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

Treatment

Study Type

Interventional

Phase

Phase 3

Gender

All

Healthy Volunteers

No

Minimum Age

50 Years

Maximum Age

N/A

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

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.