Trials / Recruiting
RecruitingNCT07368959
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)
- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- Sponsor
- Aurion Biotech · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Corneal Edema
- Corneal Endothelial Dysfunction
- Fuchs Endothelial Corneal Dysfunction
- Pseudophakic Bullous Keratopathy (PBK)
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Combination Product: AURN001 + Y-27632 | AURN001 will be injected to the anterior chamber of the eye. |
| OTHER | Placebo | Placebo control will be injected to the anterior chamber of the eye. |
Timeline
- Start date
- 2026-02-19
- Primary completion
- 2027-06-01
- Completion
- 2028-01-01
- First posted
- 2026-01-27
- Last updated
- 2026-04-08
Locations
12 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07368959. Inclusion in this directory is not an endorsement.