Prospective, Randomized Trial of Basiliximab (Simulect) in the Prophylaxis of High-Risk Keratoplasty Patients
Status:
Completed
Trial end date:
2005-12-01
Target enrollment:
Participant gender:
Summary
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.