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

December 16, 2025 updated by: Aurion Biotech

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)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
97

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1K1 CAN
        • Aurion Biotech site
    • Ontario
      • Oakville, Ontario, Canada, L6H 0J8 CAN
        • Aurion Biotech site
      • Toronto, Ontario, Canada, M5T 3A9 CAN
        • Aurion Biotech site
  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Aurion Biotech site
    • California
      • Los Angeles, California, United States, 90067
        • Aurion Biotech site
      • San Francisco, California, United States, 94158
        • Aurion Biotech site
    • Georgia
      • Atlanta, Georgia, United States, 30339
        • Aurion Biotech site
    • Indiana
      • Indianapolis, Indiana, United States, 46260
        • Aurion Biotech site
    • Kansas
      • Wichita, Kansas, United States, 67206
        • Aurion Biotech site
    • Minnesota
      • Minnetonka, Minnesota, United States, 55305
        • Aurion Biotech site
    • New York
      • Garden City, New York, United States, 11576
        • Aurion Biotech site
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Aurion Biotech site
    • Ohio
      • Cincinnati, Ohio, United States, 45242
        • Aurion Biotech site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Aurion Biotech site
    • Pennsylvania
      • Bala-Cynwyd, Pennsylvania, United States, 19004
        • Aurion Biotech site
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57108
        • Aurion Biotech site
    • Texas
      • Houston, Texas, United States, 77027
        • Aurion Biotech site
      • Houston, Texas, United States, 77055
        • Aurion Biotech site
    • Virginia
      • Norfolk, Virginia, United States, 23502
        • Aurion Biotech site
    • Washington
      • Seattle, Washington, United States, 98125
        • Aurion Biotech site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: AURN001 High
Neltependocel High and Rho-associated protein kinase
Combination product: AURN001
Corneal Endothelial Cells and Y27632
Experimental: AURN001 Medium
Neltependocel Medium and Rho-associated protein kinase
Combination product: AURN001
Corneal Endothelial Cells and Y27632
Experimental: AURN001 Low
Neltependocel Low and Rho-associated protein kinase
Combination product: AURN001
Corneal Endothelial Cells and Y27632
Experimental: ROCK
Rho-associated protein kinase (ROCK)
Drug: Y27632
Y27632
Experimental: Neltependocel
Neltependocel - High
Biological: Corneal Endothelial Cells
Corneal Endothelial Cells

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants Achieving ≥15-letter Improvement in Best-corrected Visual Acuity (BCVA) at Month 6 - Imputed Data
Time Frame: Month 6
Best-corrected visual acuity was assessed using Early Treatment Diabetic Retinopathy Study(ETDRS) method, standard for vision testing. Standardized Sloan letter charts with 5 letters per line, decreasing by 0.1 logarithm of minimum angle of resolution (LogMAR) per line, were used at 4 meters (or 1 meter if ≤19 letters were read, with +0.75 spherical power added). Each correct letter equaled one point (0.02 LogMAR), with 85 letters (0.0 LogMAR) corresponding to 20/20 Snellen, 70 letters (+0.3) to 20/40, and 35 letters (+1.0) to 20/200. A gain of ≥15 letters (0.3 LogMAR, 3 lines) was clinically meaningful. Data from the study eye only were included in the analysis. Participants read letters aloud, guessing encouraged, and all responses recorded for accuracy. Data presented represent number of participants with available BCVA measurements at Month 6, with those who had missing data, underwent rescue surgery before Month 6, or discontinued study prior to Month 6 imputed as non-responders.
Month 6

