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Systemic Mycophenolate Mofetil (MMF) as Immuno-prophylaxis in Allogeneic High-risk Penetrating Keratoplasty: First Results of a Randomized Multi-center trial
1Mayweg S., 1Sokolowska Y., 2Seitz B., 3Engelmann K., 4Mittelviefhaus H., 1Reinhard T.,
1Heinrich-Heine-Universität Düsseldorf, Universitäts-Augenklinik (Düsseldorf)
2Friedrich-Alexander-Universität, Augenklinik (Erlangen)
3Universitätsklinikum Hamburg-Eppendorf, Klinik und Poliklinik für Augenheilkunde (Hamburg)
4Albert-Ludwigs-Universität Freiburg, Augenklinik (Freiburg)
Background: Recently, we were able to demonstrate the effecacy and safety of MMF after penetrating high-risk keratoplasty in a randomised monocenter study. Here, first results of a randomised multicenter trial are presented.
Patients: Seventy-one of 140 high-risk penetrating keratoplasty patients have already been randomised into the 2 study groups: 39 into the MMF-group and 32 into the control group. All 71 patients received fluocortolon 1mg/kg bw/day, tapered within the first 3 postoperative weeks, and topical prednisolone acetate 5x/day for 5 months. In the MMF-group MMF was administered in a daily dose of 2x1000 mg for the first 6 postoperative months.
Results: Within the follow up of 8,2 ±6,6 months 2 patients of the MMF-group developed reversible endothelial immune reactions after cessation of MMF-application, in contrast to 3 reversible and 3 irreversible immune reactions in the control group. According to Kaplan and Meier 95% of the grafts were free from immune reactions one year postoperatively in the MMF-group, in contrast to only 73% in the control group. This difference, however, was not yet statistically significant (p=0.1; log-rank-test). All side-effects were reversible up to now.
Conclusions: Systemic MMF might turn out to become an effective and safe armament in the prophylaxis of immune reactions after penetrating high-risk keratoplasty.