Clinical Trials in the USA / NCT07449936
Active, not recruiting
Phase 3
COMO: A Phase 3 Randomized, Double-Masked Study Comparing the Efficacy of EYP-1901 Against Aflibercept in DME
NCT07449936 · tracked via the Priya Life Science USA tracker
Condition(s) studied
Diabetic Macular EdemaDMEDiabetic Macular Edema (DME)
Investigational drug(s) / intervention(s)
EYP-1901: Intravitreal Injection
Aflibercept (2.0 mg): Intravitreal Injection
Study summary
This is a phase 3 randomized, double -masked study comparing the efficacy of EYP-1901 against Aflibercept.
Eligibility
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.
Primary outcome measure(s)
- 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
Trial sites (73)
| Facility | City | Region | Status |
|---|---|---|---|
| California Retina Consultants | Bakersfield | California | |
| The Retina Partners | Encino | California | |
| Global Research Management, Inc. | Glendale | California | |
| Northern California Retina Vitreous Associates Medical Group INC. | Mountain View | California | |
| Retina Consultants of San Diego | Poway | California | |
| California Eye Specialists Medical Group, Inc. | Redlands | California | |
| Retinal Consultants Medical Group - Parkcenter Drive | Sacramento | California | |
| Retinal Consultants Medical Group | Sacramento | California | |
| Retina Consultants of Southern Colorado | Colorado Springs | Colorado | |
| Colorado Retina Associates | Lakewood | Colorado | |
| Advanced Research LLC Sibia Eye Institute | Boynton Beach | Florida | |
| Advance Medical Research Group, Inc | Deerfield Beach | Florida | |
| Eye Associates of Pinellas | Pinellas Park | Florida | |
| Retina Vitreous Associates of Florida - Saint Petersburg | St. Petersburg | Florida | |
| Southern Vitreoretinal Associates | Tallahassee | Florida | |
| Retina Specialists of Tampa | Wesley Chapel | Florida | |
| Georgia Retina | Marietta | Georgia | |
| Retina Consultants of Hawaii | ‘Aiea | Hawaii | |
| Red River Research Partners | Plainfield | Illinois | |
| Midwest Eye Institute - Carmel | Carmel | Indiana | |
| Haik Humble Eye Center | West Monroe | Louisiana | |
| Johns Hopkins Medicine - The Johns Hopkins Hospital Campus - Wilmer Eye Institute | Baltimore | Maryland | |
| Retina Group of Washington | Chevy Chase | Maryland | |
| Cumberland Valley Retina Consultants | Hagerstown | Maryland | |
| Retina Specialists - Towson | Towson | Maryland | |
| New England Retina Consultants | Springfield | Massachusetts | |
| Retina Associates of Michigan | Grand Blanc | Michigan | |
| Foundation for Vision Research | Grand Rapids | Michigan | |
| Sierra Eye Associates | Reno | Nevada | |
| NJRetina Care Center - Teaneck | Teaneck | New Jersey | |
| NJ Retina - Toms River | Toms River | New Jersey | |
| Retina Associates of Western New York | Rochester | New York | |
| VRCNY/Long Island Vitreoretinal Consultants | Westbury | New York | |
| Asheville Eye Associates - Regional Medical Park | Asheville | North Carolina | |
| Cape Fear Retinal Associates, PC | Wilmington | North Carolina | |
| Piedmont Retina Specialists, P.A. - Winston-Salem Office | Winston-Salem | North Carolina | |
| Tulsa Retina Consultant | Tulsa | Oklahoma | |
| Erie Retina Research | Erie | Pennsylvania | |
| Charleston Neuroscience Institute - Beaufort | Beaufort | South Carolina | |
| Retina Consultants of Carolina P.A | Greenville | South Carolina |
+ 33 more sites — see the full list on the official registry below.
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07449936 on ClinicalTrials.gov ↗ ← All trials in the USA