CAPRI: 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
Associated Retina Consultans
Gilbert, Arizona 85297
Gilbert, Arizona 85297
Associated Retina Consultants - Phoenix
Phoenix, Arizona 85020
Phoenix, Arizona 85020
Phoenix Retina Clinical Trials, LLC - North Phoenix
Phoenix, Arizona 85050
Phoenix, Arizona 85050
Retina Macula Institute of Arizona
Scottsdale, Arizona 85255
Scottsdale, Arizona 85255
Retina Vitreous Associates Medical Group
Beverly Hills, California 90211
Beverly Hills, California 90211
South Coast Retina Center
Long Beach, California 90807
Long Beach, California 90807
Retinal Consultants Medical Group - Modesto
Modesto, California 95356
Modesto, California 95356
Retina Consultants of Southern California
Redlands, California 92374
Redlands, California 92374
Bay Area Retina Associates
Walnut Creek, California 94598
Walnut Creek, California 94598
Retina Specialists of Colorado - Arvada
Arvada, Colorado 80002
Arvada, Colorado 80002
Connecticut Eye Consultants, P.C.
Danbury, Connecticut 06810
Danbury, Connecticut 06810
Coastal Eye Surgeons, LLC
Greenwich, Connecticut 06830
Greenwich, Connecticut 06830
Retina Group of New England, PC
Waterford, Connecticut 06385
Waterford, Connecticut 06385
Retina Group of Florida - Fort Lauderdale
Fort Lauderdale, Florida 33308
Fort Lauderdale, Florida 33308
Retina Specialty Institute
Pensacola, Florida 32503
Pensacola, Florida 32503
Fort Lauderdale Eye Institute
Plantation, Florida 33324
Plantation, Florida 33324
Retina Vitreous Associates of Florida - Saint Petersburg
St. Petersburg, Florida 33711
St. Petersburg, Florida 33711
Retina Vitreous Associates of Florida
Tampa, Florida 33617
Tampa, Florida 33617
Retina Associates
Elmhurst, Illinois 60126
Elmhurst, Illinois 60126
Illinois Retina Associates, S.C.
Oak Park, Illinois 60304
Oak Park, Illinois 60304
Associated Vitreoretinal & Uveitis Consultants - Carmel
Carmel, Indiana 46032
Carmel, Indiana 46032
The Eye Care Institute
Louisville, Kentucky 40206
Louisville, Kentucky 40206
Mid Atlantic Retina Specialists - Hagerstown
Hagerstown, Maryland 21740
Hagerstown, Maryland 21740
Retina Center of New Jersey
Bloomfield, New Jersey 07003
Bloomfield, New Jersey 07003
Retina Vitreous Surgeons of CNY, PC
Liverpool, New York 13088
Liverpool, New York 13088
Graystone Eye - Hickory Office
Hickory, North Carolina 28602
Hickory, North Carolina 28602
North Carolina Retina Associates
Wake Forest, North Carolina 27587
Wake Forest, North Carolina 27587
Verum Research, LLC
Eugene, Oregon 97401
Eugene, Oregon 97401
Wills Eye Hospital
Philadelphia, Pennsylvania 19107
Philadelphia, Pennsylvania 19107
Carolinas Centers for Sight, P.C. - Florence Campus
Florence, South Carolina 29501
Florence, South Carolina 29501
Charles Retina Institute
Germantown, Tennessee 38138
Germantown, Tennessee 38138
Austin Clinical Research LLC
Austin, Texas 78750
Austin, Texas 78750
Retina Consultants of Texas
Bellaire, Texas 77401
Bellaire, Texas 77401
San Antonio Eye Center
San Antonio, Texas 78215
San Antonio, Texas 78215
Retina Associates of South Texas
San Antonio, Texas 78240
San Antonio, Texas 78240
Retina Consultants of Texas
The Woodlands, Texas 77384
The Woodlands, Texas 77384
Tyler Retina Consultants
Tyler, Texas 75703
Tyler, Texas 75703
Strategic Clinical Research Group, LLC
Willow Park, Texas 76087
Willow Park, Texas 76087
More Details
- Status
- Recruiting
- Sponsor
- EyePoint Pharmaceuticals, Inc.