NCT06041256

A Phase 1/2 Study of AURN001 in Subjects With Corneal Edema Secondary to Corneal Endothelial Dysfunction (ABA-1)

CLARA: A Phase 1/2 Multi-center, Randomized, Double-Masked, Prospective, Parallel-Arm Study of AURN001 in Subjects With Corneal Edema Secondary to Corneal Endothelial Dysfunction (ABA-1)

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 97 (actual)
• Sponsor: Aurion Biotech · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Corneal Edema
• Corneal Endothelial Dysfunction

Interventions

Type	Name	Description
COMBINATION_PRODUCT	AURN001	Corneal Endothelial Cells and Y27632
BIOLOGICAL	Corneal Endothelial Cells	Corneal Endothelial Cells
DRUG	Y27632	Y27632

Timeline

• Start date: 2023-10-18
• Primary completion: 2024-10-25
• Completion: 2025-04-15
• First posted: 2023-09-18
• Last updated: 2025-12-17
• Results posted: 2025-12-17

Locations

20 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study