Study to Evaluate the Efficacy and Safety of Intravitreal OTX-TKI (Ocular Therapeutix) (Axitinib Implant) in Subjects With Neovascular Age-Related Macular Degeneration
NCT ID: NCT06223958
Last Updated: 2025-04-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
344 participants
INTERVENTIONAL
2024-01-29
2027-09-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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OTX-TKI (axitinib implant)
OTX-TKI (axitinib implant)
Intravitreal Injection of OTX-TKI (axitinib implant)
Control
Aflibercept
Injection of 2mg (0.05mL) of aflibercept
Interventions
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OTX-TKI (axitinib implant)
Intravitreal Injection of OTX-TKI (axitinib implant)
Aflibercept
Injection of 2mg (0.05mL) of aflibercept
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* Have evidence of a scar, fibrosis, or atrophy of \> 50% of the total lesion in the study eye.
50 Years
ALL
No
Sponsors
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Fortrea
INDUSTRY
Duke University
OTHER
Ocular Therapeutix, Inc.
INDUSTRY
Responsible Party
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Locations
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Associated Retina Consultants - Gilbert
Gilbert, Arizona, United States
Associated Retina Consultants - Phoenix
Phoenix, Arizona, United States
Retinal Research Institute
Phoenix, Arizona, United States
Retina Macula Institute of Arizona
Scottsdale, Arizona, United States
CA CRC California Retina Consultants
Bakersfield, California, United States
The Retina Partners - Encino
Encino, California, United States
Retina Consultants of Orange County - Fullerton
Fullerton, California, United States
Atlantis Eyecare
Huntington Beach, California, United States
Lakeside Vision Center - Irvine
Irvine, California, United States
Retina-Vitreous Associates Medical Group - Los Angeles
Los Angeles, California, United States
CA RCMG Retinal Consultants Medical Group, Inc.
Modesto, California, United States
Retina Sacramento MSO, LLC
Modesto, California, United States
Kaiser Permanente Division of Research
Oakland, California, United States
CA CRC California Retina Consultants
Oxnard, California, United States
Stanford University School of Medicine, Byers Eye Institute
Palo Alto, California, United States
Doheny Eye Center
Pasadena, California, United States
AzulVision
Pasadena, California, United States
Orange County Retina Medical Group
Santa Ana, California, United States
California Retina Consultants (CRC) - Santa Barbara
Santa Barbara, California, United States
Macula Retina Vitreous Center
Torrance, California, United States
Bay Area Retina Associates, A Medical Group
Walnut Creek, California, United States
Retina Consultants of Southern Colorado - Colorado Springs
Colorado Springs, Colorado, United States
RSC Research, PLLC
Denver, Colorado, United States
Colorado Retina Associates (CRA) - Lakewood
Lakewood, Colorado, United States
Retina Group of New England, PC
Waterford, Connecticut, United States
The Macula Center - Clearwater Office (Suncoast Retina Consultants, LLC)
Clearwater, Florida, United States
Rand Eye Institute
Deerfield Beach, Florida, United States
Speciality Retina Center
Deerfield Beach, Florida, United States
Retina Group of Florida - Fort Lauderdale
Fort Lauderdale, Florida, United States
Florida Retina Institute - Lake Mary
Lake Mary, Florida, United States
Florida Retina Consultants - Lakeland
Lakeland, Florida, United States
South Florida Retina Institute
Miami, Florida, United States
Retina Specialty Institute - Pensacola
Pensacola, Florida, United States
MedEye Associates - Miami
South Miami, Florida, United States
Retina Vitreous Associates of Florida (RVA) - Saint Petersburg
St. Petersburg, Florida, United States
Retina Vitreous Associates of Florida - Tampa
Tampa, Florida, United States
Retina Associates of Florida LLC Tampa MacDill
Tampa, Florida, United States
Southeast Retina Center, P.C. - Augusta
Augusta, Georgia, United States
Illinois Eye and Ear Infirmary at UI Health UIC
Chicago, Illinois, United States
Illinois Retina Associates, S.C. - Lincoln Park
Chicago, Illinois, United States
University Retina and Macula Associates, P.C.
