Fluocinolone Acetonide Intravitreal Implant 190 μg (ILUVIEN®) in Vitrectomized versus Nonvitrectomized Eyes for the Treatment of Chronic Diabetic Macular Edema

Abstract

Purpose: To compare the functional and anatomical outcomes after a 0.2 µg/day fluocinolone acetonide (FAc) implant between vitrectomized and nonvitrectomized eyes with chronic diabetic macular edema (DME). Methods: This is a retrospective, comparative analysis of 43 eyes with chronic DME. All eyes were treated with a single 0.2 µg/day FAc implant and followed up for a mean period of 8.5 months (median, 6.0 months; range, 1-21 months). The patients with a 0.2 µg/day FAc implant were divided into 2 groups: 24 eyes which had undergone pars plana vitrectomy prior to 0.2 µg/day FAc (group 1) and 19 eyes which had not been vitrectomized (group 2). Outcome measures included mean changes in best corrected visual acuity (BCVA) in Early Treatment Diabetic Retinopathy Study letters, central subfield foveal thickness (CSFT), and intraocular pressure (IOP), and were measured prior to administration of the 0.2 µg FAc implant, in the first week, at month 1, and quarterly thereafter. Results: Following the 0.2 μg/day FAc implant, the mean change in BCVA at the last observation point, from baseline, was +16.9 ± 3.39 (mean ± SE) letters (p ≤ 0.001) in group 1 and +8.2 ± 4.62 letters (p = 0.092) in group 2. From baseline, a gain of ≥15 letters was achieved in 37.5 and 36.8% of the eyes in group 1 and group 2, respectively. Additionally, an improvement in vision ≥20/40 in 29.2% of group 1 and 15.8% of group 2 was observed. The mean change in CSFT was -217.7 ± 40.8 µm and -155.6 ± 43.4 µm in group 1 and group 2, respectively. The mean change in IOP was +1.6 ± 0.7 mm Hg in group 1 and +0.8 ± 1.3 mm Hg in group 2, relative to baseline. At the last observation point, there were no significant differences between groups 1 and 2 (p > 0.05) in terms of their changes in BCVA, CSFT, and IOP. Conclusion: The results from the real-life practice study demonstrate that the 0.2 μg/day FAc implant is effective and well tolerated in vitrectomized and nonvitrectomized eyes of patients with chronic DME. Our results support the use of a 0.2 μg/day FAc implant to obtain long-term functional and anatomical improvements (mean, 8.5 months; median, 6.0 months) in vitrectomized and nonvitrectomized eyes.

Outcomes in diabetic macular edema switched directly or after a dexamethasone implant to a fluocinolone acetonide intravitreal implant following anti-VEGF treatment

“…Safety signals were consistent with corticosteroid class effects: small elevations in IOP were controlled with IOP-lowering medications when necessary. The rapidity, magnitude and duration of effect of the FAc implant seen in the current study are in line with findings from other real-world studies [19,[27][28][29].…”

“…Hence, this study shows that a single FAc implant delivered long-lasting, significant functional and anatomical vision improvements, regardless of prior dexamethasone treatment, while eliminating the burden of repeated injections: a known barrier to delivering optimal patient care [12]. These findings are in line with previous reports and suggest that FAc may improve the standard and reduce the burden of care for this difficult-to-treat population [19,27,29,30].…”

“…Both the dexamethasone and FAc implants are effective and have tolerable safety profiles for the treatment of DME [11,[18][19][20][21]. However, the FAc implant may offer improved convenience and a reduced clinical burden compared with the dexamethasone implant.…”

<p>Rapid Structural and Functional Improvements with the 0.19 mg Fluocinolone Acetonide Intravitreal Implant for Patients with DME and Low Visual Acuity: 6-Month Data from the UAE</p>

“…Both dexamethasone (OZURDEX ® 700 µg; Allergan Ltd, Marlow, Buckinghamshire, UK) and FAc implant (ILUVIEN ® 190 µg; Alimera Sciences Inc., Atlanta, GA, USA) are licensed in Europe and the USA for the treatment of DME that persists or recurs despite treatment. 14,15 Both implants are effective in the treatment of DME, 10,[16][17][18] with the FAc implant offering improved convenience and a reduced clinical burden compared with the dexamethasone due to the longer duration of action of a single intravitreal injection. While the latter is short-acting (its effects lasting for around 6 months before re-injection is required), the FAc implant is designed to deliver inflammationsuppressing FAc over a period of up to 3 years, with a daily release rate of 0.2 µg.…”

<p>The Evolving Treatment of Diabetic Retinopathy</p>

“…134,135 The availability of corticosteroids in the form of sustained release implants has potential benefits in terms of durability of therapy in vitrectomized eyes. 136 Results from protocol U from the DRCR Network demonstrated that in the short term, combination intraocular steroid in the form of a dexamethasone implant plus anti-VEGF therapy (ranibizumab) in comparison with that of continued anti-VEGF therapy alone in eyes with persistent center-involved DME and VA impairment despite previous anti-VEGF treatment, had modest improvement in visual gain despite significant reductions in retinal thickness on OCT. 137 In phakic eyes receiving continuous anti-VEGF therapy for DME, the addition of intravitreous corticosteroids did not result in significant visual improvements. 138,139 Recent reports summarizing observational studies investigating dexamethasone implants in DME have reported similar final VA outcomes when compared to anti-VEGF monotherapy, but superior visual gains in real-life practice.…”