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

• DOI: 10.1016/j.ophtha.2014.04.024
• Publication Date: 2014-06-04T05:31:01Z
• Authors: David S. Boyer; Young Hee Yoon; Rubens Belfort; Francesco Bandello; Raj K. Maturi; Albert J. Augustin; Xiao-Yan Li; Harry Cui; Yehia Hashad; Scott M. Whitcup
• Keywords: Clinical endpoint; Diabetic macular edema

To evaluate the safety and efficacy of dexamethasone intravitreal implant (Ozurdex, DEX implant) 0.7 0.35 mg in treatment patients with diabetic macular edema (DME).Two randomized, multicenter, masked, sham-controlled, phase III clinical trials identical protocols were conducted. Data pooled for analysis.Patients (n = 1048) DME, best-corrected visual acuity (BCVA) 20/50 to 20/200 Snellen equivalent, central retinal thickness (CRT) ≥300 μm by optical coherence tomography.Patients randomized a 1:1:1 ratio study mg, or sham procedure followed 3 years (or 39 months treated at month 36) ≤40 scheduled visits. Patients who met retreatment eligibility criteria could be retreated no more often than every 6 months.The predefined primary endpoint United States Food Drug Administration was achievement ≥15-letter improvement BCVA from baseline end. Safety measures included adverse events intraocular pressure (IOP).Mean number treatments received over 4.1, 4.4, 3.3 sham, respectively. The percentage end greater (22.2%) (18.4%) (12.0%; P ≤ 0.018). Mean average reduction CRT (-111.6 μm) (-107.9 (-41.9 μm; < 0.001). Rates cataract-related phakic eyes 67.9%, 64.1%, 20.4% groups, Increases IOP usually controlled medication therapy; only 2 (0.6%) group 1 (0.3%) required trabeculectomy.The BCVA. profile acceptable consistent previous reports.