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)

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07449936

Acronym

DME

Enrollment

240

Registered

2026-03-04

Start date

2026-02-26

Completion date

2028-08-01

Last updated

2026-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Macular Edema, DME, Diabetic Macular Edema (DME)

Keywords

EyePoint, EYP-1901, Tyrosine Kinase Inhibitor, Diabetic Macular Edema

Brief summary

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

Interventions

DRUGEYP-1901

Intravitreal Injection

DRUGAflibercept (2.0 mg)

Intravitreal Injection

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
Average change in best corrected visual acuity (BCVA)	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

Measure	Time frame
Rate of injection burden	Week 56

Countries

United States

Contacts

CONTACTRamiro Ribeiro, MD, PhD

rribeiro@eyepoint.bio833-393-7646

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 17, 2026