AURN001 Efficacy in Participants With Corneal Edema Secondary to Corneal Endothelial Dysfunction
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
120 participants
Feb 19, 2026
INTERVENTIONAL
Conditions
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
Inclusion Criteria4
- (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
Exclusion Criteria3
- (All ocular criteria apply to the study eye unless noted otherwise)
- Have progressive corneal dystrophies or degenerations
- Have visually significant corneal or other ocular pathologies
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Interventions
AURN001 will be injected to the anterior chamber of the eye.
Placebo control will be injected to the anterior chamber of the eye.
Locations(12)
View Full Details on ClinicalTrials.gov
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NCT07368959