NCT05309135

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Aurion Biotech · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Corneal Edema

Interventions

Type	Name	Description
DRUG	HCEC-1	HCEC-1 = human cultured corneal endothelial cells and Rho kinase Y-27632 inhibitor

Timeline

• Start date: 2022-03-24
• Primary completion: 2023-03-09
• Completion: 2023-03-09
• First posted: 2022-04-04
• Last updated: 2024-08-19

Locations

1 site across 1 country: El Salvador