Study of Cryopreserved AURN001 in Subjects With Corneal Edema Secondary to Corneal Endothelial Dysfunction

Aurion Biotech

Status and phase: Active, not recruiting; Phase 2

Conditions: Corneal Edema

Treatments: Combination Product: Cryopreserved AURN001

Study type: Interventional

Funder types: Industry

Identifiers

NCT06630169

APANECA

Details and patient eligibility

About

The purpose of this study is to assess the safety and efficacy of cryopreserved AURN001 in patients with corneal edema secondary to endothelial dysfunction.

Enrollment: 25 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 no worse than 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: None (Open label)

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25 participants in 3 patient groups

Arm 1

Other group

Description:

Endothelial polishing zone 1 (low)

Treatment:

Combination Product: Cryopreserved AURN001

Arm 2

Other group

Description:

Endothelial polishing zone 2 (medium)

Treatment:

Combination Product: Cryopreserved AURN001

Arm 3

Other group

Description:

Endothelial polishing zone 3 (high)

Treatment:

Combination Product: Cryopreserved AURN001