Study to Evaluate the Efficacy and Safety of Intravitreal OTX-TKI (Axitinib Implant) in Subjects With Neovascular Age- Related Macular Degeneration
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
1 other identifier
interventional
825
4 countries
97
Brief Summary
Study to Evaluate the Efficacy and Safety of Intravitreal OTX-TKI (Axitinib Implant) in Subjects with Neovascular Age- Related Macular Degeneration
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Nov 2024
97 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 3, 2024
CompletedFirst Posted
Study publicly available on registry
July 11, 2024
CompletedStudy Start
First participant enrolled
November 27, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 8, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 8, 2027
June 17, 2025
June 1, 2025
2.1 years
July 3, 2024
June 16, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Best Corrected Visual Acuity (BCVA)
Mean change in Best Corrected Visual Acuity (BCVA) from baseline at Week 48
Week 48
Study Arms (3)
OTX-TKI Re-dose
EXPERIMENTALAflibercept 2mg on label
ACTIVE COMPARATORAflibercept 8mg high dose
OTHERInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ocular Therapeutix, Inc.lead
- Fortreacollaborator
- Duke Universitycollaborator
Study Sites (97)
Associated Retina Consultant
Gilbert, Arizona, 85297, United States
Associated Retina Consultants, Ltd.
Phoenix, Arizona, 85020, United States
Retinal Research Institute, LLC
Phoenix, Arizona, 85053, United States
Retina Macula Institute of Arizona
Scottsdale, Arizona, 85255, United States
California Retina Consultants
Bakersfield, California, 93309, United States
The Retina Partners
Encino, California, 91436, United States
Retina Consultants of Orange County
Fullerton, California, 92835, United States
Atlantis Eyecare
Huntington Beach, California, 92647, United States
Salehi Retina Institute, Inc., dba Retina Associates of Southern California
Huntington Beach, California, 92647, United States
Kaiser Permanente Division of Research
Oakland, California, 94611, United States
California Retina Consultants
Oxnard, California, 93036, United States
Stanford Health Care - Byers Eye Institute
Palo Alto, California, 94303, United States
Stanford University School of Medicine, Byers Eye Institute
Palo Alto, California, 94303, United States
California Eye Specialists Medical Group, INC
Pasadena, California, 91107, United States
Retinal Consultants Medical Group
Sacramento, California, 95841, United States
Orange County Retina Medical Group
Santa Ana, California, 92705, United States
California Retina Consultants
Santa Barbara, California, 93103, United States
Macula Retina Vitreous Research Institute
Torrance, California, 90503, United States
Bay Area Retina Associates
Walnut Creek, California, 94598, United States
Retina Consultants of Southern Colorado
Colorado Springs, Colorado, 80909, United States
RSC Research, LLC
Denver, Colorado, 80210, United States
Colorado Retina Associates
Lakewood, Colorado, 80228, United States
Retina Consultants, P.C
Manchester, Connecticut, 06042, United States
Retina Group of New England
Waterford, Connecticut, 06385, United States
Advanced Research LLC.
Deerfield Beach, Florida, 33064, United States
Rand Eye Institute
Deerfield Beach, Florida, 33064, United States
Retina Group of Florida
Fort Lauderdale, Florida, 33308, United States
Florida Retina Consultants
Lakeland, Florida, 33805, United States
South Florida Retina Institute
Miami, Florida, 33145, United States
Florida Retina Institude
Orlando, Florida, 32806, United States
Retina Specialty Institute
Pensacola, Florida, 32503, United States
MedEye Associates
South Miami, Florida, 33143, United States
Retina Vitreous Associates of Florida- Saint Petersburg
St. Petersburg, Florida, 33711, United States
Retina Vitreous Associates of Florida
Tampa, Florida, 33617, United States
Southeast Retina Center
Augusta, Georgia, 30909, United States
University Retina and Macula Associates, PC
Oak Forest, Illinois, 60452, United States
Illinois Retina Associates
Oak Park, Illinois, 60304, United States
Springfield Clinic Opthalmology Department
Springfield, Illinois, 62703, United States
Associate Vitreoretinal and Uveitis Consultants
Carmel, Indiana, 46032, United States
Retina Partners Midwest, P.C.
Carmel, Indiana, 46290, United States
Retina Partners Midwest
Indianapolis, Indiana, 46290, United States
Wolfe Clinic PC dba Wolfe Eye Clinic
West Des Moines, Iowa, 50026, United States
The Retina Group of Washington - Chevy Chase
Chevy Chase, Maryland, 20815, United States
Cumberland Valley Retina Consultants
Hagerstown, Maryland, 21740, United States
Mid Atlantic Retina Specialists
Hagerstown, Maryland, 21740, United States
Retina Specialists - Towson Office
Towson, Maryland, 21204, United States
Associated Retinal Consultants, P.C.
