Study to Evaluate the Efficacy and Safety of Intravitreal OTX-TKI (Axitinib Implant) in Subjects With Neovascular Age- Related Macular Degeneration
Phase 3
Recruiting
- Conditions
- Neovascular Age-related Macular Degeneration
- Interventions
- Drug: OTX-TKIDrug: Aflibercept
- 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
- RECRUITING
- Sex
- All
- Target Recruitment
- 825
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
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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.
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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 (5)
Retina Vitreous Associates of Florida- Saint Petersburg
🇺🇸Saint Petersburg, Florida, United States
Erie Retina Research
🇺🇸Erie, Pennsylvania, United States
Sierra Eye Associates
🇺🇸Reno, Nevada, United States
The Retina Center Of New Jersey, LLC - Bloomfield
🇺🇸Bloomfield, New Jersey, United States
Cumberland Valley Retina Consultants
🇺🇸Hagerstown, Maryland, United States
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