Abstract

DO.10.04

Prevention of immune reactions after keratoplasty by means of an episclerally pla-ced Cyclosporine-A-eluting silicone matrix: the LUCIDA trials

Daniel Böhringer1, Johannes Schwartzkopff1, K. Huber2, Antonia M. Joussen2, Berthold Seitz3, Chris P. Lohmann4, Elisabeth M. Messmer5, Claus Cursiefen6, Friedrich E. Kruse6, Gerd Geerling7, Daniel Meller8, Bernhard Nölle9, Thomas Reinhard10
1Universitäts-Augenklinik Freiburg; 2Universitäts-Augenklinik Düsseldorf;
3Universitäts-Augenklinik Homburg-Saar; 4Universitäts-Augenklinik München, Klinikum Rechts der Isar; 5Universitäts-Augenklinik München, LMU; 6Universitäts-Augenklinik Erlangen; 7Universitäts-Augenklinik Würzburg; 8Universitäts-Augenklinik Essen; 9Universitäts-Augenklinik Kiel;.Und die internationale LUCIDA Studiengruppe; 10Universitäts-Augenklinik Freiburg

Objective: Preclinical as well as clinical data points towards a protective effect of Cyclosporin A (CsA) on graft rejections following keratoplasty. The LUCIDA (LUx Corneal Transplant Implant Development and Advancement of Therapy) trials consist of two global, prospective, parallel-group, dose-ranging, placebo-controlled, randomized multicenter studies. Both trials aim at demonstrating efficacy and safety of a silicone matrix implant reservoir of CsA for preventing immune reactions in high-risk keratoplasty.
Results: We present the preclinical data, the trial design and the demographic data of the included patients. Database lock is sheduled at 2010. FDA approval ("fast track-mode") is aimed for 2011.
Conclusions: LUCIDA comprise of two randomized placebo-controlled trials on prophylaxis of corneal allograft rejection. The LX201 implant establishes the possibility of sparing steroids in the aftercare in corneal transplantation. Furthermore, the common problem of malcompliance could be elegantly solved by this approach.

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