NCT07449936Active, not recruitingPhase 3
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)
Source: ClinicalTrials.gov · Last updated 3 Nov 2026
Brief summary (registry, in English)
This is a phase 3 randomized, double -masked study comparing the efficacy of EYP-1901 against Aflibercept.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 240 (estimated)
- First submitted
- 27 Feb 2026
- Start date
- 16 Feb 2026
- Primary completion date
- 31 Oct 2027
- Lead sponsor
- EyePoint Pharmaceuticals, Inc.
- Diseases
- Diabetic eye disease
- NCT number
- NCT07449936
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 240
- From 16 Feb 2026 to the primary completion date, 31 Oct 2027
- 73 sites in 5 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- BCVA using ETDRS charts \<30 letters (20/250 Snellen equivalent) in the fellow eye.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (73)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Universitätsklinikum Carl Gustav Carus Dresden Coordinator of this site? Confirm its status | Dresden | Germany | Unknown status |
| Augenklinik Universitaetsmedizin der Johannes Gutenberg-Univ. Coordinator of this site? Confirm its status | Mainz | Germany | Unknown status |
| Shamir Medical Center Ophthalmology Out Patient Clinic Coordinator of this site? Confirm its status | Be’er Ya‘aqov | Israel | Unknown status |
| Bnai Zion Medical Center Coordinator of this site? Confirm its status | Haifa | Israel | Unknown status |
| Rambam Health Care Campus (RHCC) Coordinator of this site? Confirm its status | Haifa | Israel | Unknown status |
| Carmel Medical Center Coordinator of this site? Confirm its status | Haifa | Israel | Unknown status |
| Meir Medical Center Ophthalmology Department Coordinator of this site? Confirm its status | Kfar Saba | Israel | Unknown status |
| Rabin Medical Center Coordinator of this site? Confirm its status | Petah Tikva | Israel | Unknown status |
| Kaplan Medical Center Coordinator of this site? Confirm its status | Rehovot | Israel | Unknown status |
| The Tel-Aviv Sourasky Medical Centre Coordinator of this site? Confirm its status | Tel Aviv | Israel | Unknown status |
| OFTALMIKA Sp. z o.o Coordinator of this site? Confirm its status | Bydgoszcz | Poland | Unknown status |
| Oculomedica Sp. z o.o. Coordinator of this site? Confirm its status | Bydgoszcz | Poland | Unknown status |
| Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie Coordinator of this site? Confirm its status | Lublin | Poland | Unknown status |
| Centrum Diagnostyki i Mikrochirurgii Oka-Lens Sp. z o.o. Coordinator of this site? Confirm its status | Olsztyn | Poland | Unknown status |
| Centrum Medyczne UNO-MED Coordinator of this site? Confirm its status | Tarnów | Poland | Unknown status |
| Warszawski Szpital Okulistyczny Coordinator of this site? Confirm its status | Warsaw | Poland | Unknown status |
| Fakultna nemocnica s poliklinikou F.D.Roosevelta Banska Bystrica Coordinator of this site? Confirm its status | Banská Bystrica | Slovakia | Unknown status |
| Oftalmocentrum Betliarska Coordinator of this site? Confirm its status | Bratislava | Slovakia | Unknown status |
| Nemocnica Poprad Coordinator of this site? Confirm its status | Poprad | Slovakia | Unknown status |
| Nemocnica s poliklinikou Trebisov a.s. Coordinator of this site? Confirm its status | Trebišov | Slovakia | Unknown status |
| Retina Research Institute of Texas Integrated Clinical Research Coordinator of this site? Confirm its status | Abilene | United States | Unknown status |
| Retina Consultants of Hawaii Coordinator of this site? Confirm its status | ‘Aiea | United States | Unknown status |
| Northeast Wisconsin Retina Associates Coordinator of this site? Confirm its status | Appleton | United States | Unknown status |
| Asheville Eye Associates - Regional Medical Park Coordinator of this site? Confirm its status | Asheville | United States | Unknown status |
| California Retina Consultants Coordinator of this site? Confirm its status | Bakersfield | United States | Unknown status |
| Johns Hopkins Medicine - The Johns Hopkins Hospital Campus - Wilmer Eye Institute Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
| Charleston Neuroscience Institute - Beaufort Coordinator of this site? Confirm its status | Beaufort | United States | Unknown status |
| Advanced Research LLC Sibia Eye Institute Coordinator of this site? Confirm its status | Boynton Beach | United States | Unknown status |
| Midwest Eye Institute - Carmel Coordinator of this site? Confirm its status | Carmel | United States | Unknown status |
| Retina Group of Washington Coordinator of this site? Confirm its status | Chevy Chase | United States | Unknown status |
| Retina Consultants of Southern Colorado Coordinator of this site? Confirm its status | Colorado Springs | United States | Unknown status |
| Texas Retina Associates Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| Advance Medical Research Group, Inc Coordinator of this site? Confirm its status | Deerfield Beach | United States | Unknown status |
