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

May 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

  • United States
    • Arizona
      • Gilbert, Arizona, United States, 85297
        • Recruiting
        • Associated Retina Consultans
        • Contact:
      • Phoenix, Arizona, United States, 85020
        • Recruiting
        • Associated Retina Consultants - Phoenix
        • Contact:
      • Phoenix, Arizona, United States, 85050
        • Recruiting
        • Phoenix Retina Clinical Trials, LLC - North Phoenix
        • Contact:
      • Scottsdale, Arizona, United States, 85255
        • Recruiting
        • Retina Macula Institute of Arizona
        • Contact:
    • California
      • Beverly Hills, California, United States, 90211
        • Recruiting
        • Retina Vitreous Associates Medical Group
        • Contact:
      • Fullerton, California, United States, 92835
        • Recruiting
        • Retina Consultants of Orange County
        • Contact:
      • Long Beach, California, United States, 90807
        • Recruiting
        • South Coast Retina Center
        • Contact:
      • Modesto, California, United States, 95356
        • Recruiting
        • Retinal Consultants Medical Group - Modesto
        • Contact:
      • Oakland, California, United States, 94611
        • Recruiting
        • Kaiser Permanente
        • Contact:
      • Redlands, California, United States, 92374
        • Recruiting
        • Retina Consultants of Southern California
        • Contact:
      • Walnut Creek, California, United States, 94598
        • Recruiting
        • Bay Area Retina Associates
        • Contact:
    • Colorado
      • Arvada, Colorado, United States, 80002
        • Recruiting
        • Retina Specialists of Colorado - Arvada
        • Contact:
    • Connecticut
      • Danbury, Connecticut, United States, 06810
        • Recruiting
        • Connecticut Eye Consultants, P.C.
        • Contact:
      • Greenwich, Connecticut, United States, 06830
        • Recruiting
        • Coastal Eye Surgeons, LLC
        • Contact:
      • Waterford, Connecticut, United States, 06385
        • Recruiting
        • Retina Group of New England, PC
        • Contact:
    • Florida
      • Fort Lauderdale, Florida, United States, 33308
        • Recruiting
        • Retina Group of Florida - Fort Lauderdale
        • Contact:
      • Pensacola, Florida, United States, 32503
        • Recruiting
        • Retina Specialty Institute
        • Contact:
      • Plantation, Florida, United States, 33324
        • Recruiting
        • Fort Lauderdale Eye Institute
        • Contact:
      • South Miami, Florida, United States, 33143
        • Recruiting
        • MedEye Associates
        • Contact:
      • St. Petersburg, Florida, United States, 33711
        • Recruiting
        • Retina Vitreous Associates of Florida - Saint Petersburg
        • Contact:
      • Tampa, Florida, United States, 33617
        • Recruiting
        • Retina Vitreous Associates of Florida
        • Contact:
    • Illinois
      • Elmhurst, Illinois, United States, 60126
        • Recruiting
        • Retina Associates
        • Contact:
      • Lemont, Illinois, United States, 60439
        • Recruiting
        • University Retina and Macula Associates
        • Contact:
      • Oak Park, Illinois, United States, 60304
        • Recruiting
        • Illinois Retina Associates, S.C.
        • Contact:
    • Indiana
      • Carmel, Indiana, United States, 46032
        • Recruiting
        • Associated Vitreoretinal & Uveitis Consultants - Carmel
        • Contact:
    • Kentucky
      • Louisville, Kentucky, United States, 40206
        • Recruiting
        • The Eye Care Institute
        • Contact:
    • Maryland
      • Hagerstown, Maryland, United States, 21740
        • Recruiting
        • Mid Atlantic Retina Specialists - Hagerstown
        • Contact:
    • Missouri
      • St Louis, Missouri, United States, 63128
        • Recruiting
        • The Retina Institute
        • Contact:
    • New Jersey
      • Bloomfield, New Jersey, United States, 07003
        • Recruiting
        • Retina Center of New Jersey
        • Contact:
    • New Mexico
      • Albuquerque, New Mexico, United States, 87109
        • Recruiting
        • Vision Research Center at Eye Associates of New Mexico
        • Contact:
    • New York
      • Liverpool, New York, United States, 13088
        • Recruiting
        • Retina Vitreous Surgeons of CNY, PC
        • Contact:
    • North Carolina
      • Hickory, North Carolina, United States, 28602
        • Recruiting
        • Graystone Eye - Hickory Office
        • Contact:
      • Wake Forest, North Carolina, United States, 27587
        • Recruiting
        • North Carolina Retina Associates
        • Contact:
    • Oklahoma
      • Edmond, Oklahoma, United States, 73013
        • Recruiting
        • Retina Vitreous Center, PLLC
        • Contact:
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Recruiting
        • Verum Research, LLC
        • Contact:
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Recruiting
        • Wills Eye Hospital
        • Contact:
    • South Carolina
      • Florence, South Carolina, United States, 29501
        • Recruiting
        • Carolinas Centers for Sight, P.C. - Florence Campus
        • Contact:
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • Recruiting
        • Charles Retina Institute
        • Contact:
    • Texas
      • Austin, Texas, United States, 78750
        • Recruiting
        • Austin Clinical Research LLC
        • Contact:
      • Bellaire, Texas, United States, 77401
        • Recruiting
        • Retina Consultants of Texas
        • Contact:
      • Bellaire, Texas, United States, 77401
        • Recruiting
        • Retina and Vitreous of Texas
        • Contact:
      • San Antonio, Texas, United States, 78215
        • Recruiting
        • San Antonio Eye Center
        • Contact:
      • San Antonio, Texas, United States, 78240
        • Recruiting
        • Retina Associates of South Texas
        • Contact:
      • The Woodlands, Texas, United States, 77384
        • Recruiting
        • Retina Consultants of Texas
        • Contact:
      • Tyler, Texas, United States, 75703
        • Recruiting
        • Tyler Retina Consultants
        • Contact:
      • Willow Park, Texas, United States, 76087
        • Recruiting
        • Strategic Clinical Research Group, LLC
        • Contact:
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Recruiting
        • The Retina Group of Washington
        • Contact:
    • Wisconsin
      • Wausau, Wisconsin, United States, 54403

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 9, 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)

May 6, 2026

Last Update Submitted That Met QC Criteria

May 1, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EYP-1901-304

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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