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
- ACTIVE_NOT_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 (88)
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
Scroll for more (78 remaining)Associated Retina Consultant🇺🇸Gilbert, Arizona, United States