Long-term efficacy and safety of intravitreal dexamethasone implant for the treatment of diabetic macular edema.

PURPOSE: To evaluate the long-term efficacy and safety of the dexamethasone intravitreal implant Ozurdex® in the treatment of diabetic macular edema (DME).

METHODS: This was a retrospective noncomparative study. A total of 23 patients with DME followed for at least 12 months were included. All patients were treated with at least 2 Ozurdex® injections for the treatment of DME. Best-corrected visual acuity, central retinal thickness, intraocular pressure (IOP), and cataract progression were recorded over 12 months.

RESULTS: From baseline, the mean decrease in central retinal thickness was 315.9 µm at the 12th month and the mean best-corrected visual acuity improvement from baseline was 8.7 letters. Ozurdex® is administered via the extended release system Novadur®. Its efficacy extends beyond 4 months with a single injection and permits allows good stabilization until the 12th month, with 2.13 injections during this period. An increase in IOP was observed in 13.1% of patients and all were managed using topical IOP-lowering medications. No glaucoma or cataract surgery was necessary, and no endophthalmitis was reported.

CONCLUSIONS: In real-life clinical practice, Ozurdex® has anatomical and functional effectiveness for the treatment of DME. Side effects were rare and manageable in our practice.