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in BCVA at Month 6
Time Frame: Baseline (Day 1) and at Month 6
Best-corrected visual acuity was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) method, the standard for vision testing. Standardized Sloan letter charts with five letters per line, decreasing by 0.1 logarithm of the minimum angle of resolution (LogMAR) per line, were used at 4 meters (or 1 meter if ≤19 letters were read, with +0.75 spherical power added). Each correct letter equaled one point (0.02 LogMAR), with 85 letters (0.0 LogMAR) corresponding to 20/20 Snellen, 70 letters (+0.3) to 20/40, and 35 letters (+1.0) to 20/200. A gain of ≥15 letters (0.3 LogMAR, 3 lines) was clinically meaningful. Data from the study eye only were included in the analysis. Participants read letters aloud, guessing encouraged, and all responses recorded for accuracy. Baseline was defined as the last measurement prior to the study drug injection on Day 1. Change from baseline values was calculated as follow-up visit minus baseline visit.
Baseline (Day 1) and at Month 6
Change From Baseline in Central Corneal Thickness (CCT) at Month 6
Time Frame: Baseline (Day 1) and at Month 6
Central corneal thickness was measured by pachymetry which is an essential anatomical marker for detecting the presence or absence of edema and serves as a supportive indicator of treatment efficacy. Baseline was defined as the last measurement prior to the study drug injection on Day 1. Change from baseline values was calculated as follow-up visit minus baseline visit.
Baseline (Day 1) and at Month 6
Percentage of Participants Achieving ≥15-letter Improvement in BCVA at All Timepoints - Observed Data
Time Frame: At Week 4 and at Months 2, 3, 4.5, 6, 9 and 12
Best-corrected visual acuity was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) method, the standard for vision testing. Standardized Sloan letter charts with five letters per line, decreasing by 0.1 logarithm of the minimum angle of resolution (LogMAR) per line, were used at 4 meters (or 1 meter if ≤19 letters were read, with +0.75 spherical power added). Each correct letter equaled one point (0.02 LogMAR), with 85 letters (0.0 LogMAR) corresponding to 20/20 Snellen, 70 letters (+0.3) to 20/40, and 35 letters (+1.0) to 20/200. A gain of ≥15 letters (0.3 LogMAR, 3 lines) was clinically meaningful. Data from the study eye only were included in the analysis. Participants read letters aloud, guessing encouraged, and all responses recorded for accuracy. The data presented reflect only participants with non-missing BCVA at each corresponding visit.
At Week 4 and at Months 2, 3, 4.5, 6, 9 and 12
Change From Baseline in BCVA at All Other Timepoints
Time Frame: Baseline (Day 1) and at Week 4, Months 2, 3, 4.5, 6, 9 and 12
Best-corrected visual acuity was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) method, the standard for vision testing. Standardized Sloan letter charts with five letters per line, decreasing by 0.1 logarithm of the minimum angle of resolution (LogMAR) per line, were used at 4 meters (or 1 meter if ≤19 letters were read, with +0.75 spherical power added). Each correct letter equaled one point (0.02 LogMAR), with 85 letters (0.0 LogMAR) corresponding to 20/20 Snellen, 70 letters (+0.3) to 20/40, and 35 letters (+1.0) to 20/200. A gain of ≥15 letters (0.3 LogMAR, 3 lines) was clinically meaningful. Data from the study eye only were included in the analysis. Participants read letters aloud, guessing encouraged, and all responses recorded for accuracy. Baseline was defined as the last measurement prior to the study drug injection on Day 1. Change from baseline values was calculated as follow-up visit minus baseline visit.
Baseline (Day 1) and at Week 4, Months 2, 3, 4.5, 6, 9 and 12
Change From Baseline in CCT at All Other Timepoints
Time Frame: Baseline (Day 1) and at Weeks 1 and 4, Months 2, 3, 4.5, 6, 9, and 12
Central corneal thickness was measured by pachymetry which is an essential anatomical marker for detecting the presence or absence of edema and serves as a supportive indicator of treatment efficacy. Baseline was defined as the last measurement prior to the study drug injection on Day 1. Change from baseline values was calculated as follow-up visit minus baseline visit.
Baseline (Day 1) and at Weeks 1 and 4, Months 2, 3, 4.5, 6, 9, and 12
Percentage of Participants Achieving ≥10-letter Improvement in BCVA at All Timepoints - Observed Data
Time Frame: At Week 4 and at Months 2, 3, 4.5, 6, 9 and 12
Best-corrected visual acuity was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) method, the standard for vision testing. Standardized Sloan letter charts with five letters per line, decreasing by 0.1 logarithm of the minimum angle of resolution (LogMAR) per line, were used at 4 meters (or 1 meter if ≤19 letters were read, with +0.75 spherical power added). Each correct letter equaled one point (0.02 LogMAR), with 85 letters (0.0 LogMAR) corresponding to 20/20 Snellen, 70 letters (+0.3) to 20/40, and 35 letters (+1.0) to 20/200. A gain of ≥15 letters (0.3 LogMAR, 3 lines) was clinically meaningful. Data from the study eye only were included in the analysis. Participants read letters aloud, guessing encouraged, and all responses recorded for accuracy. The data presented reflect only participants with non-missing BCVA at each corresponding visit.
At Week 4 and at Months 2, 3, 4.5, 6, 9 and 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Aurion Biotech

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Study Manager, OD, Aurion Biotech

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 18, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 25, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 15, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 11, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 11, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 18, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 17, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 16, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ABA-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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