ASTRA: A Phase 3 Multi-center, Randomized, Double-Masked, Prospective Study of AURN001 in Subjects With Corneal Edema Secondary to Corneal Endothelial Dysfunction (ABA-3)
Aurion Biotech
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
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 oth…
Interventions
- DrugCombination Product: AURN001 + Y-27632
AURN001 will be injected to the anterior chamber of the eye.
- OtherPlacebo
Placebo control will be injected to the anterior chamber of the eye.
Locations (12)
- Investigational Site 2Mesa, Arizona
- Investigational Site 6Little Rock, Arkansas
- Investigational Site 9Fort Collins, Colorado
- Investigational Site 7Atlanta, Georgia
- Investigational Site 4Kansas City, Missouri
- Investigational Site 11Leland, North Carolina