BACKGROUND AND OBJECTIVE: To evaluate glaucomatous changes in patients with diabetic macular edema (DME) treated with intravitreal implants releasing 0.2 ?g/day or 0.5 ?g/day fluocinolone acetonide (FAc) (Iluvien 0.2 ?g/day; Alimera Sciences, Alpharetta, GA) or sham control. PATIENTS AND METHODS: Fundus photographs were assessed to determine clinically significant changes in glaucomatous indicators. RESULTS: The mean cup-to-disc ratio (CDR) change was similar with all three treatments. Compared with sham control, a significantly greater proportion of patients treated with 0.5 ?g/day but not 0.2 ?g/day FAc experienced a CDR increase of greater than 0.1. There was no significant increase in the proportion of patients experiencing a CDR increase of greater than 0.2 with either dose of implant versus sham control. Other indicators of glaucomatous change did not differ significantly with treatment. Subgroup analyses showed no differences in cupping based on ocular or baseline characteristics. CONCLUSION: Treatment with FAc for 36 months was not associated with significant glaucomatous optic nerve head changes in patients with DME with or without increased intraocular pressure.
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