Status:
COMPLETED
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
Lead Sponsor:
Aurion Biotech
Conditions:
Corneal Edema
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 co...
Eligibility Criteria
Inclusion
- Key
- 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
- 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.
Key Trial Info
Start Date :
March 24 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 9 2023
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT05309135
Start Date
March 24 2022
End Date
March 9 2023
Last Update
August 19 2024
Active Locations (1)
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1
Site
San Salvador, El Salvador