NCT06495918Active, not recruitingPhase 3
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
Source: ClinicalTrials.gov · Last updated 17 Jun 2025
Brief summary (registry, in English)
Study to Evaluate the Efficacy and Safety of Intravitreal OTX-TKI (Axitinib Implant) in Subjects with Neovascular Age- Related Macular Degeneration
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 825 (estimated)
- First submitted
- 3 Jul 2024
- Start date
- 27 Nov 2024
- Primary completion date
- 8 Jan 2027
- Lead sponsor
- Ocular Therapeutix, Inc.
- Diseases
- Macular degeneration
- NCT number
- NCT06495918
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 825
- From 27 Nov 2024 to the primary completion date, 8 Jan 2027
- 97 sites in 4 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- 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.
Who the study is looking for
- 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
Age in the registry: 50 years to - · Sex: All · Does not accept healthy volunteers
Sites (97)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Charles Research Center (Centro Oftalmologico Dr. Charles S.A) Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| Centro Privado de Ojos Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| Organización Médica de Investigación (OMI) Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| Fundacion Zambrano - Cirugia Ocular Coordinator of this site? Confirm its status | Caba | Argentina | Unknown status |
| Buenos Aires Macula Coordinator of this site? Confirm its status | Caba | Argentina | Unknown status |
| Instituto Oftalmologico de Buenos Aires SA - OFTALMOS Coordinator of this site? Confirm its status | Caba | Argentina | Unknown status |
| Fundacion Jorge Zambrano para la investigacion, Diagnostico y Tratamiento de las enfermedades oculares Coordinator of this site? Confirm its status | Ciudad Autonoma de Buenos Aire | Argentina | Unknown status |
| Oftar Mendoza Srl Centro Privado de Oftalmologia Coordinator of this site? Confirm its status | Mendoza | Argentina | Unknown status |
| Centro Vision S.A. Coordinator of this site? Confirm its status | Mendoza | Argentina | Unknown status |
| Laser Vision Group Coordinator of this site? Confirm its status | Rosario | Argentina | Unknown status |
| Albury Eye Clinic Coordinator of this site? Confirm its status | Albury | Australia | Unknown status |
| Marsden Eye Specialists (MES) - Parramatta Coordinator of this site? Confirm its status | Parramatta | Australia | Unknown status |
| Emanuelli Research and Development Center, LLC Coordinator of this site? Confirm its status | Arecibo | Puerto Rico | Unknown status |
| Retina Research Institute of Texas Coordinator of this site? Confirm its status | Abilene | United States | Unknown status |
| Palmetto Retina Center, LLC Coordinator of this site? Confirm its status | Aiken | United States | Unknown status |
| Vision Research Center Eye Associates of New Mexico Coordinator of this site? Confirm its status | Albuquerque | United States | Unknown status |
| Texas Retina Associates Coordinator of this site? Confirm its status | Arlington | United States | Unknown status |
| Asheville Eye Associates (AEA) - Asheville Coordinator of this site? Confirm its status | Asheville | United States | Unknown status |
| Southeast Retina Center Coordinator of this site? Confirm its status | Augusta | United States | Unknown status |
| Austin Retina Associates Coordinator of this site? Confirm its status | Austin | United States | Unknown status |
| Austin Research Center for Retina Coordinator of this site? Confirm its status | Austin | United States | Unknown status |
| California Retina Consultants Coordinator of this site? Confirm its status | Bakersfield | United States | Unknown status |
| Charleston Neuroscience Instititute, LLC Coordinator of this site? Confirm its status | Beaufort | United States | Unknown status |
| Retina Consultants of Texas Coordinator of this site? Confirm its status | Beaumont | United States | Unknown status |
| Retina Consultants of Texas Coordinator of this site? Confirm its status | Bellaire | United States | Unknown status |
| Envision Ocular, LLC Coordinator of this site? Confirm its status | Bloomfield | United States | Unknown status |
