Three-Year, Randomized, Sham-Controlled Trial of Dexamethasone Intravitreal Implant in Patients with Diabetic Macular Edema

Abstract

Purpose: 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).Design: Two randomized, multicenter, masked, sham-controlled, phase III clinical trials with identical protocols were conducted. Data were pooled for analysis.Participants: Patients (n = 1048) with DME, best-corrected visual acuity (BCVA) of 20/50 to 20/200 Snellen equivalent, and central retinal thickness (CRT) of >= 300 mu m by optical coherence tomography.Methods: Patients were randomized in a 1:1:1 ratio to study treatment with DEX implant 0.7 mg, DEX implant 0.35 mg, or sham procedure and followed for 3 years (or 39 months for patients treated at month 36) at = 15-letter improvement in BCVA from baseline at study end. Safety measures included adverse events and intraocular pressure (IOP).Results: Mean number of treatments received over 3 years was 4.1, 4.4, and 3.3 with DEX implant 0.7 mg, DEX implant 0.35 mg, and sham, respectively. the percentage of patients with >= 15-letter improvement in BCVA from baseline at study end was greater with DEX implant 0.7 mg (22.2%) and DEX implant 0.35 mg (18.4%) than sham (12.0%; P <= 0.018). Mean average reduction in CRT from baseline was greater with DEX implant 0.7 mg (-111.6 mu m) and DEX implant 0.35 mg (-107.9 mu m) than sham (-41.9 mu m; P < 0.001). Rates of cataract-related adverse events in phakic eyes were 67.9%, 64.1%, and 20.4% in the DEX implant 0.7 mg, DEX implant 0.35 mg, and sham groups, respectively. Increases in IOP were usually controlled with medication or no therapy; only 2 patients (0.6%) in the DEX implant 0.7 mg group and 1 (0.3%) in the DEX implant 0.35 mg group required trabeculectomy.Conclusions: the DEX implant 0.7 mg and 0.35 mg met the primary efficacy endpoint for improvement in BCVA. the safety profile was acceptable and consistent with previous reports. (C) 2014 by the American Academy of Ophthalmology.Allergan, Inc.Retina Vitreous Associates Med Grp, Los Angeles, CA 90017 USAUniv Ulsan, Asan Med Ctr, Seoul, South KoreaUniversidade Federal de São Paulo, Vis Inst, São Paulo, BrazilUniv Vita Salute, Hosp San Raffaele, Milan, ItalyMidwest Eye Inst, Indianapolis, in USAStaedt Klinikum Karlsruhe, Dept Ophthalmol, Karlsruhe, GermanyAllergan Pharmaceut Inc, Irvine, CA USAUniversidade Federal de São Paulo, Vis Inst, São Paulo, BrazilWeb of Scienc