Original articleSustained Delivery Fluocinolone Acetonide Vitreous Inserts Provide Benefit for at Least 3 Years in Patients with Diabetic Macular Edema
Section snippets
Methods
The FAME A and B studies were performed under a single protocol as randomized, double-masked, sham injection-controlled, parallel-group, multicenter studies conducted over a 36-month period. The first, FAME A, was conducted at 49 sites in the United States, Canada, 4 countries in the European Union, and India; FAME B was conducted at 52 sites in the United States, India, and 3 countries in the European Union. The studies adhered to the guidelines of the Declaration of Helsinki and the protocol
Baseline Characteristics and Patient Disposition
There were no imbalances at baseline with respect to age, race, the mean duration of diabetes (range, 16.1–17.1 years), the mean duration of DME (range, 3.5–3.9 years), mean BCVA (range, 52.9–54.7 ETDRS visual acuity score), or FTH (range, 451.3–485.1 μm). The percentage of patients who failed to remain in the study until the month 24 primary endpoint was 19.0% in the high-dose group, 19.9% in the low-dose group, and 22.7% in the sham group, and the percentage that exited before the month 36
Discussion
The primary outcome was met in both FAME trials. The integrated dataset showed that 28% of patients treated with a low- or high-dose FAc insert had an improvement of ≥15 in BCVA letter score at month 24 compared with 16% in the sham injection group. Continued follow-up has shown that those excellent results are maintained through at least 3 years, with roughly 28% of patients in the FAc insert groups still showing improvement of ≥15 in BCVA letter score. Approximately 30% of patients in each of
Acknowledgments
The study was supported by Alimera Sciences, Atlanta, Georgia. The authors thank the Data and Safety Monitoring Board: Frederick L. Ferris, III (Chairman), Stanley Chang, Matthew Davis, Michele Melia, and Richard Parrish for overseeing the trial.
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Cited by (0)
Manuscript no. 2012-67.
Financial Disclosure(s): The authors have made the following disclosures:
Clare Bailey: Travel grant — Novartis UK.
Kathleen Billman: Employee — Stock options, Alimera Sciences.
David Boyer: Consultant — Alimera Sciences; consultant, lecture fees — Genentech; Consultant — Regeneron.
David Brown: Consultant — Alimera Sciences, Allergan, Alcon, Eli Lilly, Novartis, Regeneron.
Peter Campochiaro: Data and safety monitoring committee — Regeneron; consultant — Allergan and LPath.
Sanford Chen: Consultant, travel support — Alimera Sciences; consultant — Genentech, Regeneron, Allergan, Alcon, EyeTech; lecture fees — Genentech, Alcon; travel support — Genentech, Regeneron.
Bruce Garretson: Travel support — Alimera Sciences.
Kenneth Green: Employee, stock options — Alimera Sciences.
Seenu Hariprased: Advisory board — Scimedica; consultant — Alcon, Allergan, Genentech, Regeneron, Ocular Therapeudix, Bayer, Optos, OD-OS; lecture feed — Alcon, Allergan, Genentech; stock options — OD-OS, Ocular Therapeudix. Employee, stock options — Alimera Sciences.
Frances Kane: Employee, stock options — Alimera Sciences
Barry Kapik: Employee, stock options — Alimera Sciences.
Andrew Pearson: Consultant — Alimera Sciences; stock options — pSividia.
Jose Ruiz-Moreno: Advisory board — Bayer, Allergan, Novartis.
Gisele Soubrane: Travel support — Alimera Sciences; advisory board — Allergan, Novartis; consultant — Thea; lecture fees — Allergan.
Supported by Alimera Sciences Inc.
*The complete list of FAME Study Group is available at http://aaojournal.org.
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Group members listed online (available at http://aaojournal.org).