Original articleLong-term Benefit of Sustained-Delivery Fluocinolone Acetonide Vitreous Inserts for Diabetic Macular Edema
Section snippets
Patients and Methods
The Fluocinolone Acetonide for Macular Edema (FAME) studies A and B were performed under a single protocol (C-01-05-001, sponsored by Alimera Sciences, Inc.) as randomized, double-masked, sham injection-controlled, parallel-group, multicenter studies conducted over a 36-month period. The FAME study A was conducted at 49 sites in the United States, Canada, 4 countries in the European Union, and India. The FAME study B was conducted at 52 sites in the United States, India, and 3 countries in the
Baseline Characteristics and Patient Disposition
Treatment groups were balanced with respect to age, race, the mean duration of diabetes (16.1–17.1 years), the mean duration of DME (3.5–3.9 years), the mean BCVA (52.9–54.7 ETDRS visual acuity score), and FTH (451.3–485.1 μm; Table 2). Almost all patients received their assigned treatment (99.5%–100%; Table 2). The percentage of patients that failed to remain in the study until the month 24 primary end point was 19.0% in the high-dose group, 19.9% in the low-dose group, and 22.7% in the sham
Discussion
Diabetic macular edema is a major public health problem. It causes loss of vision in a large number of patients during their working years, resulting in lost productivity and a large expenditure of health care dollars and manpower. After 20 years of diabetes, the prevalence of DME is 28%.1 The high prevalence is compounded by the chronicity of DME, requiring patients and physicians to deal with it for years. Chronic diseases are managed best by treatments that exert a therapeutic effect for a
Acknowledgments
The authors thank the Data Safety Monitoring Board—Frederick L. Ferris III (chair), Stanley Chang, Matthew Davis, Michele Melia, and Richard Parrish—for overseeing the trial.
References (31)
- et al.
The Wisconsin Epidemiologic Study of Diabetic RetinopathyIV. Diabetic macular edema
Ophthalmology
(1984) - et al.
The 14-year incidence of visual loss in a diabetic population
Ophthalmology
(1998) - et al.
Two-year outcomes of the Ranibizumab for Edema of the mAcula in Diabetes (READ-2) Study
Ophthalmology
(2010) - et al.
Corticosteroids inhibit the expression of the vascular endothelial growth factor gene in human vascular smooth muscle cells
Eur J Pharmacol
(1998) - et al.
Triamcinolone attenuates macrophage/microglia accumulation associated with NMDA-induced RGC death and facilitates survival of Muller stem cell grafts
Exp Eye Res
(2010) - et al.
Intraocular injection of crystalline cortisone as adjunctive treatment of diabetic macular edema
Am J Ophthalmol
(2001) - et al.
Fluocinolone acetonide implant (Retisert) for noninfectious posterior uveitis: thirty-four-week results of a multicenter randomized clinical study
Ophthalmology
(2006) - et al.
Fluocinolone acetonide sustained drug delivery device to treat severe uveitis
Ophthalmology
(2000) Photocoagulation for diabetic macular edema: Early Treatment Diabetic Retinopathy Study report number 1
Arch Ophthalmol
(1985)A randomized trial comparing intravitreal triamcinolone acetonide and focal/grid photocoagulation for diabetic macular edema
Ophthalmology
(2008)
Supplemental inspired oxygen improves diabetic macular edema: a pilot study
Invest Ophthalmol Vis Sci
Hypoxia inducible factor-1alpha is increased in ischemic retina: temporal and spatial correlation with VEGF expression
Invest Ophthalmol Vis Sci
Cell type-specific regulation of angiogenic growth factor gene expression and induction of angiogenesis in nonischemic tissue by a constitutively active form of hypoxia-inducible factor 1
Circ Res
Vascular endothelial growth factor is a critical stimulus for diabetic macular edema
Am J Ophthalmol
Primary end point (six months) results of the Ranibizumab for Edema of the mAcula in Diabetes (READ-2) study
Ophthalmology
Cited by (326)
Next generation therapeutics for retinal neurodegenerative diseases
2024, Journal of Controlled ReleaseFrom randomised controlled trials to real-world data: Clinical evidence to guide management of diabetic macular oedema
2023, Progress in Retinal and Eye ResearchManagement of treatment-naïve diabetic macular edema patients: Review of real-world clinical data
2024, European Journal of Ophthalmology
Manuscript no. 2010-1629.
The complete list of the FAME Study Group is available at http://aaojournal.org.
Financial Disclosure(s): The author(s) have made the following disclosure(s):
Peter A. Campochiaro - Consultant - LPath, Inc., Pfizer, Bristol Meyers Squib, and is on the Data and Safety Monitoring Committee for the Regeneron View 1 Trial; Member of Expert Panels - Genentech, Inc., GlaxoSmithKline, for which Johns Hopkins University receives compensation; Financial support - Alimera Sciences, Genentech, GlaxoSmithKline, Genzyme, Molecular Partners
David M. Brown - Consultant - Genentech, Regeneron, Alcon, Allergan, Novartis; Lecturer - Genentech, Alcon; Financial support - Alimera Sciences, Genentech, Regeneron, Alcon, Allergan, Molecular Partners, Novartis
Andrew Pearson - Consultant - Alimera Sciences; Equity owner - pSividia
Thomas Ciulla - Financial support - Regeneron, Genentech, Acuity, Allergan, Macusight
David Boyer - Consultant - Allergan, Alcon, Genentech, Regeneron, Novartis, Pfizer, EyeTech, iCo; Financial support - Allergan, Genentech, Regeneron, Alimera Sciences, iCo, Novartis
Frank G. Holz - Consultant - Novartis, Pfizer, Alimera Sciences; Lecturer - Novartis
Michael Tolentino - Consultant - GlaxoSmithKline, Eyetech, Pfizer, Allergan, Alimera Sciences, OPKO, Promedior, Notal Vision, Acuity Dynamic, Genentech, Ophthotec, Novartis, Regeneron; Lecturer - GlaxoSmithKline, Eytech, Pfizer, Allergan, Alimera Sciences, Novartis, QLT, Genentech, Regeneraon; Financial support - GlaxoSmithKline, Alcon, Eyetech, Pfizer, Allergan, Alimera Sciences, Regeneron, Genentech, Ophthotec, Novartis; Equity owner - OPKO Health, Acuity Dynamics, Cryotooth
John Gonder - Financial support - Eli Lilly, Regerneron, Aventis Pharma, Astra Zeneca, Allergan, Novartis, Alcon, Alimera Sciences
Amod Gupta - Financial support - Alimera Sciences
Lilianne Duarte - Financial support - Alimera Sciences
Steven Madreperla - Financial support - Alimera Sciences
Frances E. Kane - Employee - Alimera Sciences
Barry Kapik - Employee - Alimera Sciences
Kathleen Billman - Employee - Alimera Sciences
Supported by Alimera Sciences, Inc., Atlanta, Georgia, and Psivida, Inc., Watertown, Massachusetts.
- ⁎
Group members listed online (available at http://aaojournal.org).