Oak Forest, Illinois, United States
Springfield Clinic
Springfield, Illinois, United States
IN AVRUC Associated Vitreoretinal and Uveitis Consultants
Carmel, Indiana, United States
Retina Partners Midwest
Indianapolis, Indiana, United States
Wolfe Eye Clinic
West Des Moines, Iowa, United States
Maine Eye Center - Marginal Way Campus
Portland, Maine, United States
The Wilmer Eye Institute
Baltimore, Maryland, United States
Mid Atlantic Retina Specialists - Hagerstown
Hagerstown, Maryland, United States
Cumberland Valley Retina Consultants
Hagerstown, Maryland, United States
Henry Ford Hospital
Detroit, Michigan, United States
Associated Retinal Consultants P.C. (ARC) - Royal Oak
Royal Oak, Michigan, United States
Retina Consultants of Minnesota
Edina, Minnesota, United States
Mississippi Baptist Medical Center
Jackson, Mississippi, United States
Pepose Vision Institute
Chesterfield, Missouri, United States
Retina Research Institute, LLC
St Louis, Missouri, United States
Sierra Eye Associates
Reno, Nevada, United States
The Retina Center Of New Jersey, LLC - Bloomfield
Bloomfield, New Jersey, United States
Long Island Vitreoretinal Consultants (VRC) - Hauppauge
Hauppauge, New York, United States
Retina-Vitreous Surgeons of Central New York
Liverpool, New York, United States
NY LIVRC Long Island Vitreoretinal Consultants
Shirley, New York, United States
Asheville Eye Associates (AEA) - Retinal Office
Asheville, North Carolina, United States
Duke University Health System - Duke Eye Center Of North Durham
Durham, North Carolina, United States
Retina Associates of Cleveland, Inc. - Beachwood
Beachwood, Ohio, United States
Retina Associates of Cleveland
Cleveland, Ohio, United States
Retina Associates of Cleveland, Inc. - Youngstown
Youngstown, Ohio, United States
Erie Retina Research
Erie, Pennsylvania, United States
Palmetto Retina Center
Aiken, South Carolina, United States
Charleston Neuroscience Institute LLC - Beaufort
Beaufort, South Carolina, United States
SC CNI Retina Consultants of Charleston
Beaufort, South Carolina, United States
Charleston Neuroscience Institute LLC - Charleston
Charleston, South Carolina, United States
Palmetto Retina Center
Florence, South Carolina, United States
Charleston Neuroscience Institute
Ladson, South Carolina, United States
Retina Consultants of Charleston - Mount Pleasant
Mt. Pleasant, South Carolina, United States
Palmetto Retina Center
West Columbia, South Carolina, United States
Black Hills Regional Eye Institute (BHREI)
Rapid City, South Dakota, United States
Vance Thompson Vision
Sioux Falls, South Dakota, United States
Charles Retina Institute PC
Germantown, Tennessee, United States
Tennessee Retina, PC - Nashville - Centennial Professional Plaza Location
Nashville, Tennessee, United States
West Texas Retina Consultants (WTRC) - Abilene (Ophthalmology Specialists of Texas, PA)
Abilene, Texas, United States
Texas Retina Associates (TRA) - Arlington
Arlington, Texas, United States
Retina Consultants of Austin PA (RCA) - Central Austin
Austin, Texas, United States
Austin Retina Associates, PLLC
Austin, Texas, United States
Keystone Research
Austin, Texas, United States
Retina Research Center (RRC)
Austin, Texas, United States
Retina Consultants of Texas Beaumont
Beaumont, Texas, United States
Retina Group, Inc. d/b/a Retina Consultants of America (Retina Consultants of Texas)
Bellaire, Texas, United States
Star Vision Consultants
Burleson, Texas, United States
Texas Retina Center
Houston, Texas, United States
Retina Consultants of Texas - Katy
Katy, Texas, United States
Medical Center Ophthalmology Associates (MCOA) - Northwest Clinic Location
San Antonio, Texas, United States
Retinal Consultants of Texas - San Antonio Medical Center
San Antonio, Texas, United States
TX RCTX Retina Consultants of Texas
San Antonio, Texas, United States
Retina Consultants of Houston
The Woodlands, Texas, United States
Retina Associates of Utah, P.C - Intermountain Medical Center Location
Salt Lake City, Utah, United States
Wagner Macula & Retina Center - Norfolk, VA Office
Norfolk, Virginia, United States
Vistar Eye Center Vision and Surgery Specialists
Roanoke, Virginia, United States
Eye Clinic of Wisconsin
Wausau, Wisconsin, United States
Buenos Aires Macula
Pilar, Buenos Aires, Argentina
Centro Oftalmologico Dr. Charles S.A
Buenos Aires, Buenos Aires F.D., Argentina
Organizacion Medica de Investigacion OMI
Buenos Aires, Buenos Aires F.D., Argentina
Fundacion Zambrano - Cirugia Ocular
Buenos Aires, Buenos Aires F.D., Argentina
Instituto Oftalmologico de Alta Complejidad
Buenos Aires, Buenos Aires F.D., Argentina
Oftalmologia Global
Rosario, Santa Fe Province, Argentina
Centro Privado de Ojos Romagosa SA
Córdoba, , Argentina
Oftar Mendoza Srl Centro Privado de Oftalmologia
Mendoza, , Argentina
Centrovision
Mendoza, , Argentina
Laser Vision Group
Santa Fe, , Argentina
Emanuelli research and development
Arecibo, , Puerto Rico
Countries
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Other Identifiers
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SOL-1
Identifier Type: OTHER
Identifier Source: secondary_id
OTX-TKI-2023-AMD-301
Identifier Type: -
Identifier Source: org_study_id
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