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)

Sponsor

Aurion Biotech (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT06041256

Collaborator

(none)

100

Enrollment

Arms

Anticipated Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Corneal Edema Corneal Endothelial Dysfunction	Combination Product: AURN001	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Anticipated 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)

Anticipated Study Start Date :

Oct 1, 2023

Anticipated Primary Completion Date :

Oct 1, 2024

Anticipated Study Completion Date :

Oct 1, 2025

Arms and Interventions

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

Primary Outcome Measures

BCVA - 15-letter improvement (3-line gain) [Month 6]
Response, defined as a ≥15-letter improvement (3-line gain) from baseline in best-corrected visual acuity (BCVA)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 99 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Aurion Biotech

Investigators

Study Director: Study Manager, OD, Aurion Biotech

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Aurion Biotech

ClinicalTrials.gov Identifier:

NCT06041256

Other Study ID Numbers:

ABA-1

First Posted:

Sep 18, 2023

Last Update Posted:

Sep 18, 2023

Last Verified:

Feb 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Corneal Edema

Edema

Study Results

No Results Posted as of Sep 18, 2023