Danis RP, et al. Br J Ophthalmol. 2015;doi:10.1136/bjophthalmol-2015-306823.

January 06, 2016
1 min read

Intravitreal dexamethasone sustains improvements in patients with DME


Danis RP, et al. Br J Ophthalmol. 2015;doi:10.1136/bjophthalmol-2015-306823.

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Retinal structure improvements were sustained over 3 years in patients with diabetic macular edema in whom dexamethasone intravitreal implants were administered at intervals of 6 months or more, according to an analysis.

Investigators pooled data from two completed phase 3 trials. The MEAD trials were multicenter, masked, randomized studies that assessed the safety and efficacy of Ozurdex (dexamethasone intravitreal implant, Allergan) monotherapy in patients with DME.

The trials were conducted from February 2005 to June 2012 at 131 sites in 22 countries. The pooled population included 607 patients randomized equally into three groups: dexamethasone implant 0.7 mg, dexamethasone implant 0.35 mg or sham. In the studies, time-domain OCT was used at 3-month intervals, and fluorescein angiography to determine macular fluorescein leakage and perifoveal capillary integrity was performed at baseline, 6 months, 12 months, 24 months and 3 years.

At the end of 3 years, improvement in macular edema grade was greater in the 0.7 mg and 0.35 mg implant groups than in the sham group (P < .05 vs. sham). Central subfield retinal thickness was reduced by a mean of 117.3 µm in the 0.7 mg group and 127.8 µm in the 0.35 mg group compared with 62.1 µm in sham-treated eyes (both P < .001 vs. sham).

“[The] implant thus has the potential to reduce the need for laser therapy and provides an alternative to anti-VEGF therapy in DME,” the investigators wrote. – by Kate Sherrer

Disclosures: The study and medical writing support were sponsored by Allergan. Danis and Sadda report they have received grant support and consulting fees from Allergan. Li and Hashad report they are employees of Allergan. At the time of the study, Cui and Whitcup report they were employees of Allergan.