A Phase 1/2 Study of AURN001 in Subjects With Corneal Edema Secondary to Corneal Endothelial Dysfunction (ABA-1)
Summary
The goal of this clinical trial is to compare different doses of AURN001 in patients with corneal edema secondary to corneal endothelial dysfunction. The main questions the clinical trial aims to answer are whether AURN001 effective and safe. Participants will receive a single injection of AURN001. A comparison between low, medium, and high doses of AURN001 against the contribution of each element, cells alone and Y27632 alone, will be conducted to determine the effects on corneal edema.
Timeline
- Start
- 2023-10-18
- Primary completion
- 2024-10-25
- Completion
- 2025-04-15
Outcome
Met primary endpoint
registry Y-27632 100 µM vs AURN001 (1.0 × 10^6 Neltependocel + Y-27632 100 µM); p = 0.0203 NCT06041256 ↗
release “For the primary endpoint, a dose-dependent response was observed in the three AURN001 arms, with a statistically significant improvement [1] in the high-dose AURN001 arm” aurionbiotech.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Neltependocel | Cell therapy | — | — |
| Subject | Y27632 | Small molecule | — | — |