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Haifa A Madi, Yanmei Chen, David Steel, Jonathan Smith, Teresa Sandinha, Maged S Habib; Real world data on the efficacy of Fluocinolone Acetonide (ILUVIEN) in eyes with diabetic macular oedema. Invest. Ophthalmol. Vis. Sci. 2018;59(9):4817.
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© ARVO (1962-2015); The Authors (2016-present)
To report real-world data on visual and anatomical outcomes in eyes treated with 0.2 μg/day Fluocinolone Acetonide (FAc) for diabetic macular oedema (DMO) in a single tertiary referral centre in the UK.
Medical records of patients with DMO treated with FAc implant were reviewed. Main outcome measures were changes in best-corrected visual acuity (BCVA) and central macular thickness (CMT). Other outcome measures included history of prior intravitreal therapy, prior pars plana vitrectomy (PPV) and intraocular pressure (IOP) related adverse events.
We identified 45 eyes in total, 42 completed 12 months and 34 completed 24 months of follow-up. Mean (SD) age was 66 (11.9) years, 58% were female. Prior intravitreal therapies included anti-VEGF (mean 5.4 injections) and steroids (mean 0.1 injections).Mean BCVA improved from 50 letters at baseline to 52 letters at 6 months, 54.7 at 12 months and 54.4 letters at 24 months. The percentage of patients that gained ≥15 letters from baseline at 6, 12 and 24 months was 15%, 14%, and 21% respectively.The CMT improved from 478.2μm at baseline by 120.5μm, 97.4μm, and 85.9μm at 6, 12 and 24 months, respectively.The percentage of patients required IOP-lowering drops at 6, 12 and 24 months was 7%, 12%, and 6% respectively. Overall, 6% of patients required glaucoma surgery.A sub-group analysis demonstrated that the primary indication for PPV was proliferative diabetic retinopathy, followed by abnormalities of the vitreoretinal interface and aqueous misdirection. The implant was injected after a mean of 22.7 months after PPV. The mean change in BCVA from baseline was +6.5 letters at 12 months and +11.7 at 24 months. The percentage of patients that gained ≥15 letters from baseline at 12 and 24 months was 26% and 39% respectively. The mean improvement in CMT from baseline at 12 and 24 months was 110.1μm and 110.8μm, respectively.
Our real-world data is consistent with clinical trial results, and indicates that eyes treated with FAc in routine clinical practice can achieve similar improvements in visual and anatomical outcomes as those reported in the Fluocinolone Aceotnide for Macular Edema (FAME) studies with minimal IOP related adverse effects. Furthermore, our data also suggests that FAc implants represent an efficacious treatment option for persistent DMO in vitrectomised eyes with an acceptable safety profile.
This is an abstract that was submitted for the 2018 ARVO Annual Meeting, held in Honolulu, Hawaii, April 29 - May 3, 2018.
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