Phase 3 Study of Single Injection AURN001 for Treating Corneal Edema Due to Corneal Endothelial Dysfunction in Adults

What this Trial Is About

Researchers are evaluating the effectiveness and safety of a single injection of AURN001 compared to a placebo in adults with corneal edema caused by corneal endothelial dysfunction. This randomized, double-masked Phase 3 study focuses on improving vision in participants who have this eye condition and may require surgery. Participants will receive either a single dose of AURN001 or a single dose of a placebo, both injected into the anterior chamber of the eye. The study uses a quadruple masking design to ensure unbiased results, comparing these two groups to assess changes in vision and corneal thickness over six months. During the study, participants best corrected visual acuity BCVA and central corneal thickness CCT will be measured at the start and again at six months. The main outcome is the percentage of participants who improve their vision by at least 15 letters on the ETDRS scale at six months. Safety and other changes in eye health will also be monitored throughout the trial, which is expected to continue until January 2028.

AURN001 Efficacy in Participants With Corneal Edema Secondary to Corneal Endothelial Dysfunction