Elsevier

Ophthalmology

Volume 121, Issue 10, October 2014, Pages 1892-1903.e3
Ophthalmology

Original article
Sustained Delivery Fluocinolone Acetonide Vitreous Implants: Long-Term Benefit in Patients with Chronic Diabetic Macular Edema

Presented in part at: EURETINA Annual Meeting, September 2012, Milan, Italy; and American Society of Retina Specialists Annual Meeting, August 2012, Las Vegas, Nevada.
https://doi.org/10.1016/j.ophtha.2014.04.019Get rights and content
Under a Creative Commons license
open access

Purpose

To present the safety and efficacy of intravitreal implants releasing 0.2 μg/day fluocinolone acetonide (FAc) in patients with chronic versus nonchronic diabetic macular edema (DME). To assess ocular characteristics, anatomic changes, and re-treatment and ancillary therapies that may explain the differential treatment effect seen with intravitreal implants releasing FAc 0.2 μg/day in patients with chronic and nonchronic DME. An overall benefit-to-risk assessment for the FAc 0.2-μg/day and FAc 0.5-μg/day doses has been reported previously.

Design

Preplanned subgroup analysis of chronic (duration of diagnosis, ≥3 years) and nonchronic (duration of diagnosis, <3 years) DME in patients from 2 randomized, sham injection-controlled, double-masked, multicenter clinical trials.

Participants

Patients with persistent DME despite 1 or more macular laser treatment were randomized 1:2:2 to sham injection (n = 185), FAc 0.2 μg/day (n = 375), or FAc 0.5 μg/day (n = 393).

Methods

Patients received study drug or sham injection and after 6 weeks were eligible for rescue laser. Based on re-treatment criteria, additional masked study drug could be given after 1 year.

Main Outcome Measures

Percentage of patients with improvement of 15 letters or more from baseline. Secondary outcomes included other parameters of visual function and foveal thickness.

Results

At month 36, the difference between FAc 0.2 μg/day and sham control in the percentage of patients who gained 15 letters or more was significantly greater in chronic DME patients (FAc 0.2 μg/day, 34.0% vs. sham, 13.4%; P<0.001), compared with patients with nonchronic DME (FAc 0.2 μg/day, 22.3% vs. sham, 27.8%; P = 0.275). The greater response in patients with chronic DME was not associated with baseline ocular characteristics, changes in anatomic features, or differences in re-treatment or ancillary therapies. The ocular adverse event profile for FAc 0.2 μg/day was similar regardless of DME duration.

Conclusions

This is the first published analysis correlating duration of diagnosis of DME with treatment effect. In patients with chronic DME, FAc 0.2 μg/day provides substantial visual benefit for up to 3 years and would provide an option for patients who do not respond to other therapy.

Abbreviations and Acronyms

BCVA
best-corrected visual acuity
CPT
center point thickness
DME
diabetic macular edema
ETDRS
Early Treatment Diabetic Retinopathy Study
FAc
fluocinolone acetonide
FAME
Fluocinolone Acetonide for Diabetic Macular Edema
IOP
intraocular pressure
VEGF
vascular endothelial growth factor

Cited by (0)

Supplemental material is available at www.aaojournal.org.

Financial Disclosure(s): The author(s) have made the following disclosure(s):

José Cunha-Vaz: Consultant and Study investigator – Alimera Sciences, Bayer, Fovea Pharmaceuticals, Gene Signal, Novartis, OM Pharma, Pfizer, Roche, ThromboGenics, Zeiss

Paul Ashton: Employee – Alimera Sciences; Patent – Alimera Sciences; Royalties – pSivida

Raymond Iezzi: Advisory Board, Equity owner, Financial support – Alimera Sciences; Patent – Dendrimers for Sustained Release of Compounds

Peter Campochiaro: Financial support – Alimera Sciences, Allergan, Aerpio Therapeutics, Genzyme, GlaxoSmithKline, Oxford Biomedica, Genentech; Consultant – Advanced Cell Technology, Aerpio Therapeutics (paid to institution), Applied Genetic Technologies, Gene Signal, Regeneron (paid to institution), Genentech (paid to institution)

Frank G. Holz: Financial support (paid to institution) – Alimera Sciences, Novartis, Bayer Healthcare, GSK, Alcon, Optos, Heidelberg Engineering, Carl Zeiss Meditec; Consultant – Alimera Sciences; Bayer Healthcare, Heidelberg Engineering, Novartis, Pfizer, Acucela, Genentech, Alcon, Allergan; Financial support (for travel) – Alimera Sciences; Lecturer – Alcon, Pfizer, Novartis, Heidelberg Engineering, Bayer Healthcare

Ronald P. Danis: Financial support (paid to institution) – Alimera Sciences

Baruch D. Kuppermann: Investigator and Consultant – Alimera Sciences, Allergan, Genentech, GSK, Pfizer, Regeneron, ThromboGenics; Consultant – Alcon, Allegro, Ampio, Glaukos, Neurotech, Novagali, Novartis, Ophthitech, Santen, SecondSight, Teva

Kathleen Billman: Financial support (for travel), Employee, Equity owner – Alimera Sciences

Barry Kapik: Financial support (for travel), Employee, Equity owner – Alimera Sciences

Frances Kane: Financial support (for travel), Employee, Equity owner – Alimera Sciences

Ken Green: Financial support (for travel), Employee, Equity owner – Alimera Sciences

Supported by Alimera Sciences, Inc, Alpharetta, Georgia. The sponsor participated in the design of the study, conducting the study, data collection, data management, data analysis, interpretation of the data, preparation of the manuscript, and review of the manuscript.

Members of the FAME Study Group are listed in Campochiaro PA, Brown DM, Pearson A, et al. Ophthalmology 2011;118:626–35.e2.