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

NCT05309135 | Completed Phase 1

• 1 other identifier: AB-HCEC-1-004
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Corneal Edema

Outcome Measures

Primary Outcomes (2)

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

  12 months

• Incidence and severity of non-ocular TEAEs

  12 months

Secondary Outcomes (2)

• Change from baseline in Central Corneal Thickness (CCT) as measured by pachymetry

  12 months

• Change from baseline in Best-Corrected Visual Acuity (BCVA) as measured by LogMAR score

  12 months

Study Arms (3)

Low dose Rho kinase inhibitor Y-27632

ACTIVE COMPARATOR

Low dose Rho kinase inhibitor Y-27632

Drug: HCEC-1

Mid dose Rho kinase inhibitor Y-27632

ACTIVE COMPARATOR

Mid dose Rho kinase inhibitor Y-27632

Drug: HCEC-1

High dose Rho kinase inhibitor Y-27632

ACTIVE COMPARATOR

High dose Rho kinase inhibitor Y-27632

Drug: HCEC-1

Interventions

HCEC-1 DRUG

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

High dose Rho kinase inhibitor Y-27632; Low dose Rho kinase inhibitor Y-27632; Mid dose Rho kinase inhibitor Y-27632

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Aurion Biotech: lead

Study Sites (1)

Site

San Salvador, El Salvador

Location

MeSH Terms

Conditions

Corneal Edema

Condition Hierarchy (Ancestors)

Corneal Diseases; Eye Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Within the treated groups, the sponsor, investigator, assessor, and subject will be masked to the assigned dose.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2022
• First Posted: April 4, 2022
• Study Start: March 24, 2022
• Primary Completion: March 9, 2023
• Study Completion: March 9, 2023
• Last Updated: August 19, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

EL (1)