A Phase 3, Multicenter, Double-Masked, Randomized, Parallel-Group Study to Evaluate the Efficacy and Safety of Intravitreal OTX-TKI (Axitinib Implant) in Subjects With Neovascular Age-Related Macular Degeneration (nAMD)
Status: Active_not_recruiting
Location: See all (108) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
Study to Evaluate the Efficacy and Safety of Intravitreal OTX-TKI (axitinib implant) in Subjects with Neovascular Age-Related Macular Degeneration
Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Healthy Volunteers: f
View:
• Treatment naïve for Neovascular Age-Related Macular Degeneration (nAMD) in either eye at screening.
• Are at least older than 50 years of age at Day 1.
• Have Best Corrected Visual Acuity (BCVA) of at least 84 Early Treatment Diabetic Retinopathy Study (ETDRS) letter score (approximate 20/20 Snellen equivalent) at Day 1; OR have an increase of at least 10 ETDRS letters of Best Corrected Visual Acuity (BCVA) from Screening (Visit 1) BCVA
Locations
United States
Arizona
Associated Retina Consultants - Gilbert
Gilbert
Associated Retina Consultants - Phoenix
Phoenix
Retinal Research Institute
Phoenix
Retina Macula Institute of Arizona
Scottsdale
California
CA CRC California Retina Consultants
Bakersfield
The Retina Partners - Encino
Encino
Retina Consultants of Orange County - Fullerton
Fullerton
Atlantis Eyecare
Huntington Beach
Lakeside Vision Center - Irvine
Irvine
Retina-Vitreous Associates Medical Group - Los Angeles
Los Angeles
CA RCMG Retinal Consultants Medical Group, Inc.
Modesto
Retina Sacramento MSO, LLC
Modesto
Kaiser Permanente Division of Research
Oakland
CA CRC California Retina Consultants
Oxnard
Stanford University School of Medicine, Byers Eye Institute
Palo Alto
AzulVision
Pasadena
Doheny Eye Center
Pasadena
Orange County Retina Medical Group
Santa Ana
California Retina Consultants (CRC) - Santa Barbara
Santa Barbara
Macula Retina Vitreous Center
Torrance
Bay Area Retina Associates, A Medical Group
Walnut Creek
Colorado
Retina Consultants of Southern Colorado - Colorado Springs
Colorado Springs
RSC Research, PLLC
Denver
Colorado Retina Associates (CRA) - Lakewood
Lakewood
Connecticut
Retina Group of New England, PC
Waterford
Florida
The Macula Center - Clearwater Office (Suncoast Retina Consultants, LLC)
Clearwater
Rand Eye Institute
Deerfield Beach
Speciality Retina Center
Deerfield Beach
Retina Group of Florida - Fort Lauderdale
Fort Lauderdale
Florida Retina Institute - Lake Mary
Lake Mary
Florida Retina Consultants - Lakeland
Lakeland
South Florida Retina Institute
Miami
Retina Specialty Institute - Pensacola
Pensacola
MedEye Associates - Miami
South Miami
Retina Vitreous Associates of Florida (RVA) - Saint Petersburg
St. Petersburg
Retina Associates of Florida LLC Tampa MacDill
Tampa
Retina Vitreous Associates of Florida - Tampa
Tampa
Georgia
Southeast Retina Center, P.C. - Augusta
Augusta
Iowa
Wolfe Eye Clinic
West Des Moines
Illinois
Illinois Eye and Ear Infirmary at UI Health UIC
Chicago
Illinois Retina Associates, S.C. - Lincoln Park
Chicago
University Retina and Macula Associates, P.C.
