|Condition or Disease||Intervention / Treatment||Phase||Sponsor||Status|
| Neovascular "Wet"|
Age-Related Macular Degeneration
|3||Kodiak Science Inc.||Enrolling|
This is a Phase 3, prospective, randomized, double-masked, two-arm, multi-center non-inferiority study evaluating the efficacy and safety of repeated intravitreal dosing of KSI-301 5 mg in participants with visual impairment due to treatment-naïve neovascular (wet) age-related macular degeneration (wAMD). Participants will be randomized 1:1 into one of two treatment arms: KSI-301 or aflibercept.
The primary endpoint will be assessed at Week 40; additional secondary endpoints for efficacy will be assessed by visit over time.
For masking purposes, sham injections will be administered at every monthly visit if an active treatment is not administered. To preserve masking, two investigators are required for this study. The masked Investigator will be responsible for the examinations and safety assessments. The unmasked Investigator will perform the injections and post-treatment assessments.