Evaluation of 0.2 µg/day fluocinolone acetonide (ILUVIEN) implant in a cohort of previously treated patients with diabetic macular oedema (DMO): a 36-month follow-up clinical case series.

Objective: To assess the real-world effectiveness and safety of single injection of a fluocinolone acetonide (FAc) implant in previously treated patients with recurrent diabetic macular oedema (DMO) over a 36-month follow-up period.

Methods And Analysis: This is a retrospective study conducted at a single ophthalmology department at the Royal Hallamshire Hospital, Sheffield, UK. Data were collected using electronic medical records to identify all patients treated with a FAc implant for DMO between March 2014 and November 2014, followed with a 36-month clinic follow-up. Outcomes measured included mean change in best-recorded visual acuity (BRVA) and central macular thickness (CMT) over the period of 36 months, treatment burden pre-implant and post-implant, and functional and anatomical responder rates.

Results: Twenty-six eyes (n=22 patients) were treated with single intravitreal FAc implant followed with 36 months of follow-up. At 24 and 36 months, 86.4% and 75.0% of patients maintained or gained vision post-FAc implant in routine clinical practice. The mean BRVA increased from 41.8 to 54.6 letters at month 24 and 45.8 letters at month 36, with 50.0% and 33.3% of patients achieving a ≥15 letter improvement at months 24 and 36, respectively. The mean CMT reduced from 600.8 µm at baseline to 351.0 µm and 392.5 µm at months 24 and 36, respectively. Overall, a mean of one treatment every 13.33 months post-FAc implant (vs 3.24 months pre-FAc implant) was reported. Eleven eyes had an increased intraocular pressure of ≥10 mm Hg and 12 eyes had an increase to ≥25 mm Hg from baseline.

Conclusion: These results further support the effectiveness and safety of FAc implant in previously treated patients with persistent or recurrent DMO in a real-world clinical practice.