Back to resultsA 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) (CLARA)
Primary Purpose
Corneal Edema, Corneal Endothelial Dysfunction
Status
Not yet recruiting
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
AURN001
Sponsored by
About this trial
This is an interventional treatment trial for Corneal Edema
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
AURN001 High
AURN001 Medium
AURN001 Low
Neltependocel - High
ROCK
Arm Description
Neltependocel High and Rho-associated protein kinase
Neltependocel Medium and Rho-associated protein kinase
Neltependocel Low and Rho-associated protein kinase
Neltependocel - High
Rho-associated protein kinase (ROCK)
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT06041256
Brief Title
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)
Acronym
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)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
October 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aurion Biotech
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Corneal Edema, Corneal Endothelial Dysfunction
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
AURN001 High
Arm Type
Experimental
Arm Description
Neltependocel High and Rho-associated protein kinase
Arm Title
AURN001 Medium
Arm Type
Experimental
Arm Description
Neltependocel Medium and Rho-associated protein kinase
Arm Title
AURN001 Low
Arm Type
Experimental
Arm Description
Neltependocel Low and Rho-associated protein kinase
Arm Title
Neltependocel - High
Arm Type
Experimental
Arm Description
Neltependocel - High
Arm Title
ROCK
Arm Type
Experimental
Arm Description
Rho-associated protein kinase (ROCK)
Intervention Type
Combination Product
Intervention Name(s)
AURN001
Intervention Description
Corneal Endothelial Cells and Y27632
Primary Outcome Measure Information:
Title
BCVA - 15-letter improvement (3-line gain)
Description
Response, defined as a ≥15-letter improvement (3-line gain) from baseline in best-corrected visual acuity (BCVA)
Time Frame
Month 6
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Study Manager, OD
Phone
18576394161
Email
clara.study.@aurionbiotech.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Manager, OD
Organizational Affiliation
Aurion Biotech
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
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)
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