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A. Sugar, LUCIDA (Lux Corneal Transplant Implant Developmentand Advancement of Therapy) Investigator Group; Design of Phase 2/3 Clinical Trials of a Cyclosporine A Eluting Implant, LX201, for the Prevention and Treatment of Corneal Allograft Rejection or Graft Failure in Patients at High Risk. Invest. Ophthalmol. Vis. Sci. 2008;49(13):1146.
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Despite anecdotal reports of efficacy following the use of topical and systemic Cyclosporin A, there are no therapies approved by the U.S. FDA for prevention of rejection following corneal allograft transplantation. LX201 is a silicone matrix implant that provides sustained release of cyclosporine A locally to the eye over the course of one year. LX201 is implanted episclerally. Two pivotal clinical trials have been designed to evaluate the safety and efficacy of LX201 for the prevention of corneal transplant rejection.
Two international, prospective, parallel-group, dose-ranging, placebo-controlled, randomized multi-center studies comprise the LUCIDA program. Study LX201-01 (LUCIDA Prevention trial) will evaluate 175 patients undergoing penetrating keratoplasty (PK) who are at increased immunological risk for allograft rejection or graft failure. LX201-02 (LUCIDA Treatment trial) will evaluate 270 patients who have recovered from a corneal allograft rejection episode.
The studies are ongoing. The primary endpoint in both protocols is the proportion of subjects experiencing graft rejection or graft failure within 52 weeks following randomization. Secondary endpoints include endothelial cell density, number of quadrants with stromal corneal vascularization, corneal thickness, contrast sensitivity, graft clarity, quality of life, rejection episodes and time to efficacy failure.
Rejection episodes and graft failure due to rejection are a persistent problem for which there are no safe and effective therapies approved. The LUCIDA studies represent the first prospective, randomized and placebo-controlled trials for the prevention and the treatment of corneal allograft rejection and graft failure.
Clinical Trial: :
www.clinicaltrials.gov NCT00447642, NCT00447187
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