Oak Forest
Springfield Clinic
Springfield
Indiana
IN AVRUC Associated Vitreoretinal and Uveitis Consultants
Carmel
Retina Partners Midwest
Indianapolis
Maryland
The Wilmer Eye Institute
Baltimore
Cumberland Valley Retina Consultants
Hagerstown
Mid Atlantic Retina Specialists - Hagerstown
Hagerstown
Maine
Maine Eye Center - Marginal Way Campus
Portland
Michigan
Henry Ford Hospital
Detroit
Associated Retinal Consultants P.C. (ARC) - Royal Oak
Royal Oak
Minnesota
Retina Consultants of Minnesota
Edina
Missouri
Pepose Vision Institute
Chesterfield
Retina Research Institute, LLC
St Louis
Mississippi
Mississippi Baptist Medical Center
Jackson
North Carolina
Asheville Eye Associates (AEA) - Retinal Office
Asheville
Duke University Health System - Duke Eye Center Of North Durham
Durham
New Jersey
The Retina Center Of New Jersey, LLC - Bloomfield
Bloomfield
Nevada
Sierra Eye Associates
Reno
New York
Long Island Vitreoretinal Consultants (VRC) - Hauppauge
Hauppauge
Retina-Vitreous Surgeons of Central New York
Liverpool
NY LIVRC Long Island Vitreoretinal Consultants
Shirley
Ohio
Retina Associates of Cleveland, Inc. - Beachwood
Beachwood
Retina Associates of Cleveland
Cleveland
Retina Associates of Cleveland, Inc. - Youngstown
Youngstown
Pennsylvania
Erie Retina Research
Erie
South Carolina
Palmetto Retina Center
Aiken
Charleston Neuroscience Institute LLC - Beaufort
Beaufort
SC CNI Retina Consultants of Charleston
Beaufort
Charleston Neuroscience Institute LLC - Charleston
Charleston
Palmetto Retina Center
Florence
Charleston Neuroscience Institute
Ladson
Retina Consultants of Charleston - Mount Pleasant
Mt. Pleasant
Palmetto Retina Center
West Columbia
South Dakota
Black Hills Regional Eye Institute (BHREI)
Rapid City
Vance Thompson Vision
Sioux Falls
Tennessee
Charles Retina Institute PC
Germantown
Tennessee Retina, PC - Nashville - Centennial Professional Plaza Location
Nashville
Texas
West Texas Retina Consultants (WTRC) - Abilene (Ophthalmology Specialists of Texas, PA)
Abilene
Texas Retina Associates (TRA) - Arlington
Arlington
Austin Retina Associates, PLLC
Austin
Keystone Research
Austin
Retina Consultants of Austin PA (RCA) - Central Austin
Austin
Retina Research Center (RRC)
Austin
Retina Consultants of Texas Beaumont
Beaumont
Retina Group, Inc. d/b/a Retina Consultants of America (Retina Consultants of Texas)
Bellaire
Star Vision Consultants
Burleson
Texas Retina Center
Houston
Retina Consultants of Texas - Katy
Katy
Medical Center Ophthalmology Associates (MCOA) - Northwest Clinic Location
San Antonio
Retinal Consultants of Texas - San Antonio Medical Center
San Antonio
TX RCTX Retina Consultants of Texas
San Antonio
Retina Consultants of Houston
The Woodlands
Utah
Retina Associates of Utah, P.C - Intermountain Medical Center Location
Salt Lake City
Virginia
Wagner Macula & Retina Center - Norfolk, VA Office
Norfolk
Vistar Eye Center Vision and Surgery Specialists
Roanoke
Wisconsin
Eye Clinic of Wisconsin
Wausau
Other Locations
Argentina
Centro Oftalmologico Dr. Charles S.A
Buenos Aires
Fundacion Zambrano - Cirugia Ocular
Buenos Aires
Instituto Oftalmologico de Alta Complejidad
Buenos Aires
Organizacion Medica de Investigacion OMI
Buenos Aires
Centro Privado de Ojos Romagosa SA
Córdoba
Centrovision
Mendoza
Oftar Mendoza Srl Centro Privado de Oftalmologia
Mendoza
Buenos Aires Macula
Pilar
Oftalmologia Global
Rosario
Laser Vision Group
Santa Fe
Puerto Rico
Emanuelli research and development
Arecibo
Time Frame
Start Date: 2024-01-29
Completion Date: 2027-09-27
Participants
Target number of participants: 344
Treatments
Experimental: OTX-TKI (axitinib implant)
Other: Control
Related Therapeutic Areas
Sponsors
Leads: Ocular Therapeutix, Inc.
Collaborators: Fortrea, Duke University