NCT06223958
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 (nAMD)
Overview
- Phase
- Phase 3
- Intervention
- OTX-TKI (axitinib implant)
- Conditions
- Neovascular Age-Related Macular Degeneration
- Sponsor
- Ocular Therapeutix, Inc.
- Enrollment
- 344
- Locations
- 105
- Primary Endpoint
- Best corrected visual acuity (BCVA)
- Status
- Active, not recruiting
- Last Updated
- last year
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 for Neovascular Age-Related Macular Degeneration (nAMD) in either eye at screening.
- •Are at least older than 50 years of age at Day
- •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
Exclusion Criteria
- •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.
Arms & Interventions
OTX-TKI (axitinib implant)
Intervention: OTX-TKI (axitinib implant)
Control
Intervention: Aflibercept
Outcomes
Primary Outcomes
Best corrected visual acuity (BCVA)
Time Frame: Up to 36 Weeks
Maintenance of visual acuity, defined as \< 15 Early Treatment Diabetic Retinopathy Study (ETDRS) letters Best corrected visual acuity (BCVA) loss
Study Sites (105)
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