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Ozurdex limits number of treatments needed in real-life DME
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Ozurdex was found to be safe and effective for the treatment of diabetic macular edema in a real-life, prospective study.
The study included 54 eyes of 54 patients with DME refractory to previous treatment with anti-VEGFs. Ozurdex (dexamethasone intravitreal implant, Allergan) was injected under a sterile protocol, and re-injection was performed at 6 months in case of recurrent DME with decreased vision and/or increased central subfield thickness.
At the end of the 12-month follow-up, 31 patients (57.4%) had total resolution of macular edema. A mean improvement of 5.2 letters was reported. Twenty-nine patients (53.7%) had an improvement in best corrected visual acuity of five letters or more, with 14.8% gaining 15 letters or more; 33.3% were stable and 13% lost vision. Central subfield thickness decreased significantly, with a maximum decrease at 1 month.
No severe systemic side effects were reported. Two out of 14 phakic patients (14.3%) developed cataract. IOP increased slightly but not significantly at 1 month and was followed by a progressive decrease. The mean number of injections was 2.1.
The presence of microstructural changes in the retina due to recurrent edema, such as intraretinal changes, hyperreflective foci and hard exudates, was correlated with unfavorable visual results. Phakic eyes also had less positive visual outcomes due to the development of cataract in some cases.
“The long follow-up showed that dexamethasone intravitreal implant seems to be a safe and effective treatment for this disease, requiring a limited number of injections,” the authors said. They said that the value of this study was to prove that in a real-life situation, in which no strict criteria were adopted for inclusion, results were similar to those seen in previous randomized clinical trials. – by Michela Cimberle
Disclosures: The authors report no relevant financial disclosures.
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