Corneal Edema
Conditions
Brief summary
The purpose of this study is to assess the safety and efficacy of cryopreserved AURN001 in patients with corneal edema secondary to endothelial dysfunction.
Interventions
COMBINATION_PRODUCTCryopreserved AURN001
Corneal Endothelial Cells and Y27632
Sponsors
Aurion Biotech
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* Have a diagnosis of corneal edema secondary to corneal endothelial dysfunction, requiring surgery (full- or partial-thickness endothelial keratoplasty) * BCVA no worse than 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| BCVA - 15-letter improvement (3-line gain) | Month 6 | Response, defined as a ≥15-letter improvement (3-line gain) from baseline in best-corrected visual acuity (BCVA) |
Countries
El Salvador
Outcome results
None listed