NCT06223958Active, not recruitingPhase 3
Study to Evaluate the Efficacy and Safety of Intravitreal OTX-TKI (Ocular Therapeutix) (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 (nAMD)
Source: ClinicalTrials.gov · Last updated 18 Apr 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
- 344 (actual)
- First submitted
- 12 Jan 2024
- Start date
- 29 Jan 2024
- Primary completion date
- 29 Apr 2026
- Lead sponsor
- Ocular Therapeutix, Inc.
- Diseases
- Macular degeneration
- NCT number
- NCT06223958
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 344
- From 29 Jan 2024 to the primary completion date, 29 Apr 2026
- 108 sites in 3 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 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.
Who the study is looking for
- 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
Age in the registry: 50 years to - · Sex: All · Does not accept healthy volunteers
Sites (108)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fundacion Zambrano - Cirugia Ocular 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 |
| Instituto Oftalmologico de Alta Complejidad Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| Centro Oftalmologico Dr. Charles S.A Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| Centro Privado de Ojos Romagosa SA Coordinator of this site? Confirm its status | Córdoba | Argentina | Unknown status |
| Oftar Mendoza Srl Centro Privado de Oftalmologia Coordinator of this site? Confirm its status | Mendoza | Argentina | Unknown status |
| Centrovisión Coordinator of this site? Confirm its status | Mendoza | Argentina | Unknown status |
| Buenos Aires Macula Coordinator of this site? Confirm its status | Pilar | Argentina | Unknown status |
| Oftalmologia Global Coordinator of this site? Confirm its status | Rosario | Argentina | Unknown status |
| Laser Vision Group Coordinator of this site? Confirm its status | Santa Fe | Argentina | Unknown status |
| Emanuelli research and development Coordinator of this site? Confirm its status | Arecibo | Puerto Rico | Unknown status |
| West Texas Retina Consultants (WTRC) - Abilene (Ophthalmology Specialists of Texas, PA) Coordinator of this site? Confirm its status | Abilene | United States | Unknown status |
| Palmetto Retina Center Coordinator of this site? Confirm its status | Aiken | United States | Unknown status |
| Texas Retina Associates (TRA) - Arlington Coordinator of this site? Confirm its status | Arlington | United States | Unknown status |
| Asheville Eye Associates (AEA) - Retinal Office Coordinator of this site? Confirm its status | Asheville | United States | Unknown status |
| Southeast Retina Center, P.C. - Augusta Coordinator of this site? Confirm its status | Augusta | United States | Unknown status |
| Austin Retina Associates, PLLC Coordinator of this site? Confirm its status | Austin | United States | Unknown status |
| Retina Research Center (RRC) Coordinator of this site? Confirm its status | Austin | United States | Unknown status |
| Retina Consultants of Austin PA (RCA) - Central Austin Coordinator of this site? Confirm its status | Austin | United States | Unknown status |
| Keystone Research Coordinator of this site? Confirm its status | Austin | United States | Unknown status |
| CA CRC California Retina Consultants Coordinator of this site? Confirm its status | Bakersfield | United States | Unknown status |
| The Wilmer Eye Institute Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
| Retina Associates of Cleveland, Inc. - Beachwood Coordinator of this site? Confirm its status | Beachwood | United States | Unknown status |
| Charleston Neuroscience Institute LLC - Beaufort Coordinator of this site? Confirm its status | Beaufort | United States | Unknown status |
| SC CNI Retina Consultants of Charleston Coordinator of this site? Confirm its status | Beaufort | United States | Unknown status |
| Retina Consultants of Texas - Beaumont Coordinator of this site? Confirm its status | Beaumont | United States | Unknown status |
| Retina Group, Inc. d/b/a Retina Consultants of America (Retina Consultants of Texas) Coordinator of this site? Confirm its status | Bellaire | United States | Unknown status |
| The Retina Center Of New Jersey, LLC - Bloomfield Coordinator of this site? Confirm its status | Bloomfield | United States | Unknown status |
