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NCT07368959 · ClinicalTrials.gov registry record · Phase 3
AURN001 Efficacy in Participants With Corneal Edema Secondary to Corneal Endothelial Dysfunction
A Phase 3 study of Corneal Edema and Corneal Endothelial Dysfunction, sponsored by Aurion Biotech.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 120
- Enrollment target
- 12
- Study locations
NCT07368959: Recruiting Phase 3 study of Corneal Edema and Corneal Endothelial Dysfunction, sponsored by Aurion Biotech.
NCT07368959 is a Phase 3 study of Corneal Edema and Corneal Endothelial Dysfunction that is actively recruiting participants, run by Aurion Biotech. The registered enrollment target is 120 participants, above the 54-participant average among 4 other Corneal Edema trials with a reported enrollment target (122% higher). The trial reports 12 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07368959, a Phase 3 study of Corneal Edema and Corneal Endothelial Dysfunction, is actively recruiting participants, sponsored by Aurion Biotech.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 120 participants
- Enrollment target
- 12
- Study locations
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.
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Combination Product: AURN001 + Y-27632
Study Locations (12)
North Carolina
- Investigational Site 11 - Leland
- Investigational Site 5 - Winston-Salem
Pennsylvania
- Investigational Site 3 - Cynwyd
- Investigational Site 10 - Plymouth Meeting
Texas
- Investigational Site 8 - San Antonio
- Investigational Site 1 - Spring
Arizona
- Investigational Site 2 - Mesa
Arkansas
- Investigational Site 6 - Little Rock
Colorado
- Investigational Site 9 - Fort Collins
Georgia
- Investigational Site 7 - Atlanta
Missouri
- Investigational Site 4 - Kansas City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2026-02-19 |
| Est. Completion | 2028-01 |
| Phase | Phase 3 |
What NCT07368959 shows while recruiting
NCT07368959 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, above the 54-participant average among 4 other Corneal Edema trials with a reported enrollment target (122% higher).
The record links to 4 conditions, with Corneal Edema appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT07368959 lists 12 locations in 9 states (North Carolina, Pennsylvania, Texas).
Frequently Asked Questions
What is clinical trial NCT07368959 about?
NCT07368959 is a clinical study titled "AURN001 Efficacy in Participants With Corneal Edema Secondary to Corneal Endothelial Dysfunction". 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.
What is the current status of trial NCT07368959?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 120 participants. The study started on 2026-02-19. Estimated completion is 2028-01.
What conditions does trial NCT07368959 study?
This clinical trial studies the following conditions: Corneal Edema, Corneal Endothelial Dysfunction, Fuchs Endothelial Corneal Dysfunction, Pseudophakic Bullous Keratopathy (PBK).
What interventions are being tested in trial NCT07368959?
The interventions under investigation include: Placebo (OTHER), Combination Product: AURN001 + Y-27632 (DRUG).
Who is sponsoring clinical trial NCT07368959?
This trial is sponsored by Aurion Biotech, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07368959 being conducted?
This trial has 12 study locations across Arizona, Arkansas, Colorado, Georgia, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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