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ASTRA: A Phase 3 Randomized, Double-Masked Study of AURN001 Compared to Placebo in Adults With Corneal Edema Caused by Corneal Endothelial Dysfunction
Led by Aurion Biotech · Updated on 2026-05-22
120
Participants Needed
12
Research Sites
30 weeks
Total Duration
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AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of a single injection of AURN001 compared to a placebo in adults with corneal edema caused by corneal endothelial dysfunction. This randomized, double-masked Phase 3 study focuses on improving vision in participants who have this eye condition and may require surgery. Participants will receive either a single dose of AURN001 or a single dose of a placebo, both injected into the anterior chamber of the eye. The study uses a quadruple masking design to ensure unbiased results, comparing these two groups to assess changes in vision and corneal thickness over six months. During the study, participants' best corrected visual acuity (BCVA) and central corneal thickness (CCT) will be measured at the start and again at six months. The main outcome is the percentage of participants who improve their vision by at least 15 letters on the ETDRS scale at six months. Safety and other changes in eye health will also be monitored throughout the trial, which is expected to continue until January 2028.
CONDITIONS
Brief Title
AURN001 Efficacy in Participants With Corneal Edema Secondary to Corneal Endothelial Dysfunction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Have corneal edema secondary to corneal endothelial dysfunction requiring surgery (full- or partial-thickness endothelial keratoplasty)
- Best corrected visual acuity (BCVA) between approximately 20/50 and 20/800 in the study eye
- Be pseudophakic with a posterior chamber intraocular lens (PCIOL) in the study eye
- Adults aged 18 years or older
You will not qualify if you...
- Have progressive corneal dystrophies or degenerations in the study eye
- Have visually significant corneal or other ocular pathologies in the study eye
- Other inclusion or exclusion criteria may apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single dose with follow-up through Month 6
Participants receive a single injection of either the study drug AURN001 or placebo in the anterior chamber of the eye.
1 treatment visit and follow-up visits up to Month 6
Trial Site Locations
Total: 12 locations
1
Investigational Site 2
Mesa, Arizona, United States, 85206
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2
Investigational Site 6
Little Rock, Arkansas, United States, 72205
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3
Investigational Site 9
Fort Collins, Colorado, United States, 80528
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4
Investigational Site 7
Atlanta, Georgia, United States, 30339
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5
Investigational Site 4
Kansas City, Missouri, United States, 64154
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6
Investigational Site 11
Leland, North Carolina, United States, 28451
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7
Investigational Site 5
Winston-Salem, North Carolina, United States, 27157
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8
Investigational Site 3
Cynwyd, Pennsylvania, United States, 19004
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9
Investigational Site 10
Plymouth Meeting, Pennsylvania, United States, 19462
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10
Investigational Site 12
Ladson, South Carolina, United States, 29456
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11
Investigational Site 8
San Antonio, Texas, United States, 78209
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12
Investigational Site 1
Spring, Texas, United States, 77388
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Research Team
A
Aurion Study Team
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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