| Star Vision Consultants Coordinator of this site? Confirm its status | Burleson | United States | Unknown status |
| IN AVRUC Associated Vitreoretinal and Uveitis Consultants Coordinator of this site? Confirm its status | Carmel | United States | Unknown status |
| Charleston Neuroscience Institute LLC - Charleston Coordinator of this site? Confirm its status | Charleston | United States | Unknown status |
| Pepose Vision Institute Coordinator of this site? Confirm its status | Chesterfield | United States | Unknown status |
| Illinois Eye and Ear Infirmary at UI Health UIC Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| Illinois Retina Associates, S.C. - Lincoln Park Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| The Macula Center - Clearwater Office (Suncoast Retina Consultants, LLC) Coordinator of this site? Confirm its status | Clearwater | United States | Unknown status |
| Retina Associates of Cleveland Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
| Retina Consultants of Southern Colorado - Colorado Springs Coordinator of this site? Confirm its status | Colorado Springs | United States | Unknown status |
| Rand Eye Institute Coordinator of this site? Confirm its status | Deerfield Beach | United States | Unknown status |
| Speciality Retina Center Coordinator of this site? Confirm its status | Deerfield Beach | United States | Unknown status |
| RSC Research, PLLC Coordinator of this site? Confirm its status | Denver | United States | Unknown status |
| Henry Ford Hospital Coordinator of this site? Confirm its status | Detroit | United States | Unknown status |
| Duke University Health System - Duke Eye Center Of North Durham Coordinator of this site? Confirm its status | Durham | United States | Unknown status |
| Retina Consultants of Minnesota Coordinator of this site? Confirm its status | Edina | United States | Unknown status |
| The Retina Partners - Encino 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 |
| Palmetto Retina Center Coordinator of this site? Confirm its status | Florence | United States | Unknown status |
| Retina Group of Florida - Fort Lauderdale Coordinator of this site? Confirm its status | Fort Lauderdale | United States | Unknown status |
| Retina Consultants of Orange County - Fullerton Coordinator of this site? Confirm its status | Fullerton | United States | Unknown status |
| Charles Retina Institute PC Coordinator of this site? Confirm its status | Germantown | United States | Unknown status |
| Associated Retina Consultants - Gilbert Coordinator of this site? Confirm its status | Gilbert | United States | Unknown status |
| Mid Atlantic Retina Specialists - Hagerstown 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 |
| Long Island Vitreoretinal Consultants (VRC) - Hauppauge Coordinator of this site? Confirm its status | Hauppauge | 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 |
| Retina Partners Midwest Coordinator of this site? Confirm its status | Indianapolis | United States | Unknown status |
| Lakeside Vision Center - Irvine Coordinator of this site? Confirm its status | Irvine | United States | Unknown status |
| Mississippi Baptist Medical Center Coordinator of this site? Confirm its status | Jackson | United States | Unknown status |
| Retina Consultants of Texas - Katy Coordinator of this site? Confirm its status | Katy | United States | Unknown status |
| Charleston Neuroscience Institute Coordinator of this site? Confirm its status | Ladson | United States | Unknown status |
| Florida Retina Consultants - Lakeland Coordinator of this site? Confirm its status | Lakeland | United States | Unknown status |
| Florida Retina Institute - Lake Mary Coordinator of this site? Confirm its status | Lake Mary | United States | Unknown status |
| Colorado Retina Associates (CRA) - Lakewood Coordinator of this site? Confirm its status | Lakewood | United States | Unknown status |
| Retina-Vitreous Surgeons of Central New York Coordinator of this site? Confirm its status | Liverpool | United States | Unknown status |
| Retina-Vitreous Associates Medical Group - Los Angeles Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| South Florida Retina Institute Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| CA RCMG Retinal Consultants Medical Group, Inc. Coordinator of this site? Confirm its status | Modesto | United States | Unknown status |
| Retina Sacramento MSO, LLC Coordinator of this site? Confirm its status | Modesto | United States | Unknown status |
