A 2-year Phase 3, Multicenter, Prospective, Randomized, Double-Masked, Parallel-Group Study of EYP-1901, a Tyrosine Kinase Inhibitor (TKI), Compared to Aflibercept in Subjects With Wet AMD

Status: Active_not_recruiting
Location: See all (84) 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: 50
Healthy Volunteers: f
View:

• Previously treated or treatment naïve patients with a documented diagnosis of wAMD in the study eye, with onset of disease that began at any time prior to the Screening Visit.

• Best Corrected Visual Acuity (BCVA) by Early Treatment Diabetic Retinopathy Study (ETDRS) letter score between 78 to 35 letters (approximately 20/32 to 20/200 Snellen equivalent) in the study eye at the Screening Visit and on Baseline (Day 1).

• For previously-treated subjects, must have been treated with at least 2 anti-VEGF IVT injections (i.e., aflibercept 2 mg, aflibercept 8 mg, bevacizumab, ranibizumab, or faricimab) in the previous 6 months for wAMD per standard of care in the study eye prior to the Screening Visit.

Locations
United States
Arkansas
Retina Partners of Northwest Arkansas
Springdale
Arizona
Retinal Research Institute, LLC
Phoenix
California
California Retina Consultants
Bakersfield
Retina Vitreous Associates Medical Group
Beverly Hills
Macula and Retina Institute
Glendale
Gavin Herbert Eye Institute
Irvine
Retina Consultants San Diego
Poway
Retina Consultants of Southern California
Redlands
Retinal Consultants Medical Group
Sacramento
West Coast Retina Medical Group
San Francisco
Bay Area Retina Associates
Walnut Creek
American Institute of Research
Whittier
Colorado
RSC Research, PLLC
Denver
Eye Center of Northern Colorado, PC
Fort Collins
Advanced Vision Institute
Longmont
Connecticut
Connecticut Eye Consultants, P.C.
Danbury
SightSera Clinical Research LLC
Greenwich
Retina Group of New England, PC
Waterford
Florida
Advanced Research, LLC
Deerfield Beach
Vitreo Retinal Associates
Gainesville
Florida Retina Consultants
Lakeland
Florida Retina Institute
Orlando
Retina Specialty Institute
Pensacola
Eye Associates of Pinellas
Pinellas Park
Retina Group of Florida
Sarasota
MedEye Associates
South Miami
Retina Specialists of Tampa
Tampa
Retina Vitreous Associates of Florida
Tampa
Center for Retina & Macular Disease
Winter Haven
Georgia
Gerogia Retina
Marietta
Hawaii
Retina Consultants of Hawaii
‘aiea
Illinois
Retina Associates
Elmhurst
University Retina and Macula Associates
Lemont
Indiana
Midwest Eye Institute
Carmel
Kansas
Retina Associates LLC
Lenexa
Massachusetts
Ophthalmic Consultants of Boston OCB - Boston
Boston
New England Retina Consultants
Springfield
Maryland
The Retina Care Center
Baltimore
Retina Groups of Washington
Chevy Chase
Cumberland Valley Retina Consultants
Hagerstown
Retina Specialists
Towson
Maine
Maine Eye Center
Portland
Michigan
Retina Associates of Michigan
Grand Blanc
Foundation for Vision Research
Grand Rapids
Missouri
The Retina Institute
St Louis
Mississippi
Deep Blue Retina Clinical Research PLLC
Southaven
North Carolina
Western Carolina Retinal Associates, PA
Asheville
Cape Fear Retinal Associates, PC
Wilmington
Piedmont Retina Specialists, P.A. - Winston-Salem Office
Winston-salem
New Jersey
NJ Retina
Teaneck
NJ Retina
Toms River
New Mexico
Vision Research Center at Eye Associates of New Mexico
Albuquerque
Nevada
Sierra Eye Associates
Reno
New York
Retina Vitreous Surgeons of CNY, PC
Liverpool
Retina Associates of Western NY, PC
Rochester
Retina Consultants PLLC
Slingerlands
Ohio
Midwest Retina, Inc.
Dublin
Oklahoma
Tulsa Retina Consultant
Tulsa
Oregon
Verum Research LLC
Eugene
Pennsylvania
Erie Retina Research
Erie
Eye Care Specialists - Kingston Location
Kingston
South Carolina
Retina Consultants
Charleston
Palmetto Retina Center
Florence
Retina Consultants of Carolina P.A
Greenville
Tennessee
Charles Retina Institute
Germantown
Texas
Retina Research Institute of Texas Integrated Clinical Research
Abilene
Retina and Vitreous of Texas
Bellaire
Retina Consultants of Texas (Retina Consultants of Houston) - Woodlands
Bellaire
Texas Retina Associates
Dallas
Houston Eye Associates
Houston
Texas Retina Associates
Plano
Retinal Consultants of Texas
San Antonio
San Antonio Eye Center
San Antonio
Retina Center of Texas
Southlake
Retina Consultants of Texas
The Woodlands
Tyler Retina Consultants
Tyler
Strategic Clinical Research Group, LLC
Willow Park
Utah
Retina Associates of Utah
Salt Lake City
Rocky Mountain Retina Consultants
Salt Lake City
Salt Lake Retina
West Jordan
Virginia
The Retina Group of Washington
Fairfax
Piedmont Eye Center
Lynchburg
Retina Associates, P.C.
Winchester
Wisconsin
University of Wisconsin School of Medicine and Public Health (UWSMPH)
Madison
Time Frame
Start Date: 2024-10-22
Completion Date: 2027-08
Participants
Target number of participants: 400
Treatments
Experimental: EYP-1901 2686 µg
EYP-1901
Active_comparator: Aflibercept
Sponsors
Leads: EyePoint Pharmaceuticals, Inc.

This content was sourced from clinicaltrials.gov