This study will evaluate the use of LX201 to prevent future graft rejection episodes and/or graft failure in patients who have undergone corneal transplantation and who have recently experienced a rejection episode due to an immune response.
LX201 was a novel sustained-release silicone implant containing 30% cyclosporine A by weight. LX201 is intended for surgical episcleral placement in the eye. The study was a Phase 2/3, multi-center, placebo-controlled, randomized, parallel-group, dose-ranging study of LX201 for prevention of corneal allograft rejection or graft failure in subjects who have had one or more rejection episodes following penetrating keratoplasty. After Visit 12 (Week 52), subjects in the USA and India with the implant in the study eye were to be followed for safety at least once per year for a 2 year period or until time of implant removal. In Germany, the implant was to be removed at Week 52 with a 3-month safety follow-up period after removal.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
122
LX201 was a novel sustained-release silicone implant containing 30% cyclosporine A by weight. LX201 was available in two different lengths, 0.50 and 0.75 inch. Each implant is 0.08 inch wide and 0.04 inch in height. The implants are flat on one side (the posterior surface, which is applied to the episclera) and the anterior surface and ends were rounded.
The placebo was a silicone implant 0.75 inch in length. It contained no cyclosporine A
prevention of corneal allograft rejection or graft failure
Time frame: 52 weeks
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Cornea Consultants of Arizona
Phoenix, Arizona, United States
Loma Linda University Health Care
Loma Linda, California, United States
USC Doheny Eye Institute
Los Angeles, California, United States
Bascom Palmer Eye Institute
Miami, Florida, United States
Emory Eye Center
Atlanta, Georgia, United States
University of Illinois at Chicago
Chicago, Illinois, United States
Price Vision Group
Indianapolis, Indiana, United States
The Eye Center at Union Memorial Hospital
Baltimore, Maryland, United States
Wilmer Eye Institute, Cornea Service
Baltimore, Maryland, United States
New England Eye Center
Boston, Massachusetts, United States
...and 20 more locations