COMO: A Phase 3 Randomized, Double-Masked Study Comparing the Efficacy of EYP-1901 Against Aflibercept in DME
Part of paid clinical trials in Bakersfield, California.
- Sponsor
- EyePoint Pharmaceuticals, Inc.
- Study ID
- NCT07449936
- Phase
- PHASE3
- Status
- Active Not Recruiting
Conditions
- DME
- Diabetic Macular Edema
- Diabetic Macular Edema (DME)
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- EYP-1901 — DRUGIntravitreal Injection
- Aflibercept (2.0 mg) — DRUGIntravitreal Injection
Study Details
This is a phase 3 randomized, double -masked study comparing the efficacy of EYP-1901 against Aflibercept.
Key Dates
- First listed
- Mar 4, 2026
- Start date
- Feb 16, 2026
- Status verified
- Sep 2026
- Primary completion
- Oct 31, 2027
- Completion
- Oct 31, 2028
Study Design
- Enrollment
- 240 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: EYP-1901 2686 µgEYP-1901
- Active Comparator: Aflibercept
Primary Outcome Measure
Average change in best corrected visual acuity (BCVA) [ Time Frame: Weeks 52 and 56 ]
Locations (53)
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California Retina Consultants· Bakersfield, CAThe Retina Partners· Encino, CAGlobal Research Management, Inc.· Glendale, CANorthern California Retina Vitreous Associates Medical Group INC.· Mountain View, CARetina Consultants of San Diego· Poway, CACalifornia Eye Specialists Medical Group, Inc.· Redlands, CA
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