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

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05309135

Acronym

Escalon

Enrollment

Registered

2022-04-04

Start date

2022-03-24

Completion date

2023-03-09

Last updated

2024-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Corneal Edema

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.

Interventions

DRUGHCEC-1

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

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

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame
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

Countries

El Salvador

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026