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

Aurion Biotech

Status and phase: Completed; Phase 2; Phase 1

Conditions: Corneal Edema; Corneal Endothelial Dysfunction

Treatments: Combination Product: AURN001; Drug: Y27632; Biological: Corneal Endothelial Cells

Study type: Interventional

Funder types: Industry

Identifiers

NCT06041256

ABA-1

Details and patient eligibility

About

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.

Enrollment: 97 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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97 participants in 5 patient groups

AURN001 High

Experimental group

Description:

Neltependocel High and Rho-associated protein kinase

Treatment:

Combination Product: AURN001

AURN001 Medium

Experimental group

Description:

Neltependocel Medium and Rho-associated protein kinase

Treatment:

Combination Product: AURN001

AURN001 Low

Experimental group

Description:

Neltependocel Low and Rho-associated protein kinase

Treatment:

Combination Product: AURN001

Neltependocel

Experimental group

Description:

Neltependocel - High

Treatment:

Biological: Corneal Endothelial Cells

ROCK

Experimental group

Description:

Rho-associated protein kinase (ROCK)

Treatment:

Drug: Y27632