A Safety and Efficacy Study of Corneal Injection for Endothelial Dysfunction Using Human Corneal Endothelial Cell Therapy in Subjects With Corneal Edema Secondary to Endothelial Dysfunction (Escalon)

Aurion Biotech

Status and phase: Completed; Phase 1

Conditions: Corneal Edema

Treatments: Drug: HCEC-1

Study type: Interventional

Funder types: Industry

Identifiers

NCT05309135

AB-HCEC-1-004

Details and patient eligibility

About

The purpose of this study is to assess the safety of a fixed dose of human corneal endothelial cells when administered with varying concentrations of Rho kinase inhibitor (Y-27632) in patients with corneal edema secondary to endothelial dysfunction.

Enrollment: 22 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

1. Must have given written informed consent (signed and dated by subject or legal guardian), and any authorizations required by local law and be able to comply with all study requirements
2. Clinical diagnosis of corneal edema secondary to endothelial dysfunction
3. Best Corrected Visual Acuity (BCVA) no worse than 20/800 ETDRS (1.6 LogMAR) or better than 20/63 (0.5 LogMAR) in the study eye

Key Exclusion Criteria:

1. Keratoconus or other conditions of corneal thinning/ectasia
2. Progressive stromal or anterior corneal dystrophies
3. Pre-operative corneal epithelial, sub-epithelial or stromal staining, 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 with HCEC-1
4. Prior ophthalmic surgery including cataract surgery except as noted above in Inclusion Criterion #4, corneal transplantation, glaucoma (MIGS, iridectomy, trabeculectomy, valve), or vitreo-retinal surgery, aphakia, anterior chamber-IOL or iris claw IOL, multifocal IOL.
5. Relative Afferent Pupillary Defect (RAPD) in the study eye
6. Uncontrolled glaucoma or an IOP greater than 24 mmHg that is not controlled with topical beta blockers alone at the time of the Screening Visit.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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22 participants in 3 patient groups

Low dose Rho kinase inhibitor Y-27632

Active Comparator group

Description:

Low dose Rho kinase inhibitor Y-27632

Treatment:

Drug: HCEC-1

Mid dose Rho kinase inhibitor Y-27632

Active Comparator group

Description:

Mid dose Rho kinase inhibitor Y-27632

Treatment:

Drug: HCEC-1

High dose Rho kinase inhibitor Y-27632

Active Comparator group

Description:

High dose Rho kinase inhibitor Y-27632

Treatment:

Drug: HCEC-1