This is the classic website, which will be retired eventually. Please visit the modernized ClinicalTrials.gov instead.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06041256
Recruitment Status : Recruiting
First Posted : September 18, 2023
Last Update Posted : November 18, 2023
Sponsor:
Information provided by (Responsible Party):
Aurion Biotech

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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.

Condition or disease Intervention/treatment Phase
Corneal Edema Corneal Endothelial Dysfunction Combination Product: AURN001 Phase 1 Phase 2

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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)
Actual Study Start Date : October 18, 2023
Estimated Primary Completion Date : October 2024
Estimated Study Completion Date : October 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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: Neltependocel - High
Neltependocel - High
 Combination Product: AURN001
Corneal Endothelial Cells and Y27632
Experimental: ROCK
Rho-associated protein kinase (ROCK)
 Combination Product: AURN001
Corneal Endothelial Cells and Y27632


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. BCVA - 15-letter improvement (3-line gain) [ Time Frame: Month 6 ]
    Response, defined as a ≥15-letter improvement (3-line gain) from baseline in best-corrected visual acuity (BCVA)


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06041256


Contacts
Layout table for location contacts
Contact: Study Manager, OD 18576394161 clara.study.@aurionbiotech.com

Locations
Layout table for location information
United States, California
Aurion Biotech site Recruiting
Los Angeles, California, United States, 90067
Contact: Clara Study       clara.study@aurionbiotech.com   
United States, Indiana
Aurion Biotech site Recruiting
Indianapolis, Indiana, United States, 46260
Contact: Clara Study       clara.study@aurionbiotech.com   
United States, Kansas
Aurion Biotech site Recruiting
Wichita, Kansas, United States, 67206
Contact: Clara Study       clara.study@aurionbiotech.com   
United States, Minnesota
Aurion Biotech site Recruiting
Minnetonka, Minnesota, United States, 55305
Contact: Clara Study       clara.study@aurionbiotech.com   
United States, South Dakota
Aurion Biotech site Recruiting
Sioux Falls, South Dakota, United States, 57108
Contact: Clara Study       clara.study@aurionbiotech.com   
United States, Texas
Aurion Biotech site Recruiting
Houston, Texas, United States, 77027
Contact: Clara Study       clara.study@aurionbiotech.com   
Aurion Biotech site Recruiting
Houston, Texas, United States, 77055
Contact: Clara Study       clara.study@aurionbiotech.com   
United States, Washington
Aurion Biotech site Recruiting
Seattle, Washington, United States, 98125
Contact: Clara Study       clara.study@aurionbiotech.com   
Sponsors and Collaborators
Aurion Biotech
Investigators
Layout table for investigator information
Study Director: Study Manager, OD Aurion Biotech
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Aurion Biotech
ClinicalTrials.gov Identifier: NCT06041256    
Other Study ID Numbers: ABA-1
First Posted: September 18, 2023    Key Record Dates
Last Update Posted: November 18, 2023
Last Verified: November 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Corneal Edema
Edema
Corneal Diseases
Eye Diseases