Switching to intravitreal fluocinolone acetonide implant for refractory diabetic macular edema: 12- and 24-month results

Abstract

Purpose: To report visual and anatomical outcomes of chronic/refractory diabetic macular edema (DME) treated with intravitreal fluocinolone acetonide implant. Setting: Retrospective, one arm, multicentric study. Method: Between 2013 and 2018, 27 consecutive eyes of 25 patients with chronic/refractory DME were treated with a fluocinolone acetonide intravitreal implant. Best registered visual acuity (BRVA), central retinal thickness (CRT), and Goldmann tonometry intraocular pressure (IOP) were assessed at 12 and 24 months. The need for IOP lowering treatment as well as top-up therapy during the follow-up were also assessed. Results: The duration of DME prior to treatment in our study was 54 ± 24 months. The baseline mean BRVA of 0.7 ± 0.34 logMAR improved to 0.5 ± 0.3 ( p = 0.01) at 12 months and 0.46 ± 0.3 ( p = 0.04) at 24 months. At 12 months, BRVA improved in 14 eyes (52%), stabilized in 5 eyes (20%), and decreased in 3 eyes (11%). At 24 months, BRVA improved further in 6 eyes (24%), stabilized in 3 eyes (12%), and decreased in 6 eyes (24 %). Mean CRT decreased from 497 ± 176 to 349 ± 186 μm at 12 months ( p = 0.0005) and to 267 ± 104 μm at 24 months ( p = 0.001). Only five eyes required additional treatment for DME and only three eyes required treatment for raised IOP. Discussion: Our results show that the visual and the anatomical improvements achieved by a single injection of a fluocinolone acetonide implant were maintained up to 24 months with minimal additional therapy even in eyes with a long and heavy history; however, IOP monitoring remains essential.

Anti-VEGF-Resistant Retinal Diseases: A Review of the Latest Treatment Options

“…The 0.59 mg intravitreal FA implant (Retisert; Bausch + Lomb; Rochester, NY, USA) requires surgical implantation but can provided years of therapy, whereas the more recently developed 0.19 mg intravitreal FA implant (Iluvien; Alimera Sciences Inc; Alpharetta, GA, USA) is an injectable implant that can be performed in clinic which can also last for a year or longer. Multiple studies have investigated the intravitreal FA implant in the treatment of anti-VEGF-resistant DME with beneficial, sustained visual acuity and macular thickness results [ 122 , 123 , 124 , 125 , 126 , 127 , 128 ]. Compared to the DEX implant, the 0.19 mg intravitreal FA implant offers continuous steroid therapy for longer treatment intervals (about 4 months compared to 8–24 months).…”

Updates on the Current Treatments for Diabetic Retinopathy and Possibility of Future Oral Therapy

“…Intravitreal fluocinolone acetonide is another implant with longer effective periods than the DEX implant. Multiple studies have shown that the intravitreal fluocinolone acetonide implant could be useful for treating anti-VEGF-resistant DME, with sustained beneficial visual acuity and macular thickness outcomes [128][129][130][131][132]. The systematic review included seven randomized clinical trials that suggested IVTA and surgical implantation of steroids may improve visual outcomes in eyes with refractory DME [133].…”

Retinal changes after fluocinolone acetonide implant (ILUVIEN®) for DME: SD-OCT imaging assessment using ESASO classification

“…Although this incidence of supplemental therapy is not surprising, it does suggest that the sustained reduction in CFT at month 36 might not be entirely due to the implant but could be partly attributable to supplemental therapy. Nevertheless, any such contribution appears to be relatively small as results from other real-life studies with a smaller percentage of eyes receiving supplemental intravitreal therapy for DME after fluocinolone acetonide implantation (0% in a subgroup, 34 19%, 35 and 32% 36 ) still demonstrate sustained reductions in central macular thickness for up to 1, 34 2, 35 and 3 years, 36 respectively.…”