| Condition or Disease | Intervention/Treatment |
|---|---|
Neovascular Age-related Macular Degeneration | Drug: OTX-TKIDrug: AfliberceptDrug: Aflibercept |
ClinicalTrials.gov processed this data on June 2025. Link to the current ClinicalTrials.gov record .
| Condition or Disease | Intervention/Treatment |
|---|---|
Neovascular Age-related Macular Degeneration | Drug: OTX-TKIDrug: AfliberceptDrug: Aflibercept |
| Study Type | Interventional |
|---|---|
| Actual Enrollment | 825 participants |
| Design Allocation | Randomized |
| Interventional Model | Parallel Assignment |
| Masking | Quadruple |
| Primary Purpose | Treatment |
| Official Title | 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 |
| Study Start Date | November 26, 2024 |
| Actual Primary Completion Date | 8mos 5d from now |
| Actual Study Completion Date | 8mos 5d from now |
| Group/Cohort | Intervention/Treatment |
|---|---|
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| Ages Eligible for Study | (Adult, Older Adult) |
|---|---|
| Sexes Eligible for Study | All |
| Accepts Healthy Volunteers | No |
| Inclusion Criteria | 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 |
| Exclusion Criteria | 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. |
| Sponsors and Collaborators | Ocular Therapeutix, Inc. |
|---|---|
| Locations | Associated Retina Consultant | Gilbert Arizona, United States, 85297Associated Retina Consultants, Ltd. | Phoenix Arizona, United States, 85020Retinal Research Institute, LLC | Phoenix Arizona, United States, 85053Retina Macula Institute of Arizona | Scottsdale Arizona, United States, 85255California Retina Consultants | Bakersfield California, United States, 93309The Retina Partners | Encino California, United States, 91436Retina Consultants of Orange County | Fullerton California, United States, 92835Atlantis Eyecare | Huntington Beach California, United States, 92647Salehi Retina Institute, Inc., dba Retina Associates of Southern California | Huntington Beach California, United States, 92647Kaiser Permanente Division of Research | Oakland California, United States, 94611California Retina Consultants | Oxnard California, United States, 93036Stanford Health Care - Byers Eye Institute | Palo Alto California, United States, 94303Stanford University School of Medicine, Byers Eye Institute | Palo Alto California, United States, 94303California Eye Specialists Medical Group, INC | Pasadena California, United States, 91107Retinal Consultants Medical Group | Sacramento California, United States, 95841Orange County Retina Medical Group | Santa Ana California, United States, 92705California Retina Consultants | Santa Barbara California, United States, 93103Macula Retina Vitreous Research Institute | Torrance California, United States, 90503Bay Area Retina Associates | Walnut Creek California, United States, 94598Retina Consultants of Southern Colorado | Colorado Springs Colorado, United States, 80909RSC Research, LLC | Denver Colorado, United States, 80210Colorado Retina Associates | Lakewood Colorado, United States, 80228Retina Consultants, P.C | Manchester Connecticut, United States, 06042Retina Group of New England | Waterford Connecticut, United States, 06385Advanced Research LLC. | Deerfield Beach Florida, United States, 33064Rand Eye Institute | Deerfield Beach Florida, United States, 33064Retina Group of Florida | Fort Lauderdale Florida, United States, 33308Florida Retina Consultants | Lakeland Florida, United States, 33805South Florida Retina Institute | Miami Florida, United States, 33145Florida Retina Institude | Orlando Florida, United States, 32806Retina Specialty Institute | Pensacola Florida, United States, 32503MedEye Associates | South Miami Florida, United States, 33143Retina Vitreous Associates of Florida- Saint Petersburg | St. Petersburg Florida, United States, 33711Retina Vitreous Associates of Florida | Tampa Florida, United States, 33617Southeast Retina Center | Augusta Georgia, United States, 30909University Retina and Macula Associates, PC | Oak Forest Illinois, United States, 60452Illinois Retina Associates | Oak Park Illinois, United States, 60304Springfield Clinic Opthalmology Department | Springfield Illinois, United States, 62703Associate Vitreoretinal and Uveitis Consultants | Carmel Indiana, United States, 46032Retina