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

ConditionsCorneal Edema Corneal Endothelial Dysfunction Fuchs Endothelial Corneal Dysfunction Pseudophakic Bullous Keratopathy (PBK)

Trial statusRecruiting

Trial phasePhase 3

Trial typeInterventional

Biological sexAll

Age18+

SponsorAurion Biotech

About this trial

The purpose of this study is to assess the efficacy and safety of single injection dose of AURN001 compared with placebo in adult participants with corneal edema secondary to corneal endothelial dysfunction.

Eligibility criteria

Qualifiers

Have corneal edema secondary to corneal endothelial dysfunction, requiring surgery (full- or partial-thickness endothelial keratoplasty)

BCVA between 65 ETDRS letters (approximate 20/50 Snellen equivalent) and 5 ETDRS letters (approximate 20/800 Snellen equivalent)

Be pseudophakic with PCIOL

Disqualifiers

Have progressive corneal dystrophies or degenerations

Have visually significant corneal or other ocular pathologies

Trial design

Treatments tested in this trial

Combination Product: AURN001 + Y-27632
Placebo

Treatment groups

120 Participants

are divided into 2 treatment groups

Locations

Arizona

Investigational Site 285206, Mesa United States

Arkansas

Investigational Site 672205, Little Rock United States

Colorado

Investigational Site 980528, Fort Collins United States

Georgia

Investigational Site 730339, Atlanta United States

Sponsors and collaborators

Aurion Biotech

Lead sponsor

Source ClinicalTrials.gov