| Star Vision Research Coordinator of this site? Confirm its status | Burleson | United States | Unknown status |
| Retina Partners Midwest, P.C. Coordinator of this site? Confirm its status | Carmel | United States | Unknown status |
| Associate Vitreoretinal and Uveitis Consultants Coordinator of this site? Confirm its status | Carmel | United States | Unknown status |
| The Retina Group of Washington - Chevy Chase Coordinator of this site? Confirm its status | Chevy Chase | United States | Unknown status |
| Cincinnati Eye Institute Coordinator of this site? Confirm its status | Cincinnati | United States | Unknown status |
| Retina Consultants of Southern Colorado Coordinator of this site? Confirm its status | Colorado Springs | United States | Unknown status |
| Texas Retina Associates Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| Advanced Research LLC Coordinator of this site? Confirm its status | Deerfield Beach | United States | Unknown status |
| Rand Eye Institute Coordinator of this site? Confirm its status | Deerfield Beach | United States | Unknown status |
| RSC Research, LLC Coordinator of this site? Confirm its status | Denver | United States | Unknown status |
| The Retina Partners Coordinator of this site? Confirm its status | Encino | United States | Unknown status |
| Erie Retina Research Coordinator of this site? Confirm its status | Erie | United States | Unknown status |
| Retina Group of Washington Coordinator of this site? Confirm its status | Fairfax | United States | Unknown status |
| Palmetto Retina Center, LLC Coordinator of this site? Confirm its status | Florence | United States | Unknown status |
| Retina Group of Florida Coordinator of this site? Confirm its status | Fort Lauderdale | United States | Unknown status |
| Retina Consultants of Orange County Coordinator of this site? Confirm its status | Fullerton | United States | Unknown status |
| Charles Retina Institute Coordinator of this site? Confirm its status | Germantown | United States | Unknown status |
| Associated Retina Consultant Coordinator of this site? Confirm its status | Gilbert | United States | Unknown status |
| Mid Atlantic Retina Specialists Coordinator of this site? Confirm its status | Hagerstown | United States | Unknown status |
| Cumberland Valley Retina Consultants Coordinator of this site? Confirm its status | Hagerstown | United States | Unknown status |
| Texas Retina Center Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Atlantis Eyecare Coordinator of this site? Confirm its status | Huntington Beach | United States | Unknown status |
| Salehi Retina Institute, Inc., dba Retina Associates of Southern California Coordinator of this site? Confirm its status | Huntington Beach | United States | Unknown status |
| Retina Partners Midwest Coordinator of this site? Confirm its status | Indianapolis | United States | Unknown status |
| Southeastern Retina Associates PC Coordinator of this site? Confirm its status | Johnson City | United States | Unknown status |
| Retina Consultants of Texas Coordinator of this site? Confirm its status | Katy | United States | Unknown status |
| Florida Retina Consultants Coordinator of this site? Confirm its status | Lakeland | United States | Unknown status |
| Colorado Retina Associates Coordinator of this site? Confirm its status | Lakewood | United States | Unknown status |
| Retina Vitreous Surgeons of CNY, PC Coordinator of this site? Confirm its status | Liverpool | United States | Unknown status |
| Mississippi Retina Associates Coordinator of this site? Confirm its status | Madison | United States | Unknown status |
| Retina Consultants, P.C Coordinator of this site? Confirm its status | Manchester | United States | Unknown status |
| South Florida Retina Institute Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| Retina Consultants of Minnesota Coordinator of this site? Confirm its status | Minneapolis | United States | Unknown status |
| Tennessee Retina, PC Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| University Retina and Macula Associates, PC Coordinator of this site? Confirm its status | Oak Forest | United States | Unknown status |
| Kaiser Permanente Division of Research Coordinator of this site? Confirm its status | Oakland | United States | Unknown status |