| The Retina Partners Coordinator of this site? Confirm its status | Encino | United States | Unknown status |
| Erie Retina Research Coordinator of this site? Confirm its status | Erie | United States | Unknown status |
| Global Research Management, Inc Coordinator of this site? Confirm its status | Glendale | United States | Unknown status |
| Retina Associates of Michigan Coordinator of this site? Confirm its status | Grand Blanc | United States | Unknown status |
| Foundation for Vision Research Coordinator of this site? Confirm its status | Grand Rapids | United States | Unknown status |
| Retina Consultants of Carolina, P.A. Coordinator of this site? Confirm its status | Greenville | United States | Unknown status |
| Cumberland Valley Retina Consultants Coordinator of this site? Confirm its status | Hagerstown | United States | Unknown status |
| Mt Olympus Medical Research Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Retina Consultants of Texas Coordinator of this site? Confirm its status | Katy | United States | Unknown status |
| Colorado Retina Associates Coordinator of this site? Confirm its status | Lakewood | United States | Unknown status |
| Piedmont Eye Center Coordinator of this site? Confirm its status | Lynchburg | United States | Unknown status |
| Georgia Retina Coordinator of this site? Confirm its status | Marietta | United States | Unknown status |
| Northern California Retina Vitreous Associates Medical Group INC. Coordinator of this site? Confirm its status | Mountain View | United States | Unknown status |
| Tennessee Retina Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| Eye Associates of Pinellas Coordinator of this site? Confirm its status | Pinellas Park | United States | Unknown status |
| Red River Research Partners Coordinator of this site? Confirm its status | Plainfield | United States | Unknown status |
| Texas Retina Associates Coordinator of this site? Confirm its status | Plano | United States | Unknown status |
| Retina Consultants of San Diego Coordinator of this site? Confirm its status | Poway | United States | Unknown status |
| California Eye Specialists Medical Group, Inc. Coordinator of this site? Confirm its status | Redlands | United States | Unknown status |
| Sierra Eye Associates Coordinator of this site? Confirm its status | Reno | United States | Unknown status |
| Retina Associates of Western New York Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
| Retinal Consultants Medical Group - Parkcenter Drive Coordinator of this site? Confirm its status | Sacramento | United States | Unknown status |
| Retinal Consultants Medical Group Coordinator of this site? Confirm its status | Sacramento | United States | Unknown status |
| Retina Associates of Utah Coordinator of this site? Confirm its status | Salt Lake City | United States | Unknown status |
| Retina Consultants of Texas Coordinator of this site? Confirm its status | Schertz | United States | Unknown status |
| New England Retina Consultants Coordinator of this site? Confirm its status | Springfield | United States | Unknown status |
| Retina Vitreous Associates of Florida - Saint Petersburg Coordinator of this site? Confirm its status | St. Petersburg | United States | Unknown status |
| Southern Vitreoretinal Associates Coordinator of this site? Confirm its status | Tallahassee | United States | Unknown status |
| NJRetina Care Center - Teaneck Coordinator of this site? Confirm its status | Teaneck | United States | Unknown status |
| NJ Retina - Toms River Coordinator of this site? Confirm its status | Toms River | United States | Unknown status |
| Retina Specialists - Towson Coordinator of this site? Confirm its status | Towson | United States | Unknown status |
| Tulsa Retina Consultant Coordinator of this site? Confirm its status | Tulsa | United States | Unknown status |
| Tyler Retina Consultants Coordinator of this site? Confirm its status | Tyler | United States | Unknown status |
| Virginia Retina Center Coordinator of this site? Confirm its status | Warrenton | United States | Unknown status |
| Retina Specialists of Tampa Coordinator of this site? Confirm its status | Wesley Chapel | United States | Unknown status |
| VRCNY/Long Island Vitreoretinal Consultants Coordinator of this site? Confirm its status | Westbury | United States | Unknown status |
| Salt Lake Retina Coordinator of this site? Confirm its status | West Jordan | United States | Unknown status |
| Haik Humble Eye Center Coordinator of this site? Confirm its status | West Monroe | United States | Unknown status |
| Cape Fear Retinal Associates, PC Coordinator of this site? Confirm its status | Wilmington | United States | Unknown status |
| Piedmont Retina Specialists, P.A. - Winston-Salem Office Coordinator of this site? Confirm its status | Winston-Salem | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.