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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
240

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 16, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 27, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 27, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 4, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 3, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 1, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

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