Corneal Transplantation Clinical Trial
Official title:
Prospective, Randomized Trial of Basiliximab (Simulect) in the Prophylaxis of High-Risk Keratoplasty Patients
Most high risk keratoplasties are currently performed under systemic immunosuppression.
Immunosuppressants are currently either Cyclosporine A or mycophenolate mofetile,
administered for around 6 months. Due to potentially severe adverse effects, new
immunosuppressive exerting less side effects would be desirable. Basiliximab is a
monoclonal, chimeric antibody, targeted specifically against the Interleukin-2-Rezeptor from
activated T-cells. This agent is known to specifically inhibit T-cell proliferation upon
intravenous application only twice following transplantation. Basiliximab has already been
demonstrated effective in kidney transplantation.
This investigation is a prospective, randomized clinical trial on orthotopic, high-risk
penetrating keratoplasty. Basiliximab is evaluated against systemic Cyclosporine A. Primary
endpoint is graft rejection. Secondary endpoint is clear graft survival.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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