| Retina Consultants of Charleston - Mount Pleasant Coordinator of this site? Confirm its status | Mt. Pleasant | United States | Unknown status |
| Tennessee Retina, PC - Nashville - Centennial Professional Plaza Location Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| Wagner Macula & Retina Center - Norfolk, VA Office Coordinator of this site? Confirm its status | Norfolk | United States | Unknown status |
| University Retina and Macula Associates, P.C. 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 |
| CA CRC California Retina Consultants Coordinator of this site? Confirm its status | Oxnard | 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 |
| Doheny Eye Center Coordinator of this site? Confirm its status | Pasadena | United States | Unknown status |
| AzulVision Coordinator of this site? Confirm its status | Pasadena | United States | Unknown status |
| Retina Specialty Institute - Pensacola Coordinator of this site? Confirm its status | Pensacola | United States | Unknown status |
| Retinal Research Institute Coordinator of this site? Confirm its status | Phoenix | United States | Unknown status |
| Associated Retina Consultants - Phoenix Coordinator of this site? Confirm its status | Phoenix | United States | Unknown status |
| Maine Eye Center - Marginal Way Campus Coordinator of this site? Confirm its status | Portland | United States | Unknown status |
| Black Hills Regional Eye Institute (BHREI) 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 Vision and Surgery Specialists Coordinator of this site? Confirm its status | Roanoke | United States | Unknown status |
| Associated Retinal Consultants P.C. (ARC) - Royal Oak Coordinator of this site? Confirm its status | Royal Oak | United States | Unknown status |
| Retina Associates of Utah, P.C - Intermountain Medical Center Location Coordinator of this site? Confirm its status | Salt Lake City | United States | Unknown status |
| Medical Center Ophthalmology Associates (MCOA) - Northwest Clinic Location Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
| Retinal Consultants of Texas - San Antonio Medical Center Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
| TX RCTX 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 (CRC) - Santa Barbara 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 |
| NY LIVRC Long Island Vitreoretinal Consultants Coordinator of this site? Confirm its status | Shirley | United States | Unknown status |
| Vance Thompson Vision Coordinator of this site? Confirm its status | Sioux Falls | United States | Unknown status |
| MedEye Associates - Miami Coordinator of this site? Confirm its status | South Miami | United States | Unknown status |
| Springfield Clinic Coordinator of this site? Confirm its status | Springfield | United States | Unknown status |
| Retina Research Institute, LLC Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
| Retina Vitreous Associates of Florida (RVA) - Saint Petersburg Coordinator of this site? Confirm its status | St. Petersburg | United States | Unknown status |
| Retina Vitreous Associates of Florida - Tampa Coordinator of this site? Confirm its status | Tampa | United States | Unknown status |
| Retina Associates of Florida LLC Tampa MacDill Coordinator of this site? Confirm its status | Tampa | United States | Unknown status |
| Retina Consultants of Houston Coordinator of this site? Confirm its status | The Woodlands | United States | Unknown status |
| Macula Retina Vitreous Center Coordinator of this site? Confirm its status | Torrance | United States | Unknown status |
| Bay Area Retina Associates, A Medical Group Coordinator of this site? Confirm its status | Walnut Creek | United States | Unknown status |
| Retina Group of New England, PC Coordinator of this site? Confirm its status | Waterford | United States | Unknown status |
| Eye Clinic of Wisconsin Coordinator of this site? Confirm its status | Wausau | United States | Unknown status |
| Palmetto Retina Center Coordinator of this site? Confirm its status | West Columbia | United States | Unknown status |
| Wolfe Eye Clinic Coordinator of this site? Confirm its status | West Des Moines | United States | Unknown status |
| Retina Associates of Cleveland, Inc. - Youngstown Coordinator of this site? Confirm its status | Youngstown | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.