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AURN001 Efficacy in Participants With Corneal Edema Secondary to Corneal Endothelial Dysfunction
Sponsor: 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.
Official title: 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)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
120
Start Date
2026-02-19
Completion Date
2028-01
Last Updated
2026-04-08
Healthy Volunteers
No
Conditions
Interventions
Combination Product: AURN001 + Y-27632
AURN001 will be injected to the anterior chamber of the eye.
Placebo
Placebo control will be injected to the anterior chamber of the eye.
Locations (12)
Investigational Site 2
Mesa, Arizona, United States
Investigational Site 6
Little Rock, Arkansas, United States
Investigational Site 9
Fort Collins, Colorado, United States
Investigational Site 7
Atlanta, Georgia, United States
Investigational Site 4
Kansas City, Missouri, United States
Investigational Site 11
Leland, North Carolina, United States
Investigational Site 5
Winston-Salem, North Carolina, United States
Investigational Site 3
Cynwyd, Pennsylvania, United States
Investigational Site 10
Plymouth Meeting, Pennsylvania, United States
Investigational Site 12
Ladson, South Carolina, United States
Investigational Site 8
San Antonio, Texas, United States
Investigational Site 1
Spring, Texas, United States