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NCT07368959PHASE3Recruiting

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

Aurion Biotech

Start Date

2/19/2026

Completion Date

1/1/2028

Summary

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

Age Range: 18 years to No maximum

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.

Interventions

DRUG

Combination Product: AURN001 + Y-27632

OTHER

Placebo

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Conditions

Corneal EdemaCorneal Endothelial DysfunctionFuchs Endothelial Corneal DysfunctionPseudophakic Bullous Keratopathy (PBK)

Locations

Investigational Site 2

Mesa, Arizona 85206

United States

Investigational Site 6

Little Rock, Arkansas 72205

United States

Investigational Site 9

Fort Collins, Colorado 80528

United States

Investigational Site 7

Atlanta, Georgia 30339

United States

Investigational Site 4

Kansas City, Missouri 64154

United States

Investigational Site 11

Leland, North Carolina 28451

United States

Investigational Site 5

Winston-Salem, North Carolina 27157

United States

Investigational Site 3

Cynwyd, Pennsylvania 19004

United States

Investigational Site 10

Plymouth Meeting, Pennsylvania 19462

United States

Investigational Site 12

Ladson, South Carolina 29456

United States

Investigational Site 8

San Antonio, Texas 78209

United States

Investigational Site 1

Spring, Texas 77388

United States