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
NCT ID: NCT05309135
Last Updated: 2024-08-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
22 participants
INTERVENTIONAL
2022-03-24
2023-03-09
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Low dose Rho kinase inhibitor Y-27632
Low dose Rho kinase inhibitor Y-27632
HCEC-1
HCEC-1 = human cultured corneal endothelial cells and Rho kinase Y-27632 inhibitor
Mid dose Rho kinase inhibitor Y-27632
Mid dose Rho kinase inhibitor Y-27632
HCEC-1
HCEC-1 = human cultured corneal endothelial cells and Rho kinase Y-27632 inhibitor
High dose Rho kinase inhibitor Y-27632
High dose Rho kinase inhibitor Y-27632
HCEC-1
HCEC-1 = human cultured corneal endothelial cells and Rho kinase Y-27632 inhibitor
Interventions
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HCEC-1
HCEC-1 = human cultured corneal endothelial cells and Rho kinase Y-27632 inhibitor
Eligibility Criteria
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Inclusion Criteria
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
Exclusion Criteria
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.
18 Years
ALL
No
Sponsors
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Aurion Biotech
INDUSTRY
Responsible Party
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Locations
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Site
San Salvador, , El Salvador
Countries
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Other Identifiers
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AB-HCEC-1-004
Identifier Type: -
Identifier Source: org_study_id
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