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

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ClinicalTrials.gov Identifier: NCT06041256
Recruitment Status : Recruiting
First Posted : September 18, 2023
Last Update Posted : April 5, 2024
Sponsor:
Information provided by (Responsible Party):
Aurion Biotech

Study Description
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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
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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
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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
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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
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Information from the National Library of Medicine

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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
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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
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Contact: Study Manager, OD 18576394161 clinicalaffairs@aurionbiotech.com

Locations
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United States, Arkansas
Aurion Biotech site Recruiting
Little Rock, Arkansas, United States, 72205
Contact: Clara Study       clinicalaffairs@aurionbiotech.com   
United States, California
Aurion Biotech site Recruiting
Los Angeles, California, United States, 90067
Contact: Clara Study       clinicalaffairs@aurionbiotech.com   
Aurion Biotech site Recruiting
San Francisco, California, United States, 94158
Contact: Clara Study       clinicalaffairs@aurionbiotech.com   
United States, Georgia
Aurion Biotech site Recruiting
Atlanta, Georgia, United States, 30339
Contact: Clara Study       clinicalaffairs@aurionbiotech.com   
United States, Indiana
Aurion Biotech site Recruiting
Indianapolis, Indiana, United States, 46260
Contact: Clara Study       clinicalaffairs@aurionbiotech.com   
United States, Kansas
Aurion Biotech site Recruiting
Wichita, Kansas, United States, 67206
Contact: Clara Study       clinicalaffairs@aurionbiotech.com   
United States, Minnesota
Aurion Biotech site Recruiting
Minnetonka, Minnesota, United States, 55305
Contact: Clara Study       clinicalaffairs@aurionbiotech.com   
United States, New York
Aurion Biotech site Recruiting
Garden City, New York, United States, 11576
Contact: Clara Study       clinicalaffairs@aurionbiotech.com   
United States, North Carolina
Aurion Biotech site Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Clara Study       clinicalaffairs@aurionbiotech.com   
United States, Ohio
Aurion Biotech site Recruiting
Cincinnati, Ohio, United States, 45242
Contact: Clara Study       clinicalaffairs@aurionbiotech.com   
United States, Oklahoma
Aurion Biotech site Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Clara Study       clinicalaffairs@aurionbiotech.com   
United States, Pennsylvania
Aurion Biotech site Recruiting
Bala-Cynwyd, Pennsylvania, United States, 19004
Contact: Clara Study       clinicalaffairs@aurionbiotech.com   
United States, South Dakota
Aurion Biotech site Recruiting
Sioux Falls, South Dakota, United States, 57108
Contact: Clara Study       clinicalaffairs@aurionbiotech.com   
United States, Texas
Aurion Biotech site Recruiting
Houston, Texas, United States, 77027
Contact: Clara Study       clinicalaffairs@aurionbiotech.com   
Aurion Biotech site Recruiting
Houston, Texas, United States, 77055
Contact: Clara Study       clinicalaffairs@aurionbiotech.com   
United States, Virginia
Aurion Biotech site Recruiting
Norfolk, Virginia, United States, 23502
Contact: Clara Study       clinicalaffairs@aurionbiotech.com   
United States, Washington
Aurion Biotech site Recruiting
Seattle, Washington, United States, 98125
Contact: Clara Study       cliniclaffairs@aurionbiotech.com   
Canada, British Columbia
Aurion Biotech site Recruiting
Vancouver, British Columbia, Canada, V5Z 1K1 CAN
Contact: Clara Study       clinicalaffairs@aurionbiotech.com   
Canada, Ontario
Aurion Biotech site Recruiting
Oakville, Ontario, Canada, L6H 0J8 CAN
Contact: Clara Study       clinicalaffairs@aurionbiotech.com   
Aurion Biotech site Recruiting
Toronto, Ontario, Canada, M5T 3A9 CAN
Contact: Clara Study       clinicalaffairs@aurionbiotech.com   
Sponsors and Collaborators
Aurion Biotech
Investigators
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Study Director: Study Manager, OD Aurion Biotech
More Information
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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: April 5, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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