1Reinhard T., 1Reis A., 1Mayweg S., 2Mathis G., 1Sundmacher R.

1Eye Hospital Heinrich Heine University Düsseldorf; 2SUCAMPO-Pharma, Schweiz

Background: Patients following allogeneic keratoplasty are treated with topical and frequently with systemic steroids to prevent immune reactions. Steroids are known to yield good results, but exert a wide range of side effects. The efficacy of topial FK506 in preventing immune reactions has already been demonstrated experimentally. FK506, an IL-2-inhibitor like Cyclosporin A (CSA), is known to be approximately 100 fold more potent than CSA.
Aim of the study: In this study the efficacy and safety of topical FK506 will be compared to our standard treatment (i.e. steroids) after penetrating normal-risk keratoplasty.
Patients and methods: 40 normal-risk-keratoplasty patients will be included. All of the patients will be treated with systemic fluocortolon 1mg/kg bw/day tapered off within the first 3 weeks postoperatively. Twenty of them will be treated with topical FK506 (0,06%) 3 times per day for 6 months. The control group (n=20) will be treated with topical prednisolone acetate 5 times per day and tapered off within 6 months. Drug efficacy and safety will be assessed by incidence of graft failures/immune reactions and adverse side effects.
Progress of study: 22 patients have been randomized since November 2000. Within a mean follow-up of 2 (0-6) months no irreversible graft failure or immune reaction have been observed. These data indicate that topical FK506 is a promising new immunosuppressive agent which might support our therapeutic armanentarium following allogeneic keratoplasty.

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