Fluocinolone acetonide for the treatment of chronic diabetic macular edema: an Italian real‐world experience

Abstract

AbstractPurposeThis is a retrospective real‐world study on the use of Fluocinolone acetonide (FAc) intravitreal implant (Iluvien®) for the treatment of chronic diabetic macular edema (DME) insufficiently responsive to available therapies. Its aim is to give a further contribution in assessment of efficacy and safety of this drug delivery system.MethodsPatients included were collected from July 2017 to May 2019. 53 pseudophakic chronic DME patients (69 eyes) were enrolled to evaluate anatomo‐functional outcomes; namely, best corrected visual acuity (BCVA), central macular thickness (CMT) and complications (i.e. rise in intraocular pressure (IOP) and need for IOP lowering medications, hemovitreous, endophtalmitis) of Iluvien® implants. The study partecipants were all previously unsuccessfully treated with first‐line therapies (anti‐VEGF and laser) and intravitreal dexamethasone (Ozurdex®). Patients were considered eligible only in presence of response to the latter drug without significant intra‐ocular pressure increase. Information about further need for DME additional therapies post‐FAc were also recorded. The data of 18 eyes with at least 12 months follow‐up are reported.ResultsAt baseline the mean overall BCVA was 58.3±17.5 ETDRS scale letters. Post‐FAc implant, mean BCVA rised to 63.9 ± 15.2, 60.8 ± 18.3, 61.3 ± 16.9 and 64.5 ± 13.9 ETDRS letters at 2, 4, 6 and 12 months respectively. The percentage of eyes achieving 15 or more ETDRS letters improvement within 12 months was 33.3%. CMT values, from a baseline mean of 517.4 ± 204.0 µm, decreased to 364.9 ± 138.4 µm, 410.8 ± 192.4 µm, 339.0 ± 126.8 µm and 339.9 ± 82.0 at 2, 4, 6 and 12 months, respectively. In this period of observation a dry macula (<300 µm) was obtained in 33.3% of eyes. Recorded complications included increase in IOP with need for IOP lowering medications in 18.9% of study population. Only 8.7% patients needed to perform additional DME therapies for poor response to FAc.ConclusionsThe preliminary results of our study support the use of FAc for the treatment of chronic DME. Efficacy and safety profiles seem to be comparable with the ones of the FAME pivotal study but with less IOP concerns. Selecting patients previously treated with intravitreal steroids and without increase in IOP can further minimize risks. Mean increase of IOP over time can be safely managed with topical therapy in the large majority of cases.