Escalon: 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

Sponsor

Aurion Biotech (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT05309135

Collaborator

(none)

Enrollment

Location

Arms

14.2

Anticipated Duration (Months)

2.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Corneal Edema	Drug: HCEC-1	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

Within the treated groups, the sponsor, investigator, assessor, and subject will be masked to the assigned dose.

Primary Purpose:

Treatment

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

Actual Study Start Date :

Mar 24, 2022

Anticipated Primary Completion Date :

Mar 31, 2023

Anticipated Study Completion Date :

May 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Low dose Rho kinase inhibitor Y-27632 10 µM Low dose Rho kinase inhibitor Y-27632 10 µM	Drug: HCEC-1 HCEC-1 = human cultured corneal endothelial cells and Rho kinase Y-27632 inhibitor
Active Comparator: Mid dose Rho kinase inhibitor Y-27632 50 µM Mid dose Rho kinase inhibitor Y-27632 50 µM	Drug: HCEC-1 HCEC-1 = human cultured corneal endothelial cells and Rho kinase Y-27632 inhibitor
Active Comparator: High dose Rho kinase inhibitor Y-27632 100 µM High dose Rho kinase inhibitor Y-27632 100 µM	Drug: HCEC-1 HCEC-1 = human cultured corneal endothelial cells and Rho kinase Y-27632 inhibitor

Arm

Intervention/Treatment

Active Comparator: Low dose Rho kinase inhibitor Y-27632 10 µM

Low dose Rho kinase inhibitor Y-27632 10 µM

Drug: HCEC-1

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

Active Comparator: Mid dose Rho kinase inhibitor Y-27632 50 µM

Mid dose Rho kinase inhibitor Y-27632 50 µM

Drug: HCEC-1

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

Active Comparator: High dose Rho kinase inhibitor Y-27632 100 µM

High dose Rho kinase inhibitor Y-27632 100 µM

Drug: HCEC-1

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

Outcome Measures

Primary Outcome Measures

Incidence and severity of Treatment Emergent Ocular Adverse Events (TEAEs) [12 months]
Incidence and severity of non-ocular TEAEs [12 months]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Key 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

Key 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinica Quesada	San Salvador		El Salvador

Sponsors and Collaborators

Aurion Biotech

Investigators

Principal Investigator: Rodrigo Quesada, MD, Clinica Quesada

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Aurion Biotech

ClinicalTrials.gov Identifier:

NCT05309135

Other Study ID Numbers:

AB-HCEC-1-004

First Posted:

Apr 4, 2022

Last Update Posted:

Apr 4, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Corneal Edema

Edema

Study Results

No Results Posted as of Apr 4, 2022