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Enrollment complete for phase 3 trial of drug delivery insert for diabetic macular edema

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ATLANTA — Enrollment in the phase 3 Fluocinolone Acetonide in Diabetic Macular Edema clinical trial evaluating the Medidur FA drug delivery implant has been completed, according to a press release from Alimera Sciences and pSivida Limited, joint developers of the device.

The FAME trial is a double-masked, randomized, multicenter study involving more than 900 patients in the United States, Canada, Europe and India. Patients will be followed for 36 months, with safety and efficacy assessed at 2 years, according to the release.

The study is evaluating the efficacy of the Medidur implant for delivering fluocinolone acetonide to the retina for up to 3 years for treating diabetic macular edema. The device is injected into the vitreous using a proprietary 25-guage injector system during a minimally invasive procedure, the release said.