Royal Oak, Michigan, 48073, United States
Retina Consultants of Minnesota
Minneapolis, Minnesota, 55435, United States
Mississippi Retina Associates
Madison, Mississippi, 39110, United States
The Retina Institute
St Louis, Missouri, 63128, United States
Sierra Eye Associates
Reno, Nevada, 89502, United States
Envision Ocular, LLC
Bloomfield, New Jersey, 07003, United States
Vision Research Center Eye Associates of New Mexico
Albuquerque, New Mexico, 87109, United States
Retina Vitreous Surgeons of CNY, PC
Liverpool, New York, 13088, United States
Asheville Eye Associates (AEA) - Asheville
Asheville, North Carolina, 28803, United States
Cincinnati Eye Institute
Cincinnati, Ohio, 45242, United States
EyeHealth Northwest
Portland, Oregon, 97225, United States
Erie Retina Research
Erie, Pennsylvania, 16507, United States
Palmetto Retina Center, LLC
Aiken, South Carolina, 29802, United States
Charleston Neuroscience Instititute, LLC
Beaufort, South Carolina, 29902, United States
Palmetto Retina Center, LLC
Florence, South Carolina, 29501, United States
Palmetto Retina Center, LLC
West Columbia, South Carolina, 29169, United States
Black Hills Regional Eye Institute, LLP
Rapid City, South Dakota, 57701, United States
Charles Retina Institute
Germantown, Tennessee, 38138, United States
Southeastern Retina Associates PC
Johnson City, Tennessee, 37604, United States
Tennessee Retina, PC
Nashville, Tennessee, 37203, United States
Retina Research Institute of Texas
Abilene, Texas, 79606, United States
Texas Retina Associates
Arlington, Texas, 76012, United States
Austin Research Center for Retina
Austin, Texas, 78705, United States
Austin Retina Associates
Austin, Texas, 78705, United States
Retina Consultants of Texas
Beaumont, Texas, 77707, United States
Retina Consultants of Texas
Bellaire, Texas, 77401, United States
Star Vision Research
Burleson, Texas, 76028, United States
Texas Retina Associates
Dallas, Texas, 75231, United States
Texas Retina Center
Houston, Texas, 77030, United States
Retina Consultants of Texas
Katy, Texas, 77494, United States
Retina Consultants of Texas
San Antonio, Texas, 78240, United States
Retina Center of Texas
Southlake, Texas, 76092, United States
Retina Consultants of Texas
The Woodlands, Texas, 77384, United States
Retina Associates of Utah
Salt Lake City, Utah, 84107, United States
Rocky Mountain Retina Consultants
Salt Lake City, Utah, 84107, United States
Retina Group of Washington
Fairfax, Virginia, 22031, United States
Vistar Eye Center
Roanoke, Virginia, 24019, United States
Eye Clinic of Wisconsin, SC
Wausau, Wisconsin, 54403, United States
Organización Médica de Investigación (OMI)
Buenos Aires, 1015, Argentina
Centro Privado de Ojos
Buenos Aires, C1033AAW, Argentina
Charles Research Center (Centro Oftalmologico Dr. Charles S.A)
Buenos Aires, C1121ABB, Argentina
Buenos Aires Macula
Caba, C1061AAE, Argentina
Instituto Oftalmologico de Buenos Aires SA - OFTALMOS
Caba, C1120AAN, Argentina
Fundacion Zambrano - Cirugia Ocular
Caba, S, Argentina
Fundacion Jorge Zambrano para la investigacion, Diagnostico y Tratamiento de las enfermedades oculares
Ciudad Autonoma de Buenos Aire, C1023AAQ, Argentina
Oftar Mendoza Srl Centro Privado de Oftalmologia
Mendoza, M5500GGK, Argentina
Centro Vision S.A.
Mendoza, M5500, Argentina
Laser Vision Group
Rosario, S2000, Argentina
Albury Eye Clinic
Albury, New South Wales, 2640, Australia
Marsden Eye Specialists (MES) - Parramatta
Parramatta, New South Wales, 2150, Australia
Emanuelli Research and Development Center, LLC
Arecibo, 612, Puerto Rico
MeSH Terms
Interventions
Study Officials
- PRINCIPAL INVESTIGATOR
Dilsher Dhoot, MD
California Retina Consultants (CRC) - Santa Barbara
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 3, 2024
First Posted
July 11, 2024
Study Start
November 27, 2024
Primary Completion (Estimated)
January 8, 2027
Study Completion (Estimated)
January 8, 2027
Last Updated
June 17, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will not share