Corneal Edema Clinical Trial
— CLARAOfficial title:
CLARA: A Phase 1/2 Multi-center, Randomized, Double-Masked, Prospective, Parallel-Arm Study of AURN001 in Subjects With Corneal Edema Secondary to Corneal Endothelial Dysfunction (ABA-1)
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.
| Status | Recruiting |
| Enrollment | 100 |
| Est. completion date | October 2025 |
| Est. primary completion date | October 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 99 Years |
| Eligibility | Inclusion Criteria: - 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) Exclusion Criteria: - 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 |
| Country | Name | City | State |
|---|---|---|---|
| Canada | Aurion Biotech site | Oakville | Ontario |
| Canada | Aurion Biotech site | Toronto | Ontario |
| Canada | Aurion Biotech site | Vancouver | British Columbia |
| United States | Aurion Biotech site | Atlanta | Georgia |
| United States | Aurion Biotech site | Bala-Cynwyd | Pennsylvania |
| United States | Aurion Biotech site | Cincinnati | Ohio |
| United States | Aurion Biotech site | Garden City | New York |
| United States | Aurion Biotech site | Houston | Texas |
| United States | Aurion Biotech site | Houston | Texas |
| United States | Aurion Biotech site | Indianapolis | Indiana |
| United States | Aurion Biotech site | Little Rock | Arkansas |
| United States | Aurion Biotech site | Los Angeles | California |
| United States | Aurion Biotech site | Minnetonka | Minnesota |
| United States | Aurion Biotech site | Norfolk | Virginia |
| United States | Aurion Biotech site | Oklahoma City | Oklahoma |
| United States | Aurion Biotech site | San Francisco | California |
| United States | Aurion Biotech site | Seattle | Washington |
| United States | Aurion Biotech site | Sioux Falls | South Dakota |
| United States | Aurion Biotech site | Wichita | Kansas |
| United States | Aurion Biotech site | Winston-Salem | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Aurion Biotech |
United States, Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | BCVA - 15-letter improvement (3-line gain) | Response, defined as a =15-letter improvement (3-line gain) from baseline in best-corrected visual acuity (BCVA) | Month 6 |
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