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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low dose Rho kinase inhibitor Y-27632 | Active Comparator | Low dose Rho kinase inhibitor Y-27632 |
|
| Mid dose Rho kinase inhibitor Y-27632 | Active Comparator | Mid dose Rho kinase inhibitor Y-27632 |
|
| High dose Rho kinase inhibitor Y-27632 | Active Comparator | High dose Rho kinase inhibitor Y-27632 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HCEC-1 | Drug | HCEC-1 = human cultured corneal endothelial cells and Rho kinase Y-27632 inhibitor |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of Treatment Emergent Ocular Adverse Events (TEAEs) | 12 months | |
| Incidence and severity of non-ocular TEAEs | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in Central Corneal Thickness (CCT) as measured by pachymetry | 12 months | |
| Change from baseline in Best-Corrected Visual Acuity (BCVA) as measured by LogMAR score | 12 months |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site | San Salvador | El Salvador |
The study plan and protocol will be shared with the study center and other researchers per request.
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Within the treated groups, the sponsor, investigator, assessor, and subject will be masked to the assigned dose.
| ID | Term |
|---|---|
| D015715 | Corneal Edema |
| ID | Term |
|---|---|
| D003316 | Corneal Diseases |
| D005128 | Eye Diseases |
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