Study to Evaluate the Efficacy and Safety of Intravitreal OTX-TKI (Ocular Therapeutix) (Axitinib Implant) in Subjects With Neovascular Age-Related Macular Degeneration
- Conditions
- Neovascular Age-Related Macular Degeneration
- Interventions
- Drug: OTX-TKI (axitinib implant)
- Registration Number
- NCT06223958
- Lead Sponsor
- Ocular Therapeutix, Inc.
- Brief Summary
Study to Evaluate the Efficacy and Safety of Intravitreal OTX-TKI (axitinib implant) in Subjects with Neovascular Age-Related Macular Degeneration
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 344
- 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
- Monocular subjects or a Best Corrected Visual Acuity (BCVA) score of 20/200 in fellow eye at screening.
- Have evidence of a scar, fibrosis, or atrophy of > 50% of the total lesion in the study eye.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description OTX-TKI (axitinib implant) OTX-TKI (axitinib implant) - Control Aflibercept -
- Primary Outcome Measures
Name Time Method Best corrected visual acuity (BCVA) Up to 36 Weeks Maintenance of visual acuity, defined as \< 15 Early Treatment Diabetic Retinopathy Study (ETDRS) letters Best corrected visual acuity (BCVA) loss
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (105)
Retina Associates of Cleveland, Inc. - Beachwood
🇺🇸Beachwood, Ohio, United States
Associated Retina Consultants - Phoenix
🇺🇸Phoenix, Arizona, United States
CA CRC California Retina Consultants
🇺🇸Oxnard, California, United States
RSC Research, PLLC
🇺🇸Denver, Colorado, United States
The Macula Center - Clearwater Office (Suncoast Retina Consultants, LLC)
🇺🇸Clearwater, Florida, United States
SC CNI Retina Consultants of Charleston
🇺🇸Beaufort, South Carolina, United States
Associated Retina Consultants - Gilbert
🇺🇸Gilbert, Arizona, 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
Retinal Research Institute
🇺🇸Phoenix, Arizona, United States
Retina Macula Institute of Arizona
🇺🇸Scottsdale, Arizona, 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
Stanford University School of Medicine, Byers Eye Institute
🇺🇸Palo Alto, California, United States
Doheny Eye Center
🇺🇸Pasadena, California, United States
Macula Retina Vitreous Center
🇺🇸Torrance, California, United States
Speciality Retina Center
🇺🇸Deerfield Beach, Florida, United States
Retina Consultants of Southern Colorado - Colorado Springs
🇺🇸Colorado Springs, Colorado, United States
Colorado Retina Associates (CRA) - Lakewood
🇺🇸Lakewood, Colorado, United States
Rand Eye Institute
🇺🇸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
Bay Area Retina Associates, A Medical Group
🇺🇸Walnut Creek, California, United States
Retina Group of New England, PC
🇺🇸Waterford, Connecticut, United States
Retina Associates of Florida LLC Tampa MacDill
🇺🇸Tampa, Florida, United States
Florida Retina Consultants - Lakeland
🇺🇸Lakeland, Florida, United States
Southeast Retina Center, P.C. - Augusta
🇺🇸Augusta, Georgia, United States
Cumberland Valley Retina Consultants
🇺🇸Hagerstown, Maryland, United States
Associated Retinal Consultants P.C. (ARC) - Royal Oak
🇺🇸Royal Oak, Michigan, United States
Retina Consultants of Minnesota
🇺🇸Edina, Minnesota, United States
Retina Research Institute, LLC
🇺🇸Saint Louis, Missouri, United States
Asheville Eye Associates (AEA) - Retinal Office
🇺🇸Asheville, North Carolina, United States
Retina Associates of Cleveland, Inc. - Youngstown
🇺🇸Youngstown, Ohio, United States
Charleston Neuroscience Institute LLC - Beaufort
🇺🇸Beaufort, South Carolina, United States
Retina Research Center (RRC)
🇺🇸Austin, Texas, United States
Star Vision Consultants
🇺🇸Burleson, Texas, United States
South Florida Retina Institute
🇺🇸Miami, Florida, United States
Retina Specialty Institute - Pensacola
🇺🇸Pensacola, Florida, United States
Illinois Eye and Ear Infirmary at UI Health UIC
🇺🇸Chicago, Illinois, United States
University Retina and Macula Associates, P.C.
