Actively Recruiting
A Phase 3 Randomized, Double-Masked Study Comparing EYP-1901 and Aflibercept in Diabetic Macular Edema
Led by EyePoint Pharmaceuticals, Inc. · Updated on 2026-06-03
240
Participants Needed
65
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a phase 3 randomized, double-masked study to compare the effectiveness of EYP-1901, a tyrosine kinase inhibitor, against Aflibercept in patients with diabetic macular edema (DME). The study focuses on evaluating changes in best corrected visual acuity and injection burden over a one-year period. This trial is sponsored by EyePoint Pharmaceuticals, Inc. and aims to provide more treatment options for this eye condition. Participants will receive either EYP-1901 (2686 µg) or Aflibercept (2 mg) through intravitreal injections directly into the eye. The study is designed with parallel groups and uses random assignment to one of the two treatments. Both treatments will be administered under quadruple masking to maintain unbiased results. The main treatment period lasts for 56 weeks with monitoring of visual acuity and injection frequency. During the trial, participants will undergo assessments including measuring best corrected visual acuity (BCVA) at weeks 52 and 56 to evaluate changes. Researchers will also track the rate of injections to understand the treatment burden. Participants will be monitored regularly to ensure safety and adherence. The total participation time spans over one year, with scheduled visits for evaluations, injections, and safety checks.
CONDITIONS
Brief Title
COMO: A Phase 3 Randomized, Double-Masked Study Comparing the Efficacy of EYP-1901 Against Aflibercept in DME
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Previously treated or treatment naïve patients with documented macular edema associated with diabetic retinopathy in the study eye
- Best-corrected visual acuity (BCVA) ETDRS letter score of 35 to 78 letters (20/200 to 20/32 Snellen equivalent) in the study eye at screening and baseline
- For previously treated participants, at least 1 anti-VEGF injection in the past 12 months and the most recent injection must be at least 12 weeks before screening
You will not qualify if you...
- BCVA in the fellow eye less than 30 letters (20/250 Snellen equivalent)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 56 weeks
Participants receive intravitreal injections of either EYP-1901 or Aflibercept as part of the study treatment.
Regular visits for injections and assessments up to Week 56
Trial Site Locations
Total: 65 locations
1
California Retina Consultants
Bakersfield, California, United States, 93309
Actively Recruiting
2
The Retina Partners
Encino, California, United States, 91436
Actively Recruiting
3
Global Research Management, Inc.
Glendale, California, United States, 91204
Actively Recruiting
4
Northern California Retina Vitreous Associates Medical Group INC.
Mountain View, California, United States, 94040
Actively Recruiting
5
Retina Consultants of San Diego
Poway, California, United States, 92064
Actively Recruiting
6
California Eye Specialists Medical Group, Inc.
Redlands, California, United States, 92373
Actively Recruiting
7
Retinal Consultants Medical Group - Parkcenter Drive
Sacramento, California, United States, 95825
Actively Recruiting
8
Retinal Consultants Medical Group
Sacramento, California, United States, 95841
Actively Recruiting
9
Retina Consultants of Southern Colorado
Colorado Springs, Colorado, United States, 80909
Actively Recruiting
10
Colorado Retina Associates
Lakewood, Colorado, United States, 80228
Actively Recruiting
11
Advance Medical Research Group, Inc
Deerfield Beach, Florida, United States, 33064
Actively Recruiting
12
Eye Associates of Pinellas
Pinellas Park, Florida, United States, 33782
Actively Recruiting
13
Retina Vitreous Associates of Florida - Saint Petersburg
St. Petersburg, Florida, United States, 33711
Actively Recruiting
14
Southern Vitreoretinal Associates
Tallahassee, Florida, United States, 32308
Actively Recruiting
15
Retina Specialists of Tampa
Wesley Chapel, Florida, United States, 33544
Actively Recruiting
16
Georgia Retina
Marietta, Georgia, United States, 30060
Actively Recruiting
17
Retina Consultants of Hawaii
‘Aiea, Hawaii, United States, 96701
Actively Recruiting
18
Red River Research Partners
Plainfield, Illinois, United States, 60586
