Abstract
PURPOSE: To evaluate the efficacy and safety of sustained-delivery fluocinolone acetonide (FAc) intravitreal implant for diabetic macular edema (DME). PATIENTS AND METHODS: Prospective study in patients with DME insufficiently responsive to laser and anti-vascular endothelial growth factor (anti-VEGF). Patients with history of rise of intraocular pressure after intravitreal corticosteroids were excluded. RESULTS: The macular edema rapidly decreased both in group 1 (prior laser only; n=7 eyes) and group 2 (prior laser and ≥3 monthly anti-VEGF therapy; n=10 eyes) and central subfield thickness was reduced by -299 μm (P=0.008) and -251 μm (P=0.016) at 12 months, respectively. Mean area under the curve from baseline to last value for pseudophakic eyes was +4.2 letters in group 1 and +9.5 letters in group 2. Overall, the FAc implant was well tolerated. CONCLUSION: This prospective study confirms the efficacy of the FAc implant in DME patients insufficiently responsive to laser and anti-VEGF. Moreover, with a careful patient selection, our safety results would support an earlier use of FAc in the DME treatment pathway.