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

COMPLETEDPHASE1/PHASE2

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)

NCT06041256•Aurion Biotech

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 99 years

Sex

ALL

Healthy Volunteers

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

Locations (20)

Aurion Biotech site

Little Rock, Arkansas, United States

Aurion Biotech site

Los Angeles, California, United States

Aurion Biotech site

San Francisco, California, United States

Aurion Biotech site

Atlanta, Georgia, United States

Aurion Biotech site

Indianapolis, Indiana, United States

Aurion Biotech site

Wichita, Kansas, United States

Aurion Biotech site

Minnetonka, Minnesota, United States

Aurion Biotech site

Garden City, New York, United States

Aurion Biotech site

Winston-Salem, North Carolina, United States

Aurion Biotech site

Cincinnati, Ohio, United States

Key Dates

Start Date

October 18, 2023

Primary Completion Date

October 25, 2024

Completion Date

April 15, 2025

Last Updated

December 17, 2025

Enrollment

ACTUAL participants

Conditions

Corneal EdemaCorneal Endothelial Dysfunction

Interventions

AURN001

COMBINATION_PRODUCT

Corneal Endothelial Cells

BIOLOGICAL

Y27632

DRUG

The Belgian Endothelial Surgical Transplant of the Cornea

NCT05436665

Corneal EdemaCorneal Endothelial Disorder+3 more

View study

RECRUITING

Validation of the Use of Terahertz Scanning System on Corneal Scars and Corneal Edema

NCT06983652

Corneal DiseasesCorneal Scars and Opacities+1 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 17, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

The Belgian Endothelial Surgical Transplant of the Cornea

Validation of the Use of Terahertz Scanning System on Corneal Scars and Corneal Edema

Assessing eFficacy and Safety of DEXTENZA 0.4 mg inseRt, Following Cataract Surgery

EndoArt® Implantation in Subjects With Chronic Corneal Edema

A Phase 2 Study Evaluating the Safety and Efficacy of Netarsudil Ophthalmic Solution in Patients With Corneal Edema Due to Fuchs Corneal Dystrophy

Early Experience With Descemet's Stripping Automated Endothelial Keratoplasty