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

Corneal Edema Clinical Trial

— CLARA  

Official title:

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06041256
• Other study ID #: ABA-1
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• Start date: October 18, 2023
• Est. completion date: October 2025

Study information

• Verified date: June 2024
• Source: Aurion Biotech
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: October 2025
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• Have a diagnosis of corneal edema secondary to corneal endothelial dysfunction, requiring surgery (full- or partial-thickness endothelial keratoplasty)

• BCVA between 65 Early Treatment of Diabetic Retinopathy Study (ETDRS) letters (i.e., 0.4 LogMAR or approximate 20/50 Snellen equivalent) and 5 ETDRS letters (i.e., 1.6 LogMAR or approximate 20/800 Snellen equivalent)

Exclusion Criteria:

• Have pre-operative corneal epithelial, sub-epithelial or stromal scarring or other opacity that is paracentral/central and visually significant, but not suspected to be secondary to corneal endothelial disease with the potential to improve from treatment in the study eye

• Have history or presence of an ocular disease other than corneal endothelial dysfunction that could affect vision or safety assessments

Related Conditions & MeSH terms

• Corneal Edema
• Edema

Intervention

Combination Product:
• AURN001
Corneal Endothelial Cells and Y27632

Locations

Country	Name	City	State
Canada	Aurion Biotech site	Oakville	Ontario
Canada	Aurion Biotech site	Toronto	Ontario
Canada	Aurion Biotech site	Vancouver	British Columbia
United States	Aurion Biotech site	Atlanta	Georgia
United States	Aurion Biotech site	Bala-Cynwyd	Pennsylvania
United States	Aurion Biotech site	Cincinnati	Ohio
United States	Aurion Biotech site	Garden City	New York
United States	Aurion Biotech site	Houston	Texas
United States	Aurion Biotech site	Houston	Texas
United States	Aurion Biotech site	Indianapolis	Indiana
United States	Aurion Biotech site	Little Rock	Arkansas
United States	Aurion Biotech site	Los Angeles	California
United States	Aurion Biotech site	Minnetonka	Minnesota
United States	Aurion Biotech site	Norfolk	Virginia
United States	Aurion Biotech site	Oklahoma City	Oklahoma
United States	Aurion Biotech site	San Francisco	California
United States	Aurion Biotech site	Seattle	Washington
United States	Aurion Biotech site	Sioux Falls	South Dakota
United States	Aurion Biotech site	Wichita	Kansas
United States	Aurion Biotech site	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Aurion Biotech

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BCVA - 15-letter improvement (3-line gain)	Response, defined as a =15-letter improvement (3-line gain) from baseline in best-corrected visual acuity (BCVA)	Month 6