NCT06495918
Active, not recruiting
Phase 3
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
Overview
- Phase
- Phase 3
- Intervention
- OTX-TKI
- Conditions
- Neovascular Age-related Macular Degeneration
- Sponsor
- Ocular Therapeutix, Inc.
- Enrollment
- 825
- Locations
- 88
- Primary Endpoint
- Best Corrected Visual Acuity (BCVA)
- Status
- Active, not recruiting
- Last Updated
- 10 months ago
Overview
Brief Summary
Study to Evaluate the Efficacy and Safety of Intravitreal OTX-TKI (Axitinib Implant) in Subjects with Neovascular Age- Related Macular Degeneration
Investigators
Eligibility Criteria
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.
Arms & Interventions
OTX-TKI Re-dose
Intervention: OTX-TKI
Aflibercept 2mg on label
Intervention: Aflibercept
Aflibercept 8mg high dose
Intervention: Aflibercept
Outcomes
Primary Outcomes
Best Corrected Visual Acuity (BCVA)
Time Frame: Week 48
Mean change in Best Corrected Visual Acuity (BCVA) from baseline at Week 48
Study Sites (88)
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