REVIEW  EMERGING ISSUES ON DIABETIC RETINOPATHY AND DIABETIC MACULAR EDEMA 

Minerva Oftalmologica 2018 June;60(2):71-82

DOI: 10.23736/S0026-4903.18.01795-6

Copyright © 2018 EDIZIONI MINERVA MEDICA

lingua: Inglese

0.19 mg fluocinolone acetonide intravitreal implant: place in the management of diabetic macular edema

Anat LOEWENSTEIN ¹ ✉, Usha CHAKRAVARTHY ²

¹ Sidney Fuchs Chair in Ophthalmology, Tel Aviv Medical Center, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel; ² Department of Ophthalmology, Queen’s University of Belfast, Royal Victoria Hospital, Belfast, UK

Diabetic macular edema (DME) is the most common cause of visual impairment in patients with diabetes mellitus. The prevalence of DME is continuously rising worldwide. Epidemiological data indicate that approximately 7% of the diabetes population have DME. Typical first-line therapy for patients with DME is with anti-vascular endothelial growth factor (VEGF) agents (with or without deferred laser treatment); however, a significant proportion of patients have suboptimal response despite repeated anti-VEGF injections, leading to persistent and recurrent edema. The fluocinolone acetonide intravitreal implant is licensed for the treatment of DME. Pooled data from the pivotal FAME trials in patients with DME previously indicated that the fluocinolone acetonide intravitreal implant was more effective than sham injection in improving visual acuity outcomes (best-corrected visual acuity and central retinal thickness). This therapeutic effect was maintained at 36 months. Consistent with corticosteroid class-specific adverse events, cataract formation and elevated intraocular pressure were the most common adverse events with the fluocinolone acetonide intravitreal implant. FAME study results are supported by real-world study findings in patients with persistent DME. This review article summarizes the evidence from the pivotal trials and real-world studies to support the clinical utility of the fluocinolone acetonide intravitreal implant in the DME population.

KEY WORDS: Fluocinolone acetonide - Prostheses and implants - Intravitreal injections - Steroids - Macular edema - Delayed-action preparations