Prospective, Randomized Trial of Basiliximab (Simulect) in the Prophylaxis of High-Risk Keratoplasty Patients
1 other identifier
interventional
N/A
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
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Started Dec 2003
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Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2005
CompletedFirst Submitted
Initial submission to the registry
December 8, 2006
CompletedFirst Posted
Study publicly available on registry
December 11, 2006
CompletedDecember 13, 2006
December 1, 2006
December 8, 2006
December 12, 2006
Conditions
Outcome Measures
Primary Outcomes (1)
Graft rejection
Secondary Outcomes (1)
Clear graft survival
Interventions
Eligibility Criteria
You may qualify if:
- high risk keratoplasty
You may not qualify if:
- normal risk keratoplasty
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Abudou M, Wu T, Evans JR, Chen X. Immunosuppressants for the prophylaxis of corneal graft rejection after penetrating keratoplasty. Cochrane Database Syst Rev. 2015 Aug 27;2015(8):CD007603. doi: 10.1002/14651858.CD007603.pub2.
PMID: 26313245DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Thomas Reinhard, MD, Prof.
University Eye Hospital, Freiburg
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
December 8, 2006
First Posted
December 11, 2006
Study Start
December 1, 2003
Study Completion
December 1, 2005
Last Updated
December 13, 2006
Record last verified: 2006-12