🇺🇸Oak Forest, Illinois, United States
Retina Vitreous Associates of Florida (RVA) - Saint Petersburg
🇺🇸Saint Petersburg, Florida, United States
MedEye Associates - Miami
🇺🇸South Miami, Florida, United States
Retina Vitreous Associates of Florida - Tampa
🇺🇸Tampa, Florida, United States
Illinois Retina Associates, S.C. - Lincoln Park
🇺🇸Chicago, Illinois, United States
Springfield Clinic
🇺🇸Springfield, Illinois, United States
IN AVRUC Associated Vitreoretinal and Uveitis Consultants
🇺🇸Carmel, Indiana, United States
Wolfe Eye Clinic
🇺🇸West Des Moines, Iowa, United States
Maine Eye Center - Marginal Way Campus
🇺🇸Portland, Maine, United States
Mid Atlantic Retina Specialists - Hagerstown
🇺🇸Hagerstown, Maryland, United States
Retina Consultants of Austin PA (RCA) - Central Austin
🇺🇸Austin, Texas, United States
The Retina Center Of New Jersey, LLC - Bloomfield
🇺🇸Bloomfield, New Jersey, United States
Retina-Vitreous Surgeons of Central New York
🇺🇸Liverpool, New York, United States
Retina Associates of Cleveland
🇺🇸Cleveland, Ohio, United States
Charleston Neuroscience Institute LLC - Charleston
🇺🇸Charleston, South Carolina, United States
Charles Retina Institute PC
🇺🇸Germantown, Tennessee, United States
Texas Retina Associates (TRA) - Arlington
🇺🇸Arlington, Texas, United States
Retina Group, Inc. d/b/a Retina Consultants of America (Retina Consultants of Texas)
🇺🇸Bellaire, Texas, United States
Mississippi Baptist Medical Center
🇺🇸Jackson, Mississippi, United States
Pepose Vision Institute
🇺🇸Chesterfield, Missouri, United States
Erie Retina Research
🇺🇸Erie, Pennsylvania, United States
Vance Thompson Vision
🇺🇸Sioux Falls, South Dakota, 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
Austin Retina Associates, PLLC
🇺🇸Austin, Texas, United States
Retina Consultants of Texas Beaumont
🇺🇸Beaumont, Texas, United States
Texas Retina Center
🇺🇸Houston, Texas, United States
Retina Partners Midwest
🇺🇸Indianapolis, Indiana, United States
The Wilmer Eye Institute
🇺🇸Baltimore, Maryland, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
Sierra Eye Associates
🇺🇸Reno, Nevada, United States
Long Island Vitreoretinal Consultants (VRC) - Hauppauge
🇺🇸Hauppauge, New York, United States
NY LIVRC Long Island Vitreoretinal Consultants
🇺🇸Shirley, New York, 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
Duke University Health System - Duke Eye Center Of North Durham
🇺🇸Durham, North Carolina, United States
Palmetto Retina Center
🇺🇸West Columbia, South Carolina, United States
Charleston Neuroscience Institute
🇺🇸Ladson, South Carolina, United States
Retina Consultants of Charleston - Mount Pleasant
🇺🇸Mount Pleasant, South Carolina, United States
Black Hills Regional Eye Institute (BHREI)
🇺🇸Rapid City, South Dakota, United States
Keystone Research
🇺🇸Austin, 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
TX RCTX Retina Consultants of Texas
🇺🇸San Antonio, Texas, United States
Retinal Consultants of Texas - San Antonio Medical Center
🇺🇸San Antonio, Texas, 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, Caba, Argentina
Organizacion Medica de Investigacion OMI
🇦🇷Buenos Aires, Caba, Argentina
Fundacion Zambrano - Cirugia Ocular
🇦🇷Buenos Aires, Caba, Argentina
Instituto Oftalmologico de Alta Complejidad
🇦🇷Buenos Aires, Caba, Argentina
Oftalmologia Global
🇦🇷Rosario, Santa Fe, Argentina
Centro Privado de Ojos Romagosa SA
🇦🇷Cordoba, 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