The Outcomes of Switching from Short- to Long-Term Intravitreal Corticosteroid Implant Therapy in Patients with Diabetic Macular Edema

Abstract

<b><i>Background:</i></b> First-line treatment for diabetic macular edema (DME) is usually with antivascular endothelial growth factor agents, followed by intravitreal corticosteroids as a second-line treatment option. Long-term corticosteroids may offer quality of life and effectiveness benefits over short-term implants. <b><i>Objectives:</i></b> To evaluate outcomes of patients with persistent or recurrent DME who switched from a short-term (dexamethasone) to a long-term (fluocinolone acetonide, FAc) corticosteroid intravitreal implant in a real-world setting. <b><i>Methods:</i></b> This is a retrospective study in 9 Portuguese centers. An FAc intravitreal implant was administered according to product labeling. Effectiveness outcomes were mean change in visual acuity (VA; ETDRS letters), central retinal thickness (CRT; µm), and macular volume (MV; mm<sup>3</sup>). The safety outcome was mean change in intraocular pressure (IOP; mm Hg). All were analyzed at months 1 and 3, and then quarterly until month 24 after implantation. <b><i>Results:</i></b> Forty-four eyes from 36 patients were analyzed. Mean duration of DME was 3.3 ± 1.9 years, and mean follow-up was 8 months. From baseline following FAc implantation, VA increased significantly at months 1 and 6 (mean +6.82 and +13.02 letters, respectively; <i>p</i> = 0.005), and last observation carried forward (LOCF; mean +8.3 letters; <i>p</i> = 0.002). CRT improved significantly at months 1 and 6 (mean –71.81 and –170.77 µm, respectively; <i>p</i> = 0.001), and LOCF (mean –121.46 µm; <i>p</i> = 0.001). MV was consistently, but not significantly, decreased from baseline to LOCF (mean –0.69 mm<sup>3</sup>; <i>p</i> = 0.062). The mean change in IOP was –0.25 and +0.88 mm Hg at months 1 and 6, respectively (<i>p</i> = 0.268), and +1.86 mm Hg at LOCF (<i>p</i> = 0.036). Increases were controlled with topical medication in most cases. <b><i>Conclusions:</i></b> The FAc intravitreal implant is effective in patients previously treated with short-term corticosteroid implants. Thus, after a suboptimal response to antiangiogenics or a short-term corticosteroid, a single FAc implant may be considered an effective and tolerable treatment that can improve long-term outcomes for patients with sight-threatening DME.

Real-World Efficacy and Safety of Fluocinolone Acetonide Implant for Diabetic Macular Edema: A Systematic Review

“…Studies that evaluated the functional efficacy of the FAc implant ( n = 22 studies) had a mean follow-up of 20.0 months (range: 8.5–36.0 months, median: 18.0 months) [ 15 , 26 , 27 , 28 , 29 , 30 , 31 , 32 , 33 , 34 , 35 , 36 , 37 , 38 , 39 , 40 , 41 , 42 , 43 , 44 , 45 ]. Mean baseline BCVA was 50.8 letters (range: 45.7–71.0 letters, median: 51.6 letters) and improved to a maximum of 59.5 letters (range: 49.0–74.8 letters, median: 57.2 letters) after FAc implant injection.…”

“…Of the 22 studies retained, only those assessing both functional and anatomical efficacy were used for this analysis ( n = 18 studies) [ 26 , 27 , 28 , 29 , 30 , 32 , 33 , 34 , 35 , 36 , 37 , 38 , 39 , 40 , 41 , 42 , 43 , 44 , 45 ]. Functional efficacy was defined as a BCVA improvement of at least five letters, while anatomical efficacy as a CRT decrease by 20% or more ( Figure 4 ) similarly to the definitions used by the DRCRnet study group [ 47 , 48 ].…”

“…Of those, lens opacification was observed in 31.47% of cases (range: 0.0–100.0%, median: 21.3%) and 43.2% (range: 0.0–100.0%, median: 33.9%) needed cataract surgery. The mean time between FAc implant injection and cataract surgery was 8.1 months (range: 5.25–13.4 months, median: 6.8 months) [ 34 , 39 , 42 , 44 ].…”

The effects of intravitreal injections on intraocular pressure and retinal nerve fiber layer: a systematic review and meta-analysis

“…Although the literature on alternative corticosteroids is still sparse, some studies have shown that triamcinolone acetonide intravitreal injections result in similar rates of ocular hypertension compared to dexamethasone implant 104,105 . Similarly Vaz-Pereira et al could not find a significant difference in IOP after switching from dexamethasone to fluocinolone acetonide 106 . More research will have to be done in order to be able to more clearly distinguish the pros and cons of the different corticosteroid injections available.…”

<p>Clinical-Decision Criteria to Identify Recurrent Diabetic Macular Edema Patients Suitable for Fluocinolone Acetonide Implant Therapy (ILUVIEN^®) and Follow-Up Considerations/Recommendations</p>

“…38 It has also been previously stated that the FAc implant could be an alternative option for those DME patients that showed insufficient response to either anti-VEGF agents or short-lasting corticosteroids. 80,81 Owing to the insufficient response to previous treatments in Phase IV studies, the FAc implant could also be an option for patients that do not have a complete anatomical response or vision improvement after one injection of dexamethasone implant, as has been demonstrated in real-world practices, 82 because the FAc implant contains a different molecule that could induce a different response.…”