A Phase 1/2 Study of AURN001 in Subjects With Corneal Edema Secondary to Corneal Endothelial Dysfunction (ABA-1)

Completed · Phase 1/Phase 2

Conditions studied: Corneal Edema, Corneal Endothelial Dysfunction

In brief

The goal of this clinical trial is to compare different doses of AURN001 in patients with corneal edema secondary to corneal endothelial dysfunction. The main questions the clinical trial aims to answer are whether AURN001 effective and safe. Participants will receive a single injection of AURN001. A comparison between low, medium, and high doses of AURN001 against the contribution of each element, cells alone and Y27632 alone, will be conducted to determine the effects on corneal edema.

Key facts

Study ID

NCT06041256

Run by

Aurion Biotech

People needed

97

Starts

2023-10-18

Expected to finish

2025-04-15

Last updated by the study team

2025-12-17

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Have a diagnosis of corneal edema secondary to corneal endothelial dysfunction, requiring surgery (full- or partial-thickness endothelial keratoplasty)
• BCVA between 65 Early Treatment of Diabetic Retinopathy Study (ETDRS) letters (i.e., 0.4 LogMAR or approximate 20/50 Snellen equivalent) and 5 ETDRS letters (i.e., 1.6 LogMAR or approximate 20/800 Snellen equivalent)

You may not qualify if…

• Have pre-operative corneal epithelial, sub-epithelial or stromal scarring or other opacity that is paracentral/central and visually significant, but not suspected to be secondary to corneal endothelial disease with the potential to improve from treatment in the study eye
• Have history or presence of an ocular disease other than corneal endothelial dysfunction that could affect vision or safety assessments

Where it is running

• Aurion Biotech site — Little Rock, Arkansas, United States
• Aurion Biotech site — Los Angeles, California, United States
• Aurion Biotech site — San Francisco, California, United States
• Aurion Biotech site — Atlanta, Georgia, United States
• Aurion Biotech site — Indianapolis, Indiana, United States
• Aurion Biotech site — Wichita, Kansas, United States
• Aurion Biotech site — Minnetonka, Minnesota, United States
• Aurion Biotech site — Garden City, New York, United States
• Aurion Biotech site — Winston-Salem, North Carolina, United States
• Aurion Biotech site — Cincinnati, Ohio, United States
• Aurion Biotech site — Oklahoma City, Oklahoma, United States
• Aurion Biotech site — Bala-Cynwyd, Pennsylvania, United States
• Aurion Biotech site — Sioux Falls, South Dakota, United States
• Aurion Biotech site — Houston, Texas, United States
• Aurion Biotech site — Houston, Texas, United States
• Aurion Biotech site — Norfolk, Virginia, United States
• Aurion Biotech site — Seattle, Washington, United States
• Aurion Biotech site — Vancouver, British Columbia, Canada
• Aurion Biotech site — Oakville, Ontario, Canada
• Aurion Biotech site — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

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