What have we learned from a decade treating patients with diabetic macular oedema with 0.19 mg fluocinolone acetonide intravitreal implant?

Abstract

Diabetic macular oedema [DMO] is a prevalent and sight-threatening condition among diabetic patients, which can cause irreversible blindness. Since angiogenesis and inflammation are two key elements in the etiopathogenesis of DMO, intravitreal injections of vascular endothelial growth factor inhibitors [anti-VEGF] and sustained released intravitreal corticosteroid implants are currently considered as treatments of choice. The introduction, 10 years ago, of the 0.19 mg fluocinolone acetonide [FAc] implant for treating eyes with vision impairment associated with recurrent and persistent DMO represented an important advance. Since then, two randomized-control trials and many real-world studies have shown its good efficacy/safety profile and the replicability of its treatment regimen. The FAc implant is, in general terms well tolerated, although it is associated with intraocular pressure-[IOP] and cataract-related adverse events [AEs]. Most IOP-related AEs are effectively controlled with ocular-hypotensive therapies. The objective of this paper is to review the role of FAc implant in the treatment of DMO over the 10 years since its launch, as well as its impact on clinical practice outcomes.

Fig. 1. Overview of the mean visual acuity at baseline and the last follow-up visit in different real-world studies.

Adapted from Augustin et al. [28]; Mushtaq et al. [32]; Bailey et al. [33]; Mathis et al. [35]; Khoramnia et al. [39]; Singer et al. [36]; Ruiz-Moreno et al. [42]; Capone et al. [46]; and Teixeira et al. [48]. Studies: IRIS [39]; Midlands [32]; PALADIN [36]; Medisoft [33]; Retro-IDEAL [28]; RealFac [35]; ICE-IT [46]; RIVER [48]; REACT [42]. BCVA: Best corrected visual acuity; ETDRS: Early Treatment Diabetic Retinopathy Study.

Fig. 2. Overview of the mean central macular thickness at baseline and the last follow-up visit in different real-world studies.

Adapted from Augustin et al. [28]; Mushtaq et al. [32]; Bailey et al. [33]; Mathis et al. [35]; Singer et al. [36]; Ruiz-Moreno et al. [42]; Capone et al. [46]; and Teixeira et al. [48]. Studies: Midlands [32]; PALADIN [36]; Medisoft [33]; Retro-IDEAL [28]; RealFac [35]; ICE-IT[46]; RIVER [48]; REACT [42]. CMT: Central macular thickness.

Fig. 3. Overview of the mean intraocular pressure (IOP) at baseline and the last follow-up visit in different real-world studies.

Adapted from Augustin et al. [28]; Mushtaq et al. [32]; Bailey et al. [33]; Mathis et al. [35]; Singer et al. [36]; Ruiz-Moreno et al. [42]; Capone et al. [46]; and Teixeira et al. [48]. Studies: Midlands [32]; PALADIN [36]; Medisoft [33]; Retro-IDEAL [28]; RealFac [35]; ICE-IT[46]; RIVER [48]; REACT [42]. IOP: Intraocular pressure.