CompletedPhase 1

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

El Salvador22 participantsStarted 2022-03-24

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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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

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.

What they're measuring

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

Timeframe: 12 months

Incidence and severity of non-ocular TEAEs

Timeframe: 12 months

Trial details

NCT IDNCT05309135

SponsorAurion Biotech

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-03-09

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