Actively Recruiting
19
Midwest Eye Institute - Carmel
Carmel, Indiana, United States, 11220
Actively Recruiting
20
Haik Humble Eye Center
West Monroe, Louisiana, United States, 71291
Actively Recruiting
21
Retina Group of Washington
Chevy Chase, Maryland, United States, 20815
Actively Recruiting
22
Cumberland Valley Retina Consultants
Hagerstown, Maryland, United States, 21740
Completed
23
Retina Specialists - Towson
Towson, Maryland, United States, 21204
Actively Recruiting
24
New England Retina Consultants
Springfield, Massachusetts, United States, 01107
Actively Recruiting
25
Retina Associates of Michigan
Grand Blanc, Michigan, United States, 48439
Actively Recruiting
26
Foundation for Vision Research
Grand Rapids, Michigan, United States, 49546
Actively Recruiting
27
Sierra Eye Associates
Reno, Nevada, United States, 89502
Actively Recruiting
28
NJRetina Care Center - Teaneck
Teaneck, New Jersey, United States, 07666
Actively Recruiting
29
NJ Retina - Toms River
Toms River, New Jersey, United States, 08755
Actively Recruiting
30
Retina Associates of Western New York
Rochester, New York, United States, 14620
Actively Recruiting
31
VRCNY/Long Island Vitreoretinal Consultants
Westbury, New York, United States, 11590
Actively Recruiting
32
Asheville Eye Associates - Regional Medical Park
Asheville, North Carolina, United States, 28803
Actively Recruiting
33
Cape Fear Retinal Associates, PC
Wilmington, North Carolina, United States, 28401
Actively Recruiting
34
Piedmont Retina Specialists, P.A. - Winston-Salem Office
Winston-Salem, North Carolina, United States, 27103
Actively Recruiting
35
Tulsa Retina Consultant
Tulsa, Oklahoma, United States, 74114
Actively Recruiting
36
Erie Retina Research
Erie, Pennsylvania, United States, 16507
Actively Recruiting
37
Charleston Neuroscience Institute - Beaufort
Beaufort, South Carolina, United States, 29902
Actively Recruiting
38
Retina Consultants of Carolina P.A
Greenville, South Carolina, United States, 29605
Actively Recruiting
39
Tennessee Retina
Nashville, Tennessee, United States, 37203
Actively Recruiting
40
Retina Research Institute of Texas Integrated Clinical Research
Abilene, Texas, United States, 79606
Actively Recruiting
41
Texas Retina Associates
Dallas, Texas, United States, 75231
Actively Recruiting
42
Mt. Olympus Medical Research
Houston, Texas, United States, 77479
Actively Recruiting
43
Retina Consultants of Texas
Katy, Texas, United States, 77494
Actively Recruiting
44
Texas Retina Associates
Plano, Texas, United States, 75075
Actively Recruiting
45
Retina Consultants of Texas
Schertz, Texas, United States, 78154
Actively Recruiting
46
Retina Associates of Utah
Salt Lake City, Utah, United States, 84107
Actively Recruiting
47
Salt Lake Retina
West Jordan, Utah, United States, 84088
Actively Recruiting
48
Piedmont Eye Center
Lynchburg, Virginia, United States, 24502
Actively Recruiting
49
Virginia Retina Center
Warrenton, Virginia, United States, 20186
Actively Recruiting
50
Northeast Wisconsin Retina Associates
Appleton, Wisconsin, United States, 54914
Actively Recruiting
51
Augenklinik Universitaetsmedizin der Johannes Gutenberg-Univ.
Mainz, Germany
Actively Recruiting
52
Shamir Medical Center Ophthalmology Out Patient Clinic
Be’er Ya‘aqov, Israel
Actively Recruiting
53
Bnai Zion Medical Center
Haifa, Israel
Actively Recruiting
54
Carmel Medical Center
Haifa, Israel
Actively Recruiting
55
Rambam Health Care Campus (RHCC)
Haifa, Israel
Actively Recruiting
56
Meir Medical Center Ophthalmology Department
Kfar Saba, Israel
Actively Recruiting
57
Rabin Medical Center
Petah Tikva, Israel
Actively Recruiting
58
Kaplan Medical Center
Rehovot, Israel
Actively Recruiting
59
The Tel-Aviv Sourasky Medical Centre
Tel Aviv, Israel
Actively Recruiting
60
OFTALMIKA Sp. z o.o
Bydgoszcz, Poland
Actively Recruiting
61
Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie
Lublin, Poland
Actively Recruiting
62
Centrum Diagnostyki i Mikrochirurgii Oka -LENS Sp. z o. o
Olsztyn, Poland
Actively Recruiting
63
Centrum Medyczne UNO-MED
Tarnów, Poland
Actively Recruiting
64
Warszawski Szpital Okulistyczny
Warsaw, Poland
Actively Recruiting
65
Nemocnica s poliklinikou Trebisov a.s.
Trebišov, Slovakia
Actively Recruiting
Research Team
R
Ramiro Ribeiro, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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