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

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

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Key information

Conditions

Diabetic Macular Edema DME Diabetic Macular Edema (DME)

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Universitatsklinikum Carl Gustav Carus Dresden, Dresden, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

EYP-1901

Drug

Intravitreal Injection

Aflibercept (2.0 mg)

Drug

Intravitreal Injection

Primary outcomes

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

Secondary outcomes

Rate of injection burden

Time frame: Week 56

Study contacts

Contact information is provided by the study sponsor or research team.

Ramiro Ribeiro, MD, PhD

CONTACT

[email protected]

833-393-7646

Sponsors and collaborators

Lead sponsor

EyePoint Pharmaceuticals, Inc.

Industry

Registry information

Official study title

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)

Acronym: DME

Important dates

Study start: 2026
Primary completion: 2027
Study completion: 2028
First posted: Mar 4, 2026
Registry last updated: Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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