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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
120
AURN001 will be injected to the anterior chamber of the eye.
Placebo control will be injected to the anterior chamber of the eye.
Investigational Site 2
Mesa, Arizona, United States
Investigational Site 6
Little Rock, Arkansas, United States
Investigational Site 9
Fort Collins, Colorado, United States
Percentage of participants who achieve a ≥ 15-letter improvement (3-line gain) from baseline in Best Corrected Visual Acuity (BCVA) at Month 6
Time frame: At Month 6
Change from baseline in non-contact Central Corneal Thickness (CCT) at Month 6
Time frame: Baseline (Day 1) and At Month 6
Change from baseline in BCVA at Month 6
Time frame: Baseline (Day 1) and At Month 6
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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
...and 2 more locations