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  4. 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)

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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)

Status: Recruiting
Location: See all (39) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

This is a phase 3 randomized, double -masked study comparing the efficacy of EYP-1901 against Aflibercept.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
California
California Retina Consultants
RECRUITING
Bakersfield
The Retina Partners
RECRUITING
Encino
Global Research Management, Inc.
RECRUITING
Glendale
Northern California Retina Vitreous Associates Medical Group INC.
RECRUITING
Mountain View
Retina Consultants of San Diego
RECRUITING
Poway
California Eye Specialists Medical Group, Inc.
RECRUITING
Redlands
Retinal Consultants Medical Group
RECRUITING
Sacramento
Retinal Consultants Medical Group - Parkcenter Drive
RECRUITING
Sacramento
Colorado
Colorado Retina Associates
RECRUITING
Lakewood
Florida
Advance Medical Research Group, Inc
RECRUITING
Deerfield Beach
Eye Associates of Pinellas
RECRUITING
Pinellas Park
Southern Vitreoretinal Associates
RECRUITING
Tallahassee
Retina Specialists of Tampa
RECRUITING
Wesley Chapel
Georgia
Georgia Retina
RECRUITING
Marietta
Hawaii
Retina Consultants of Hawaii
RECRUITING
‘aiea
Illinois
Red River Research Partners
RECRUITING
Plainfield
Indiana
Midwest Eye Institute - Carmel
RECRUITING
Carmel
Louisiana
Haik Humble Eye Center
RECRUITING
West Monroe
Massachusetts
New England Retina Consultants
RECRUITING
Springfield
Michigan
Retina Associates of Michigan
RECRUITING
Grand Blanc
Foundation for Vision Research
RECRUITING
Grand Rapids
North Carolina
Asheville Eye Associates - Regional Medical Park
RECRUITING
Asheville
Cape Fear Retinal Associates, PC
RECRUITING
Wilmington
Piedmont Retina Specialists, P.A. - Winston-Salem Office
RECRUITING
Winston-salem
New Jersey
NJ Retina - Toms River
RECRUITING
Toms River
New York
Retina Associates of Western New York
RECRUITING
Rochester
VRCNY/Long Island Vitreoretinal Consultants
RECRUITING
Westbury
Oklahoma
Tulsa Retina Consultant
RECRUITING
Tulsa
Pennsylvania
Erie Retina Research
RECRUITING
Erie
South Carolina
Charleston Neuroscience Institute - Beaufort
RECRUITING
Beaufort
Tennessee
Tennessee Retina
RECRUITING
Nashville
Texas
Retina Research Institute of Texas Integrated Clinical Research
RECRUITING
Abilene
Texas Retina Associates
RECRUITING
Dallas
Mt. Olympus Medical Research
RECRUITING
Houston
Retina Consultants of Texas
RECRUITING
Katy
Texas Retina Associates
RECRUITING
Plano
Retina Consultants of Texas
RECRUITING
Schertz
Utah
Salt Lake Retina
RECRUITING
West Jordan
Virginia
Piedmont Eye Center
RECRUITING
Lynchburg
Contact Information
Primary
Ramiro Ribeiro, MD, PhD
rribeiro@eyepoint.bio
833-393-7646
Time Frame
Start Date: 2026-02-16
Estimated Completion Date: 2028-10
Participants
Target number of participants: 240
Treatments
Experimental: EYP-1901 2686 µg
EYP-1901
Active_comparator: Aflibercept
Related Therapeutic Areas
Diabetic Macular Edema (DME)
Late-Onset Retinal Degeneration
Age-Related Macular Degeneration (ARMD)
Sponsors
Leads: EyePoint Pharmaceuticals, Inc.

This content was sourced from clinicaltrials.gov

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