Continuation of study urged for diabetic macular edema insert
After completing its review of safety and efficacy data currently available, an independent data safety monitoring board once again has recommended that two pivotal phase III clinical trials, known collectively as the Fluocinolone Acetonide in Diabetic Macular Edema Study, continue under the current protocol, without change.
Alpharetta, GA-After completing its review of safety and efficacy data currently available, an independent data safety monitoring board once again has recommended that two pivotal phase III clinical trials, known collectively as the Fluocinolone Acetonide in Diabetic Macular Edema (FAME) Study, continue under the current protocol, without change. This news is according to a prepared statement issued by Alimera Sciences, which has a majority stake in the development of the proprietary intravitreal insert with fluocinolone acetonide (Medidur FA) being investigated in the trial as a treatment for diabetic macular edema (DME).
The two, duplicate, double-masked, randomized, multicenter trials of the study are following 956 patients in the United States, Canada, Europe, and India for 36 months in support of a planned global registration filing, with safety and efficacy assessed after 2 years of follow-up. Enrollment was completed in October.
"As of this latest [board] review, we continue to be on track for regulatory submissions in early 2010," said Dan Myers, Alimera's chief executive officer.
The FAME board, a group of four ophthalmologists and a biostatistician, reviewed the phase III clinical trial data. The monitoring board's charter stipulates that it perform a formal review every 6 months in addition to conducting the group's ongoing review of the trial.
