DSMB Supports Continuation of the Phase III Clinical Trial of Iluvien™ for the Treatment of DME
News Sep 29, 2008
Global drug delivery company, pSivida Corp. has announced that after completing its review of safety and efficacy data currently available, an independent Data Safety Monitoring Board (DSMB) has once again recommended that the two pivotal Phase III clinical trials, known collectively as the FAME™ (Fluocinolone Acetonide in Diabetic Macular Edema) Study continue under the current protocol, without change.
The trial is studying the use of Medidur™ FA for the treatment of diabetic macular edema (DME) being conducted by company’s licensing partner, Alimera Sciences. Medidur™ FA will be marketed under the name Iluvien™.
FAME are two, duplicate, double-masked, randomized, multi-center studies following 956 patients in the U.S., Canada, Europe and India for 36 months in support of a planned global registration filing, with safety and efficacy assessed after two years of follow-up. Enrolment for the FAME study was completed in October 2007. All patients have now been followed for at least approximately one year and many have been followed for two or more years.
A DSMB provides an independent evaluation of all trial data to identify potential safety issues that might warrant modification or early termination of ongoing studies. The FAME DSMB, a group comprised of four ophthalmologists and a biostatistician, met to review the Medidur FA Phase III clinical trial data. The DSMB’s charter stipulates that a formal review occur every six months in addition to their ongoing review of the trial.
The cholesterol-lowering drugs called statins have demonstrated substantial benefits in reducing the risk of heart attacks and strokes caused by blood clots (ischemic strokes) in at-risk patients. Since statins are associated with a low risk of side effects, the benefits of taking them outweigh the risks, according to a scientific statement from the American Heart Association that reviewed multiple studies evaluating the safety and potential side effects of these drugs.READ MORE
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