NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

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

RecruitingPhase 3

Sponsor: Aurion Biotech

Conditions: Corneal Edema, Corneal Endothelial Dysfunction, Fuchs Endothelial Corneal Dysfunction, Pseudophakic Bullous Keratopathy (PBK)

Interventions: Combination Product: AURN001 + Y-27632, Placebo

Countries: United States

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Key Ocular Inclusion Criteria:

(All ocular criteria apply to the study eye unless noted otherwise)

* 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

Key Ocular Exclusion Criteria:

(All ocular criteria apply to the study eye unless noted otherwise)

* Have progressive corneal dystrophies or degenerations
* Have visually significant corneal or other ocular pathologies

Other inclusion/exclusion criteria may apply.

Locations (12)

Mesa, Arizona, United States
Little Rock, Arkansas, United States
Fort Collins, Colorado, United States
Atlanta, Georgia, United States
Kansas City, Missouri, United States
Leland, North Carolina, United States
Winston-Salem, North Carolina, United States
Cynwyd, Pennsylvania, United States
Plymouth Meeting, Pennsylvania, United States
Ladson, South Carolina, United States
San Antonio, Texas, United States
Spring, Texas, United States