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Study to Evaluate the Efficacy and Safety of Intravitreal OTX-TKI (Ocular Therapeutix) (Axitinib Implant) in Subjects With Neovascular Age-Related Macular Degeneration
About
Brief Summary
Study to Evaluate the Efficacy and Safety of Intravitreal OTX-TKI (axitinib implant) in Subjects with Neovascular Age-Related Macular Degeneration
Primary Purpose
Study Type
Phase
Eligibility
Gender
Healthy Volunteers
Minimum Age
Maximum Age
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 1.
- 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.
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Study Stats
Protocol No.
24-5013
Category
Eye/Ocular Disorders
Principal Investigator
Location
- UCLA Pasadena