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NCT Number: 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

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.

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Key information

Conditions

Corneal Edema Corneal Diseases Eye Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Site

San Salvador, El Salvador

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

HCEC-1

Drug

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

Primary outcomes

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

    Time frame: 12 months

  2. Incidence and severity of non-ocular TEAEs

    Time frame: 12 months

Secondary outcomes

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

    Time frame: 12 months

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

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Aurion Biotech

Industry

Registry information

Official study 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

Acronym: Escalon

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 4, 2022
Registry last updated
Aug 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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