Partners Midwest, P.C. | Carmel Indiana, United States, 46290Retina Partners Midwest | Indianapolis Indiana, United States, 46290Wolfe Clinic PC dba Wolfe Eye Clinic | West Des Moines Iowa, United States, 50026The Retina Group of Washington - Chevy Chase | Chevy Chase Maryland, United States, 20815Cumberland Valley Retina Consultants | Hagerstown Maryland, United States, 21740Mid Atlantic Retina Specialists | Hagerstown Maryland, United States, 21740Retina Specialists - Towson Office | Towson Maryland, United States, 21204Associated Retinal Consultants, P.C. | Royal Oak Michigan, United States, 48073Retina Consultants of Minnesota | Minneapolis Minnesota, United States, 55435Mississippi Retina Associates | Madison Mississippi, United States, 39110The Retina Institute | St Louis Missouri, United States, 63128Sierra Eye Associates | Reno Nevada, United States, 89502Envision Ocular, LLC | Bloomfield New Jersey, United States, 07003Vision Research Center Eye Associates of New Mexico | Albuquerque New Mexico, United States, 87109Retina Vitreous Surgeons of CNY, PC | Liverpool New York, United States, 13088Asheville Eye Associates (AEA) - Asheville | Asheville North Carolina, United States, 28803Cincinnati Eye Institute | Cincinnati Ohio, United States, 45242EyeHealth Northwest | Portland Oregon, United States, 97225Erie Retina Research | Erie Pennsylvania, United States, 16507Palmetto Retina Center, LLC | Aiken South Carolina, United States, 29802Charleston Neuroscience Instititute, LLC | Beaufort South Carolina, United States, 29902Palmetto Retina Center, LLC | Florence South Carolina, United States, 29501Palmetto Retina Center, LLC | West Columbia South Carolina, United States, 29169Black Hills Regional Eye Institute, LLP | Rapid City South Dakota, United States, 57701Charles Retina Institute | Germantown Tennessee, United States, 38138Southeastern Retina Associates PC | Johnson City Tennessee, United States, 37604Tennessee Retina, PC | Nashville Tennessee, United States, 37203Retina Research Institute of Texas | Abilene Texas, United States, 79606Texas Retina Associates | Arlington Texas, United States, 76012Austin Research Center for Retina | Austin Texas, United States, 78705Austin Retina Associates | Austin Texas, United States, 78705Retina Consultants of Texas | Beaumont Texas, United States, 77707Retina Consultants of Texas | Bellaire Texas, United States, 77401Star Vision Research | Burleson Texas, United States, 76028Texas Retina Associates | Dallas Texas, United States, 75231Texas Retina Center | Houston Texas, United States, 77030Retina Consultants of Texas | Katy Texas, United States, 77494Retina Consultants of Texas | San Antonio Texas, United States, 78240Retina Center of Texas | Southlake Texas, United States, 76092Retina Consultants of Texas | The Woodlands Texas, United States, 77384Retina Associates of Utah | Salt Lake City Utah, United States, 84107Rocky Mountain Retina Consultants | Salt Lake City Utah, United States, 84107Retina Group of Washington | Fairfax Virginia, United States, 22031Vistar Eye Center | Roanoke Virginia, United States, 24019Eye Clinic of Wisconsin, SC | Wausau Wisconsin, United States, 54403Organización Médica de Investigación (OMI) | Buenos Aires , Argentina, 1015Centro Privado de Ojos | Buenos Aires , Argentina, C1033AAWCharles Research Center (Centro Oftalmologico Dr. Charles S.A) | Buenos Aires , Argentina, C1121ABBBuenos Aires Macula | Caba , Argentina, C1061AAEInstituto Oftalmologico de Buenos Aires SA - OFTALMOS | Caba , Argentina, C1120AANFundacion Zambrano - Cirugia Ocular | Caba , Argentina, SFundacion Jorge Zambrano para la investigacion, Diagnostico y Tratamiento de las enfermedades oculares | Ciudad Autonoma de Buenos Aire , Argentina, C1023AAQOftar Mendoza Srl Centro Privado de Oftalmologia | Mendoza , Argentina, M5500GGKCentro Vision S.A. | Mendoza , Argentina, M5500Laser Vision Group | Rosario , Argentina, S2000Albury Eye Clinic | Albury New South Wales, Australia, 2640Marsden Eye Specialists (MES) - Parramatta | Parramatta New South Wales, Australia, 2150Emanuelli Research and Development Center, LLC | Arecibo , Puerto Rico, 612 |
| Investigators | Principal Investigator: Dilsher Dhoot, MD, California Retina Consultants (CRC) - Santa Barbara |
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