Real-world experience with 0.2 μg/day fluocinolone acetonide intravitreal implant (ILUVIEN) in the United Kingdom

Abstract

AimsTo compare safety outcomes and visual function data acquired in the real-world setting with FAME study results in eyes treated with 0.2 μg/day fluocinolone acetonide (FAc).MethodsFourteen UK clinical sites contributed to pseudoanonymised data collected using the same electronic medical record system. Data pertaining to eyes treated with FAc implant for diabetic macular oedema (DMO) was extracted. Intraocular pressure (IOP)-related adverse events were defined as use of IOP-lowering medication, any rise in IOP>30 mm Hg, or glaucoma surgery. Other measured outcomes included visual acuity, central subfield thickness (CSFT) changes and use of concomitant medications.ResultsIn total, 345 eyes had a mean follow-up of 428 days. Overall, 13.9% of patients required IOP-lowering drops (included initiation, addition and switching of current drops), 7.2% had IOP elevation >30 mm Hg and 0.3% required glaucoma surgery. In patients with prior steroid exposure and no prior IOP-related event, there were no new IOP-related events. In patients without prior steroid use and without prior IOP-related events, 10.3% of eyes required IOP-lowering medication and 4.3% exhibited IOP >30 mm Hg at some point during follow-up. At 24 months, mean best-recorded visual acuity increased from 51.9 to 57.2 letters and 20.8% achieved ≥15-letter improvement. Mean CSFT reduced from 451.2 to 355.5 μm.ConclusionsWhile overall IOP-related emergent events were observed in similar frequency to FAME, no adverse events were seen in the subgroup with prior steroid exposure and no prior IOP events. Efficacy findings confirm that the FAc implant is a useful treatment option for chronic DMO.

An overview of the clinical outcomes of the fluocinolone acetonide 190 µg intravitreal implant clinical evidence study in the United Kingdom (ICE-UK)

“…Clearly, when treated with FAc implants, patients with chronic DME and poor vision benefited, an important point to take into consideration when treatment is rolled out to those who are yet to gain vision using the "classical" treatment modalities 8,12 . Those with the poorest visual acuity did well in the clinical setting, providing the clinician with an additional potential therapeutic option where none existed previously.…”

Evaluation of the clinical effectiveness of fluocinolone acetonide 190 µg intravitreal implant in diabetic macular edema: a comparison between study and fellow eyes

“…In an electronic medical record based study across 14 UK clinical sites mean best recorded visual acuity improved from 51.9 letters at baseline (n ¼ 311), to 55.5 at 12 months (n ¼ 160) and 57.2 at 24 months (n ¼ 53) 24 . In a retrospective study carried out by Elaraoud and colleagues, an improvement in visual acuity and CFT was observed in 15 out of 22 eyes treated with FAc intravitreal implant 25 .…”

Rezidivierendes diabetisches Makulaödem: Was tun?

“…Insbesondere beobachteten wir in diesem Fall, dass eine vorherige Steroidresponse nach intravitrealer Gabe von Triamcinolon ein prädiktiver Faktor für das Ansprechen auf das FAc-Implantat, einschließlich der AID-Outcomes der Patienten, war. Bereits vor Kurzem konnten Bailey et al [18] zeigen, dass die notfallmäßige Anwendung von AID-senkenden Medikamenten oder ein AID-Anstieg über 30 mmHg nach einer Behandlung mit FAc häufiger bei Patienten berichtet wurde, bei denen in der Vorgeschichte AID-bezogene Ereignisse aufgetreten waren. In unserem Fall wurde die okulare Hypertension erfolgreich mittels SLT behandelt, was für eine mögliche Bedeutung der SLT als wenig invasive therapeutische Option für das Management von AID-Erhöhungen im Zusammenhang mit der FAc-Behandlung spricht.…”