Document Detail

Research Title:  FAME Study - Fluocinolone Acetonide for Macular Edema

Sponsor:  Alimera Sciences, Inc.

Investigators:  Jack A. Cohe, M.D., Principal Investigator; Kirk H. Packo, M.D., Pauline T. Merrill, M.D., Mathew W. MacCumber, M.D.

Description:  During the study, patients with diabetic macular edema are randomized to receive 0.5ug/day (projected release period is approximately 18 months), 0.2ug/day (projected release perios is 36 months or sham injection.  1 out of 5 patients will be randomized to sham injection).  The insert is injected via 25-gauge needle and the drug is a corticosteroid that dissolves slowly over the life of the device.  Patients may receive additional macular laser treatments, beginning 6 weeks after treatment.  Patients are eligible for re-treatment after 15 months and will return for follow-up visits throughout the 36 months they are enrolled in the study.

Recruitment:  Open

Project Personnel:  Denise V.

Location(s):  Rush University Medical Center, 1725 West Harrison Street, Chicago, IL  60612