| Illinois Retina Associates Coordinator of this site? Confirm its status | Oak Park | United States | Unknown status |
| Florida Retina Institude Coordinator of this site? Confirm its status | Orlando | United States | Unknown status |
| California Retina Consultants Coordinator of this site? Confirm its status | Oxnard | United States | Unknown status |
| Stanford Health Care - Byers Eye Institute Coordinator of this site? Confirm its status | Palo Alto | United States | Unknown status |
| Stanford University School of Medicine, Byers Eye Institute Coordinator of this site? Confirm its status | Palo Alto | United States | Unknown status |
| California Eye Specialists Medical Group, Inc. Coordinator of this site? Confirm its status | Pasadena | United States | Unknown status |
| Retina Specialty Institute Coordinator of this site? Confirm its status | Pensacola | United States | Unknown status |
| Associated Retina Consultants, Ltd. Coordinator of this site? Confirm its status | Phoenix | United States | Unknown status |
| Retinal Research Institute, LLC Coordinator of this site? Confirm its status | Phoenix | United States | Unknown status |
| EyeHealth Northwest Coordinator of this site? Confirm its status | Portland | United States | Unknown status |
| Black Hills Regional Eye Institute, LLP Coordinator of this site? Confirm its status | Rapid City | United States | Unknown status |
| Sierra Eye Associates Coordinator of this site? Confirm its status | Reno | United States | Unknown status |
| Vistar Eye Center Coordinator of this site? Confirm its status | Roanoke | United States | Unknown status |
| Associated Retinal Consultants, P.C. Coordinator of this site? Confirm its status | Royal Oak | United States | Unknown status |
| Retinal Consultants Medical Group Coordinator of this site? Confirm its status | Sacramento | United States | Unknown status |
| Retina Associates of Utah Coordinator of this site? Confirm its status | Salt Lake City | United States | Unknown status |
| Rocky Mountain Retina Consultants Coordinator of this site? Confirm its status | Salt Lake City | United States | Unknown status |
| Retina Consultants of Texas Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
| Orange County Retina Medical Group Coordinator of this site? Confirm its status | Santa Ana | United States | Unknown status |
| California Retina Consultants Coordinator of this site? Confirm its status | Santa Barbara | United States | Unknown status |
| Retina Macula Institute of Arizona Coordinator of this site? Confirm its status | Scottsdale | United States | Unknown status |
| Retina Center of Texas Coordinator of this site? Confirm its status | Southlake | United States | Unknown status |
| MedEye Associates Coordinator of this site? Confirm its status | South Miami | United States | Unknown status |
| Springfield Clinic Opthalmology Department Coordinator of this site? Confirm its status | Springfield | United States | Unknown status |
| The Retina Institute Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
| Retina Vitreous Associates of Florida - Saint Petersburg Coordinator of this site? Confirm its status | St. Petersburg | United States | Unknown status |
| Retina Vitreous Associates of Florida Coordinator of this site? Confirm its status | Tampa | United States | Unknown status |
| Retina Consultants of Texas Coordinator of this site? Confirm its status | The Woodlands | United States | Unknown status |
| Macula Retina Vitreous Research Institute Coordinator of this site? Confirm its status | Torrance | United States | Unknown status |
| Retina Specialists - Towson Office Coordinator of this site? Confirm its status | Towson | United States | Unknown status |
| Bay Area Retina Associates Coordinator of this site? Confirm its status | Walnut Creek | United States | Unknown status |
| Retina Group of New England Coordinator of this site? Confirm its status | Waterford | United States | Unknown status |
| Eye Clinic of Wisconsin, SC Coordinator of this site? Confirm its status | Wausau | United States | Unknown status |
| Palmetto Retina Center, LLC Coordinator of this site? Confirm its status | West Columbia | United States | Unknown status |
| Wolfe Clinic PC dba Wolfe Eye Clinic Coordinator of this site? Confirm its status | West Des Moines | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.