Abstract
Background
The purpose of this prospective, randomised, multicentre study was to prove the efficacy and safety of mycophenolate mofetil (MMF) in preventing graft rejection and in improving clear graft survival following high-risk keratoplasty.
Methods
In all, 98 of 140 scheduled patients were included in this study (57 MMF, 41 control). Recruitment was stopped prematurely due to a statistically significant result. The patients in the MMF group received MMF orally 2 × 1 g daily for 6 months. All of the patients received fluocortolone 1 mg/kg/day tapered over 3 weeks and topical prednisolone acetate 5 × /day tapered over 5 months. Main criteria were immune reaction-free and clear graft survival, and the occurrence of side effects.
Results
The mean follow-up time was 34.9±16.3 (mean±SD) months. Eleven patients withdrew from the study (nine patients due to protocol deviation, two because of side effects). Six reversible and two irreversible graft rejections occurred in the MMF group, and five reversible and seven irreversible rejections in the control group. The Kaplan–Meier analysis revealed an 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). Graft failure occurred in 10 MMF-treated patients (two due to rejection) and in nine patients in the control group (seven due to rejection). A total of 36 of 57 MMF-treated patients experienced mostly reversible adverse events.
Conclusions
Systemic immunosuppression with MMF over 6 months is relatively well tolerated and improves rejection-free graft survival following high-risk keratoplasty statistically significant, even in the long run.
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Acknowledgements
We thank Roche Pharma AG, Grenzach-Wyhlen, Germany, for financial support of the study.
Further participating centres: University Eye Hospital Düsseldorf, Germany; University Eye Hospital, Erlangen, Germany; University Eye Hospital Hamburg, Germany; University Eye Hospital München, Germany; University Eye Hospital Münster, Germany; University Eye Hospital Halle, Germany; University Eye Hospital Homburg/Saar, Germany; University Eye Hospital Essen, Germany.
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This work was presented as free paper during the annual convention of the German Ophthalmological Society (DOG) in Berlin, 21–24 September 2006
Study registration number: NCT00411515; and ZKS UKF000727 (www.uniklinik-freiburg.de/zks/live/uklregister/Oeffentlich.html)
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Birnbaum, F., Mayweg, S., Reis, A. et al. Mycophenolate mofetil (MMF) following penetrating high-risk keratoplasty: long-term results of a prospective, randomised, multicentre study. Eye 23, 2063–2070 (2009). https://doi.org/10.1038/eye.2008.402
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DOI: https://doi.org/10.1038/eye.2008.402
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