Clinical Trials Logo

Clinical Trial 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.


Clinical Trial Description

n/a


Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


NCT number NCT00409656
Study type Interventional
Source University Hospital Freiburg
Contact
Status Completed
Phase Phase 2
Start date December 2003
Completion date December 2005

See also
  Status Clinical Trial Phase
Recruiting NCT01206127 - DSAEK- Postoperative Positioning and Transplant Dislocation N/A
Terminated NCT00764582 - Ocular Penetration of 1.5% Levofloxacin and 0.5% Moxifloxacin During Corneal Transplant Surgery Phase 4
Recruiting NCT05870566 - Pretreatment to Promote Graft Survival After Subsequent High-risk Corneal Transplantation [CrossCornealVision] N/A
Recruiting NCT02084745 - Timing of Glaucoma Drainage Device With Boston Keratoprosthesis N/A
Unknown status NCT00834782 - Comparison of DCT, ORA and GAT in Eyes After Penetrating Keratoplasty Phase 4
Withdrawn NCT00345020 - Deep Lamellar Endothelial Keratoplasty: Small Incision Technique
Completed NCT00000137 - Collaborative Corneal Transplantation Studies (CCTS) Phase 3
Recruiting NCT04339907 - Inflammatory Mediators of Glaucoma After Corneal Transplantation (AH-Tears) N/A
Active, not recruiting NCT00874835 - Corneal Endothelium Delivery Instrument Phase 2
Completed NCT00570648 - A Prospective Study of the Effect of Topical Sodium Hyaluronate Immediately Post-PKP on Time to Reepithelialization N/A
Enrolling by invitation NCT03461978 - Ultrahigh-resolution Optical Coherence Tomography Imaging of the Anterior Eye Segment Structures N/A
Not yet recruiting NCT05210478 - Intraoperative Optical Coherence Tomography for Ophthalmic Surgical Guidance - Cornea
Completed NCT01694914 - Comparative Study of Two Corneal Graft Storage Media: New Animal Compound Free Medium Versus Reference Medium Phase 3
Completed NCT03381794 - The German Keratoplasty Registry of the German Ophthalmological Society (DOG) N/A
Recruiting NCT03105466 - Prospective Study of Deep Anterior Lamellar Keratoplasty Using Acellular Porcine Cornea N/A
Recruiting NCT01018888 - Safety and Efficacy Study of Artificial Cornea Phase 4
Recruiting NCT04490902 - Clinical Study on the Treatment of Mixed Component Cornea for High Risk Keratoplasty N/A
Recruiting NCT04337944 - Endoscopic Assisted Anterior Hyaloid Peeling in Boston Type 1 Keratoprosthesis (KPro-HP-Endo) N/A
Completed NCT01547975 - Retrospective Analysis of Surgical Outcomes After Corneal Transplantation N/A
Terminated NCT00447642 - Study to Assess LX201 for Prevention of Corneal Allograft Rejection or Graft Failure in Subjects Who Have Experienced One or More Rejection Episodes Following Penetrating Keratoplasty Phase 3