Study to Evaluate the Efficacy and Safety of Intravitreal OTX-TKI (Axitinib Implant) in Subjects With Neovascular Age- Related Macular Degeneration
- Conditions
- Neovascular Age-related Macular Degeneration
- Interventions
- Registration Number
- NCT06495918
- 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
- RECRUITING
- Sex
- All
- Target Recruitment
- 825
- Treatment naïve juxtafoveal and/or SFNV secondary to Neovascular Age- Related Macular Degeneration (nAMD) with leakage involving the fovea in the study eye prior to Screening, or have a diagnosis of Neovascular Age- Related Macular Degeneration (nAMD) in study eye within 3 months prior to screening and received up to 2 monthly injections of 2 mg aflibercept with last injection approximately 4 weeks prior to Screening
- Have provided written consent
- Monocular subject or Best Corrected Visual Acuity (BCVA) score of <20 ETDRS letters or 20/400 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 Re-dose OTX-TKI - Aflibercept 2mg on label Aflibercept - Aflibercept 8mg high dose Aflibercept -
- Primary Outcome Measures
Name Time Method Best Corrected Visual Acuity (BCVA) Week 48 Mean change in Best Corrected Visual Acuity (BCVA) from baseline at Week 48
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (86)
Associated Retina Consultant
🇺🇸Gilbert, Arizona, United States
Associated Retina Consultants, Ltd.
🇺🇸Phoenix, Arizona, United States
Retinal Research Institute, LLC
🇺🇸Phoenix, Arizona, United States
Retina Macula Institute of Arizona
🇺🇸Scottsdale, Arizona, United States
California Retina Consultants
🇺🇸Santa Barbara, California, United States
The Retina Partners
🇺🇸Encino, California, United States
Retina Consultants of Orange County
🇺🇸Fullerton, California, United States
Atlantis Eyecare
🇺🇸Huntington Beach, California, United States
Salehi Retina Institute, Inc., dba Retina Associates of Southern California
🇺🇸Huntington Beach, 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
California Eye Specialists Medical Group, INC
🇺🇸Pasadena, California, United States
Retinal Consultants Medical Group
🇺🇸Sacramento, California, United States
Orange County Retina Medical Group
🇺🇸Santa Ana, California, United States
Macula Retina Vitreous Research Institute
🇺🇸Torrance, California, United States
Bay Area Retina Associates
🇺🇸Walnut Creek, California, United States
Retina Consultants of Southern Colorado
🇺🇸Colorado Springs, Colorado, United States
RSC Research, LLC
🇺🇸Denver, Colorado, United States
Colorado Retina Associates
🇺🇸Lakewood, Colorado, United States
Retina Consultants, P.C
🇺🇸Manchester, Connecticut, United States
Retina Group of New England
🇺🇸Waterford, Connecticut, United States
Advanced Research LLC.
🇺🇸Deerfield Beach, Florida, United States
Rand Eye Institute
🇺🇸Deerfield Beach, Florida, United States
Retina Group of Florida
🇺🇸Fort Lauderdale, Florida, United States
Florida Retina Consultants
🇺🇸Lakeland, Florida, United States
South Florida Retina Institute
🇺🇸Miami, Florida, United States
Florida Retina Institude
🇺🇸Orlando, Florida, United States
Retina Specialty Institute
🇺🇸Pensacola, Florida, United States
Retina Vitreous Associates of Florida- Saint Petersburg
🇺🇸Saint Petersburg, Florida, United States
MedEye Associates
🇺🇸South Miami, Florida, United States
Retina Vitreous Associates of Florida
🇺🇸Tampa, Florida, United States
Southeast Retina Center
🇺🇸Augusta, Georgia, United States
University Retina and Macula Associates, PC
🇺🇸Oak Forest, Illinois, United States
Illinois Retina Associates
🇺🇸Oak Park, Illinois, United States
Springfield Clinic Opthalmology Department
🇺🇸Springfield, Illinois, United States
Associate Vitreoretinal and Uveitis Consultants
🇺🇸Carmel, Indiana, United States
Retina Partners Midwest, P.C.
