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

Corneal Edema Clinical Trial

— Escalon  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05309135
• Other study ID #: AB-HCEC-1-004
• Status: Completed
• Phase: Phase 1
• Start date: March 24, 2022
• Est. completion date: March 9, 2023

Study information

• Verified date: July 2023
• Source: Aurion Biotech
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: March 9, 2023
• Est. primary completion date: March 9, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Corneal Edema
• Edema

Intervention

Drug:
• HCEC-1
HCEC-1 = human cultured corneal endothelial cells and Rho kinase Y-27632 inhibitor

Locations

Country	Name	City	State
El Salvador	Site	San Salvador

Sponsors (1)

Lead Sponsor	Collaborator
Aurion Biotech

Country where clinical trial is conducted

El Salvador, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence and severity of Treatment Emergent Ocular Adverse Events (TEAEs)		12 months
Primary	Incidence and severity of non-ocular TEAEs		12 months
Secondary	Change from baseline in Central Corneal Thickness (CCT) as measured by pachymetry		12 months
Secondary	Change from baseline in Best-Corrected Visual Acuity (BCVA) as measured by LogMAR score		12 months