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

RECRUITINGPHASE3

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

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)

NCT07449936•EyePoint Pharmaceuticals, Inc.

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.

Locations (3)

Global Research Management, Inc.

Glendale, California, United States

Midwest Eye Institute - Carmel

Carmel, Indiana, United States

Mt. Olympus Medical Research

Houston, Texas, United States

Key Dates

Start Date

February 26, 2026

Primary Completion Date

August 1, 2027

Completion Date

August 1, 2028

Last Updated

March 16, 2026

Enrollment

240

ESTIMATED participants

Conditions

Diabetic Macular EdemaDMEDiabetic Macular Edema (DME)

Interventions

EYP-1901

DRUG

Aflibercept (2.0 mg)

DRUG

Contacts

Ramiro Ribeiro, MD, PhD

CONTACT

833-393-7646 rribeiro@eyepoint.bio

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

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 16, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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

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