🇺🇸Carmel, Indiana, United States
Wolfe Clinic PC dba Wolfe Eye Clinic
🇺🇸West Des Moines, Iowa, United States
The Retina Group of Washington - Chevy Chase
🇺🇸Chevy Chase, Maryland, United States
Cumberland Valley Retina Consultants
🇺🇸Hagerstown, Maryland, United States
Mid Atlantic Retina Specialists
🇺🇸Hagerstown, Maryland, United States
Retina Specialists - Towson Office
🇺🇸Towson, Maryland, United States
Associated Retinal Consultants, P.C.
🇺🇸Royal Oak, Michigan, United States
Retina Consultants of Minnesota
🇺🇸Minneapolis, Minnesota, United States
Mississippi Retina Associates
🇺🇸Madison, Mississippi, United States
The Retina Institute
🇺🇸Saint Louis, Missouri, United States
Sierra Eye Associates
🇺🇸Reno, Nevada, United States
Envision Ocular, LLC
🇺🇸Bloomfield, New Jersey, United States
Vision Research Center Eye Associates of New Mexico
🇺🇸Albuquerque, New Mexico, United States
Retina Vitreous Surgeons of CNY, PC
🇺🇸Liverpool, New York, United States
Asheville Eye Associates (AEA) - Asheville
🇺🇸Asheville, North Carolina, United States
Cincinnati Eye Institute
🇺🇸Cincinnati, Ohio, United States
EyeHealth Northwest
🇺🇸Portland, Oregon, United States
Erie Retina Research
🇺🇸Erie, Pennsylvania, United States
Palmetto Retina Center, LLC
🇺🇸West Columbia, South Carolina, United States
Charleston Neuroscience Instititute, LLC
🇺🇸Beaufort, South Carolina, United States
Black Hills Regional Eye Institute, LLP
🇺🇸Rapid City, South Dakota, United States
Charles Retina Institute
🇺🇸Germantown, Tennessee, United States
Southeastern Retina Associates PC
🇺🇸Johnson City, Tennessee, United States
Tennessee Retina, PC
🇺🇸Nashville, Tennessee, United States
Retina Research Institute of Texas
🇺🇸Abilene, Texas, United States
Texas Retina Associates
🇺🇸Dallas, Texas, United States
Austin Research Center for Retina
🇺🇸Austin, Texas, United States
Austin Retina Associates
🇺🇸Austin, Texas, United States
Retina Consultants of Texas
🇺🇸The Woodlands, Texas, United States
Star Vision Research
🇺🇸Burleson, Texas, United States
Texas Retina Center
🇺🇸Houston, Texas, United States
Retina Center of Texas
🇺🇸Southlake, Texas, United States
Retina Associates of Utah
🇺🇸Salt Lake City, Utah, United States
Rocky Mountain Retina Consultants
🇺🇸Salt Lake City, Utah, United States
Retina Group of Washington
🇺🇸Fairfax, Virginia, United States
Vistar Eye Center
🇺🇸Roanoke, Virginia, United States
Eye Clinic of Wisconsin, SC
🇺🇸Wausau, Wisconsin, United States
Organización Médica de Investigación (OMI)
🇦🇷Buenos Aires, Argentina
Centro Privado de Ojos
🇦🇷Buenos Aires, Argentina
Buenos Aires Macula
🇦🇷Caba, Argentina
Instituto Oftalmologico de Buenos Aires SA - OFTALMOS
🇦🇷Caba, Argentina
Fundacion Zambrano - Cirugia Ocular
🇦🇷Caba, Argentina
Charles Research Center (Centro Oftalmologico Dr. Charles S.A)
🇦🇷Ciudad Autonoma de Buenos Aires, Argentina
Fundacion Jorge Zambrano para la investigacion, Diagnostico y Tratamiento de las enfermedades oculares
🇦🇷Ciudad Autonoma de Buenos Aire, Argentina
Centro Vision S.A.
🇦🇷Ciudad de Mendoza, Argentina
Oftar Mendoza Srl Centro Privado de Oftalmologia
🇦🇷Mendoza, Argentina
Laser Vision Group
🇦🇷Rosario, Argentina
Albury Eye Clinic
🇦🇺Albury, New South Wales, Australia
Marsden Eye Specialists (MES) - Parramatta
🇦🇺Parramatta, New South Wales, Australia
Emanuelli Research and Development Center, LLC
🇵🇷Arecibo, Puerto Rico