A Phase 1, Double-Masked, Randomized, Safety and Efficacy, Single Center Clinical Evaluation of Corneal Injection for Endothelial Dysfunction Using Human Corneal Endothelial Cell Therapy (HCEC-1) in Adult Subjects With Corneal Edema Secondary to Endothelial Dysfunction

Aurion Biotech1 site in 1 country22 target enrollmentMarch 24, 2022

ConditionsCorneal Edema

InterventionsHCEC-1

DrugsHCEC-1

Overview

Phase: Phase 1
Intervention: HCEC-1
Conditions: Corneal Edema
Sponsor: Aurion Biotech
Enrollment: 22
Locations: 1
Primary Endpoint: Incidence and severity of Treatment Emergent Ocular Adverse Events (TEAEs)
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

March 24, 2022

End Date

March 9, 2023

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Aurion Biotech

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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
•Clinical diagnosis of corneal edema secondary to endothelial dysfunction
•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

Exclusion Criteria

•Keratoconus or other conditions of corneal thinning/ectasia
•Progressive stromal or anterior corneal dystrophies
•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
•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.
•Relative Afferent Pupillary Defect (RAPD) in the study eye
•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.

Arms & Interventions

Low dose Rho kinase inhibitor Y-27632

Intervention: HCEC-1

Mid dose Rho kinase inhibitor Y-27632

Intervention: HCEC-1

High dose Rho kinase inhibitor Y-27632

Intervention: HCEC-1

Outcomes

Primary Outcomes

Incidence and severity of Treatment Emergent Ocular Adverse Events (TEAEs)

Time Frame: 12 months

Incidence and severity of non-ocular TEAEs

Time Frame: 12 months

Secondary Outcomes

Change from baseline in Best-Corrected Visual Acuity (BCVA) as measured by LogMAR score(12 months)
Change from baseline in Central Corneal Thickness (CCT) as measured by pachymetry(12 months)