Clinical Studies:

Mead

Summarized by Abtin Shahlaee, MD (Vitreoretinal Surgery Fellow, Wills Eye Hospital)

Citation: Boyer DS, Yoon YH, Belfort R Jr, Bandello F, Maturi RK, Augustin AJ, Li XY, Cui H, Hashad Y, Whitcup SM; Ozurdex MEAD Study Group. Three-year, randomized, sham-controlled trial of dexamethasone intravitreal implant in patients with diabetic macular edema. Ophthalmology. 2014 Oct;121(10):1904-14.

doi: 10.1016/j.ophtha.2014.04.024. Epub 2014 Jun 4. PMID: 24907062.

  • Objective

    To evaluate the safety and efficacy of dexamethasone intravitreal implant (Ozurdex, DEX implant) 0.7 and 0.35 mg in the treatment of patients with diabetic macular edema (DME).

  • STUDY DESIGN

    Two randomized, multicenter, masked, sham-controlled, phase III clinical trials with identical protocols and pooled data.

  • DURATION

    36 months

STUDY SUBJECTS

Major inclusion criteria:


RANDOMIZATION SCHEME AND INTERVENTIONS

Randomized 1:1:1 to


Patients were eligible for retreatment with DEX implant only if there had been ≥6 months since the most recent study treatment and there was evidence of residual edema..


RESULTS (36 months)

Study population


Visual acuity end-points


Anatomic outcomes

Adverse events


CONCLUSIONS