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

Phase 1

Completed

• Conditions: Corneal Edema
• Interventions: Drug: HCEC-1

• Registration Number: NCT05309135
• Lead Sponsor: Aurion Biotech

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-03-16
• Study Start: 2022-03-24
• Study First Submitted QC: 2022-03-24
• Study First Posted: 2022-04-04
• Primary Completion: 2023-03-09
• Study Completion: 2023-03-09
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-16
• Last Update Posted: 2024-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low dose Rho kinase inhibitor Y-27632	HCEC-1	Low dose Rho kinase inhibitor Y-27632
Mid dose Rho kinase inhibitor Y-27632	HCEC-1	Mid dose Rho kinase inhibitor Y-27632
High dose Rho kinase inhibitor Y-27632	HCEC-1	High dose Rho kinase inhibitor Y-27632

Primary Outcome Measures

Name	Time	Method
Incidence and severity of Treatment Emergent Ocular Adverse Events (TEAEs)	12 months
Incidence and severity of non-ocular TEAEs	12 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Site; 🇸🇻 San Salvador, El Salvador