drugset / Trial / NCT00411515
A Prospective Randomized Trial on Mycophenolate Mofetil in Risk Penetrating Keratoplasty
RandomizedParallel-groupOpen-labelPrevention
Summary
The purpose of this prospectively randomized multicentre study was to prove the efficacy and safety of mycophenolate mofetil (MMF) to preventing graft rejection and improvement of clear graft survival following high-risk keratoplasty. The patients of the MMF group receive MMF orally 2x1 g daily for 6 months. Endpoints were immune reaction free and clear graft survival and the occurence of side-effects.
Timeline
- Start
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- Primary completion
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- Completion
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Outcome
Met primary endpoint
paper immune reaction-free graft survival after the mean follow-up time of 83% in the MMF group and 64.5% in the control group (P=0.044). PMID 19151659 ↗
paper improves rejection-free graft survival following high-risk keratoplasty statistically significant, even in the long run. PMID 19151659 ↗
Publications
- Results Reinhard T, Mayweg S, Sokolovska Y, Seitz B, Mittelviefhaus H, Engelmann K, Voiculescu A, Godehardt E, Sundmacher R. Systemic mycophenolate mofetil avoids immune reactions in penetrating high-risk keratoplasty: preliminary results of an ongoing prospectively randomized multicentre study. Transpl Int. 2005 Jun;18(6):703-8. doi: 10.1111/j.1432-2277.2005.00126.x.
- Birnbaum F, Mayweg S, Reis A, Bohringer D, Seitz B, Engelmann K, Messmer EM, Reinhard T. Mycophenolate mofetil (MMF) following penetrating high-risk keratoplasty: long-term results of a prospective, randomised, multicentre study. Eye (Lond). 2009 Nov;23(11):2063-70. doi: 10.1038/eye.2008.402. Epub 2009 Jan 16.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Mycophenolate Mofetil | Small molecule | 1 g | Oral |