 80228
        • Recruiting
        • Colorado Retina Associates
        • Contact:
    • Florida
      • Deerfield Beach, Florida, United States, 33064
        • Recruiting
        • Advance Medical Research Group, Inc
        • Contact:
      • Pinellas Park, Florida, United States, 33782
        • Recruiting
        • Eye Associates of Pinellas
        • Contact:
      • St. Petersburg, Florida, United States, 33711
        • Recruiting
        • Retina Vitreous Associates of Florida - Saint Petersburg
        • Contact:
      • Tallahassee, Florida, United States, 32308
        • Recruiting
        • Southern Vitreoretinal Associates
        • Contact:
      • Wesley Chapel, Florida, United States, 33544
        • Recruiting
        • Retina Specialists of Tampa
        • Contact:
    • Georgia
      • Marietta, Georgia, United States, 30060
        • Recruiting
        • Georgia Retina
        • Contact:
    • Hawaii
      • ‘Aiea, Hawaii, United States, 96701
        • Recruiting
        • Retina Consultants Of Hawaii
        • Contact:
    • Illinois
      • Plainfield, Illinois, United States, 60586
        • Recruiting
        • Red River Research Partners
        • Contact:
    • Indiana
      • Carmel, Indiana, United States, 11220
        • Recruiting
        • Midwest Eye Institute - Carmel
        • Contact:
    • Louisiana
      • West Monroe, Louisiana, United States, 71291
        • Recruiting
        • Haik Humble Eye Center
        • Contact:
    • Maryland
      • Chevy Chase, Maryland, United States, 20815
        • Recruiting
        • Retina Group of Washington
        • Contact:
      • Hagerstown, Maryland, United States, 21740
        • Completed
        • Cumberland Valley Retina Consultants
      • Towson, Maryland, United States, 21204
        • Recruiting
        • Retina Specialists - Towson
    • Massachusetts
      • Springfield, Massachusetts, United States, 01107
        • Recruiting
        • New England Retina Consultants
        • Contact:
    • Michigan
      • Grand Blanc, Michigan, United States, 48439
        • Recruiting
        • Retina Associates of Michigan
        • Contact:
      • Grand Rapids, Michigan, United States, 49546
        • Recruiting
        • Foundation for Vision Research
        • Contact:
    • Nevada
      • Reno, Nevada, United States, 89502
        • Recruiting
        • Sierra Eye Associates
        • Contact:
    • New Jersey
      • Teaneck, New Jersey, United States, 07666
        • Recruiting
        • NJRetina Care Center - Teaneck
        • Contact:
      • Toms River, New Jersey, United States, 08755
        • Recruiting
        • NJ Retina - Toms River
        • Contact:
    • New York
      • Rochester, New York, United States, 14620
        • Recruiting
        • Retina Associates of Western New York
        • Contact:
      • Westbury, New York, United States, 11590
        • Recruiting
        • VRCNY/Long Island Vitreoretinal Consultants
        • Contact:
    • North Carolina
      • Asheville, North Carolina, United States, 28803
        • Recruiting
        • Asheville Eye Associates - Regional Medical Park
        • Contact:
      • Wilmington, North Carolina, United States, 28401
        • Recruiting
        • Cape Fear Retinal Associates, PC
        • Contact:
      • Winston-Salem, North Carolina, United States, 27103
        • Recruiting
        • Piedmont Retina Specialists, P.A. - Winston-Salem Office
        • Contact:
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74114
        • Recruiting
        • Tulsa Retina Consultant
        • Contact:
    • Pennsylvania
      • Erie, Pennsylvania, United States, 16507
        • Recruiting
        • Erie Retina Research
        • Contact:
    • South Carolina
      • Beaufort, South Carolina, United States, 29902
        • Recruiting
        • Charleston Neuroscience Institute - Beaufort
        • Contact:
      • Greenville, South Carolina, United States, 29605
        • Recruiting
        • Retina Consultants of Carolina P.A
        • Contact:
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • Tennessee Retina
        • Contact:
    • Texas
      • Abilene, Texas, United States, 79606
        • Recruiting
        • Retina Research Institute of Texas Integrated Clinical Research
        • Contact:
      • Dallas, Texas, United States, 75231
        • Recruiting
        • Texas Retina Associates
        • Contact:
      • Houston, Texas, United States, 77479
        • Recruiting
        • Mt. Olympus Medical Research
        • Contact:
      • Katy, Texas, United States, 77494
        • Recruiting
        • Retina Consultants of Texas
        • Contact:
      • Plano, Texas, United States, 75075
        • Recruiting
        • Texas Retina Associates
        • Contact:
      • Schertz, Texas, United States, 78154
        • Recruiting
        • Retina Consultants of Texas
        • Contact:
    • Utah
      • Salt Lake City, Utah, United States, 84107
        • Recruiting
        • Retina Associates of Utah
        • Contact:
      • West Jordan, Utah, United States, 84088
        • Recruiting
        • Salt Lake Retina
        • Contact:
    • Virginia
      • Lynchburg, Virginia, United States, 24502
        • Recruiting
        • Piedmont Eye Center
        • Contact:
      • Warrenton, Virginia, United States, 20186
        • Recruiting
        • Virginia Retina Center
        • Contact:
    • Wisconsin
      • Appleton, Wisconsin, United States, 54914
        • Recruiting
        • Northeast Wisconsin Retina Associates
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Aflibercept
Drug: Aflibercept (2.0 mg)
Intravitreal Injection
Experimental: EYP-1901 2686 µg
EYP-1901
Drug: EYP-1901
Intravitreal Injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Average change in best corrected visual acuity (BCVA)
Time Frame: Weeks 52 and 56
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 Outcome Measures

Outcome Measure
Time Frame
Rate of injection burden
Time Frame: Week 56
Week 56

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

EyePoint Pharmaceuticals, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 16, 2026

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

October 1, 2028

Study Registration Dates

First Submitted

February 27, 2026

First Submitted That Met QC Criteria

February 27, 2026

First Posted (Actual)

March 4, 2026

Study Record Updates

Last Update Posted (Actual)

June 3, 2026

Last Update Submitted That Met QC Criteria

June 1, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EYP-1901-303

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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