Clinical Trials in the USA / NCT07368959
Active, not recruiting
Phase 3
AURN001 Efficacy in Participants With Corneal Edema Secondary to Corneal Endothelial Dysfunction
NCT07368959 · tracked via the Priya Life Science USA tracker
Condition(s) studied
Corneal EdemaCorneal Endothelial DysfunctionFuchs Endothelial Corneal DysfunctionPseudophakic Bullous Keratopathy (PBK)
Investigational drug(s) / intervention(s)
Combination Product: AURN001 + Y-27632Placebo
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.
Study 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
Key Ocular Inclusion Criteria:
(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
Key Ocular Exclusion Criteria:
(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
Other inclusion/exclusion criteria may apply.
Primary outcome measure(s)
- Percentage of participants who achieve a ≥ 15-letter improvement (3-line gain) from baseline in Best Corrected Visual Acuity (BCVA) at Month 6 — At Month 6
Trial sites (12)
| Facility | City | Region | Status |
|---|---|---|---|
| Investigational Site 2 | Mesa | Arizona | |
| Investigational Site 6 | Little Rock | Arkansas | |
| Investigational Site 9 | Fort Collins | Colorado | |
| Investigational Site 7 | Atlanta | Georgia | |
| Investigational Site 4 | Kansas City | Missouri | |
| Investigational Site 11 | Leland | North Carolina | |
| Investigational Site 5 | Winston-Salem | North Carolina | |
| Investigational Site 3 | Cynwyd | Pennsylvania | |
| Investigational Site 10 | Plymouth Meeting | Pennsylvania | |
| Investigational Site 12 | Ladson | South Carolina | |
| Investigational Site 8 | San Antonio | Texas | |
| Investigational Site 1 | Spring | Texas |
Other trials for the same condition
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07368959 on ClinicalTrials.gov ↗ ← All trials in the USA