COMO: A Phase 3 Randomized, Double-Masked Study Comparing the Efficacy of EYP-1901 Against Aflibercept in DME
Purpose
This is a phase 3 randomized, double -masked study comparing the efficacy of EYP-1901 against Aflibercept.
Conditions
- Diabetic Macular Edema
- DME
- Diabetic Macular Edema (DME)
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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.
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental EYP-1901 2686 µg |
EYP-1901 |
|
|
Active Comparator Aflibercept |
|
Recruiting Locations
California Retina Consultants
Bakersfield, California 93309
Bakersfield, California 93309
The Retina Partners
Encino, California 91436
Encino, California 91436
Global Research Management, Inc.
Glendale, California 91204
Glendale, California 91204
Northern California Retina Vitreous Associates Medical Group INC.
Mountain View, California 94040
Mountain View, California 94040
Retina Consultants of San Diego
Poway, California 92064
Poway, California 92064
California Eye Specialists Medical Group, Inc.
Redlands, California 92373
Redlands, California 92373
Retinal Consultants Medical Group - Parkcenter Drive
Sacramento, California 95825
Sacramento, California 95825
Retinal Consultants Medical Group
Sacramento, California 95841
Sacramento, California 95841
Colorado Retina Associates
Lakewood, Colorado 80228
Lakewood, Colorado 80228
Advance Medical Research Group, Inc
Deerfield Beach, Florida 33064
Deerfield Beach, Florida 33064
Eye Associates of Pinellas
Pinellas Park, Florida 33782
Pinellas Park, Florida 33782
Southern Vitreoretinal Associates
Tallahassee, Florida 32308
Tallahassee, Florida 32308
Retina Specialists of Tampa
Wesley Chapel, Florida 33544
Wesley Chapel, Florida 33544
Georgia Retina
Marietta, Georgia 30060
Marietta, Georgia 30060
Retina Consultants of Hawaii
‘Aiea, Hawaii 96701
‘Aiea, Hawaii 96701
Red River Research Partners
Plainfield, Illinois 60586
Plainfield, Illinois 60586
Midwest Eye Institute - Carmel
Carmel, Indiana 11220
Carmel, Indiana 11220
Haik Humble Eye Center
West Monroe, Louisiana 71291
West Monroe, Louisiana 71291
New England Retina Consultants
Springfield, Massachusetts 01107
Springfield, Massachusetts 01107
Retina Associates of Michigan
Grand Blanc, Michigan 48439
Grand Blanc, Michigan 48439
Foundation for Vision Research
Grand Rapids, Michigan 49546
Grand Rapids, Michigan 49546
NJ Retina - Toms River
Toms River, New Jersey 08755
Toms River, New Jersey 08755
Retina Associates of Western New York
Rochester, New York 14620
Rochester, New York 14620
VRCNY/Long Island Vitreoretinal Consultants
Westbury, New York 11590
Westbury, New York 11590
Asheville Eye Associates - Regional Medical Park
Asheville, North Carolina 28803
Asheville, North Carolina 28803
Cape Fear Retinal Associates, PC
Wilmington, North Carolina 28401
Wilmington, North Carolina 28401
Piedmont Retina Specialists, P.A. - Winston-Salem Office
Winston-Salem, North Carolina 27103
Winston-Salem, North Carolina 27103
Tulsa Retina Consultant
Tulsa, Oklahoma 74114
Tulsa, Oklahoma 74114
Erie Retina Research
Erie, Pennsylvania 16507
Erie, Pennsylvania 16507
Charleston Neuroscience Institute - Beaufort
Beaufort, South Carolina 29902
Beaufort, South Carolina 29902
Tennessee Retina
Nashville, Tennessee 37203
Nashville, Tennessee 37203
Retina Research Institute of Texas Integrated Clinical Research
Abilene, Texas 79606
Abilene, Texas 79606
Texas Retina Associates
Dallas, Texas 75231
Dallas, Texas 75231
Mt. Olympus Medical Research
Houston, Texas 77479
Houston, Texas 77479
Retina Consultants of Texas
Katy, Texas 77494
Katy, Texas 77494
Texas Retina Associates
Plano, Texas 75075
Plano, Texas 75075
Retina Consultants of Texas
Schertz, Texas 78154
Schertz, Texas 78154
Salt Lake Retina
West Jordan, Utah 84088
West Jordan, Utah 84088
Piedmont Eye Center
Lynchburg, Virginia 24502
Lynchburg, Virginia 24502
More Details
- Status
- Recruiting
- Sponsor
- EyePoint Pharmaceuticals, Inc.