RecruitingPhase 3NCT07449936
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)
Sponsor
EyePoint Pharmaceuticals, Inc.
Enrollment
240 participants
Start Date
Feb 16, 2026
Study Type
INTERVENTIONAL
Conditions
Summary
This is a phase 3 randomized, double -masked study comparing the efficacy of EYP-1901 against Aflibercept.
Eligibility
Min Age: 18 Years
Inclusion Criteria3
- 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 Criteria1
- BCVA using ETDRS charts <30 letters (20/250 Snellen equivalent) in the fellow eye.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
DRUGEYP-1901
Intravitreal Injection
DRUGAflibercept (2.0 mg)
Intravitreal Injection
Locations(46)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07449936
Related Trials
A Real-World Study to Gain Clinical Insights Into Faricimab (FaReal Study)
NCT0668081759 locations
CAPRI: A Phase 3 Randomized, Double-Masked Study Comparing the Efficacy of EYP-1901 Against Aflibercept in DME
NCT0744992348 locations
Clinical Study to Compare Efficacy and Safety of AVT29 and Eylea HD in Participants With Diabetic Macular Edema
NCT074891311 location
A Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of RO7823653 in Participants With Diabetic Macular Edema (DME)
NCT074255228 locations
Biomarkers in Diabetic Retinopathy Treated With Faricimab vs Biosimilar Ranibizumab
NCT075200451 location