Intravitreal fluocinolone acetonide implant for diabetic macular edema – 2-year results from IDEAL, a prospective German observational study

INTRODUCTION: The prospective, observational IDEAL study evaluated the effectiveness and safety of the long-acting fluocinolone acetonide (FAc) implant in patients with chronic diabetic macular edema (DME) and examined the influence of various baseline factors on treatment success. METHODS: Patients with persistent DME despite prior treatment with available therapies who received a FAc implant were included from 35 ophthalmological centers in Germany and monitored for up to 24 months. Demographic and clinical data, including disease duration, previous treatment, best-corrected visual acuity (BCVA), central macular thickness (CMT), intraocular pressure (IOP) and adverse events were recorded at routine visits and analysed descriptively, also in predefined groups. RESULTS: Overall, 214 eyes from 185 patients (57% male) with a mean (SD) age of 66.2 (9.7) years were followed up for a mean (SD) of 21.53 (6.49) months. Functional and anatomical improvements occurred rapidly within one week after FAc injection and were sustained over 24-months in these previously intensively treated eyes (72.9% laser treatment, 79.9% intravitreal therapy with dexamethasone and/or anti-VEGF inhibitors, 28.9% vitrectomy). Mean BCVA increased from 55.8 (18.4) letters at baseline to 60.9 (19.0) letters at 24 months, with comparable results across subgroups defined by baseline characteristics. Eyes with fewer than two prior dexamethasone injections showed a more pronounced CMT reduction. In a subset with early follow-up, greater CMT reduction at week 1 was strongly associated with greater CMT reduction at month 1. Mean IOP in the total cohort increased from 15.3 ± 3.3 mmHg to 17.4 ± 4.8 mmHg within 9 months and returned to 16.7 ± 5.0 by month 24. IOP-lowering was required in 35.5% of eyes (topical medication), and 4.6% underwent IOP-lowering surgery. CONCLUSION: The IDEAL observational study demonstrated a rapid onset of effect and reaffirmed the long-term efficacy and safety of the FAC implant in a large cohort of patients with persistent DME despite extensive prior treatment, thus underlining the high medical need of this treatment option for DME patients insufficiently responding to other therapies.