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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
22
HCEC-1 = human cultured corneal endothelial cells and Rho kinase Y-27632 inhibitor
Site
San Salvador, El Salvador
Incidence and severity of Treatment Emergent Ocular Adverse Events (TEAEs)
Time frame: 12 months
Incidence and severity of non-ocular TEAEs
Time frame: 12 months
Change from baseline in Central Corneal Thickness (CCT) as measured by pachymetry
Time frame: 12 months
Change from baseline in Best-Corrected Visual Acuity (BCVA) as measured by LogMAR score
Time frame: 12 months
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