Status:
COMPLETED
A Phase 1/2 Study of AURN001 in Subjects With Corneal Edema Secondary to Corneal Endothelial Dysfunction (ABA-1)
Lead Sponsor:
Aurion Biotech
Conditions:
Corneal Edema
Corneal Endothelial Dysfunction
Eligibility:
All Genders
18-99 years
Phase:
PHASE1
PHASE2
Brief Summary
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 answ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 18 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 15 2025
Estimated Enrollment :
97 Patients enrolled
Trial Details
Trial ID
NCT06041256
Start Date
October 18 2023
End Date
April 15 2025
Last Update
December 17 2025
Active Locations (20)
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1
Aurion Biotech site
Little Rock, Arkansas, United States, 72205
2
Aurion Biotech site
Los Angeles, California, United States, 90067
3
Aurion Biotech site
San Francisco, California, United States, 94158
4
Aurion Biotech site
Atlanta, Georgia, United States, 30339