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Ronald P Danis, Srinivas R Sadda, Harry Cui, Xiao-Yan Li, Yehia Hashad, Scott M Whitcup, ; Anatomic Outcomes with Dexamethasone Intravitreal Implant in Diabetic Macular Edema: a Pooled Analysis of Two Randomized Phase 3 Trials. Invest. Ophthalmol. Vis. Sci. 2014;55(13):5051.
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To assess anatomic outcomes with dexamethasone intravitreal implant [DEX implant] (Ozurdex®, Allergan Inc., Irvine, CA) 0.7 and 0.35 mg in the treatment of diabetic macular edema (DME).
Two multicenter, randomized, sham-controlled Phase 3 trials of DEX implant (NCT00168337 and NCT00168389), with identical protocols, were conducted and data were pooled for analysis. Patients with DME, best-corrected visual acuity (BCVA) of 34 - 68 letters (20/200 - 20/50 Snellen equivalent), and retinal thickness in the 1-mm central subfield (CRT) ≥300 µm were randomized to treatment with DME implant 0.7 mg, DEX implant 0.35 mg, or sham procedure and followed for 3 years. Study visits occurred at 6-week (Year 1) and 3-month (Years 2 and 3) intervals; retreatment was permitted at ≥6-month intervals. Time-domain optical coherence tomography and fundus photography images were evaluated by a central reading facility.
The study eye of 1048 patients (mean age 62.4 years) received (mean) 4.1, 4.4, and 3.3 treatments with DEX 0.7 mg implant, DEX 0.35 mg implant, and sham, respectively, over 3 years. At all time points DEX 0.7mg and 0.35 mg implant reduced CRT (mean change from baseline to study end: -117.3 and -127.8 µm, respectively; mean average change [area-under-curve approach] over study period: -111.6 and -107.9 µm, respectively; all P<0.001 vs sham), and reduced macular volume (mean change from baseline to study end: -1.06 and -1.14 mm3, respectively; both P<0.001 vs sham). DEX 0.7 mg and 0.35 mg implant reduced disc areas of macular thickening on color photographs (mean change from baseline to study end: -2.753 and -2.931, respectively; both P<0.001 vs sham). More DEX 0.7mg and 0.35 mg implant- than sham-treated eyes showed improvement in clinically significant macular edema (retinal thickening ≥1 disc area, part ≤1 disc diameter from center, or retinal thickening or adjacent hard exudates ≤500 μm from center) (20.4% and 22.4%, respectively, vs 12.4% at study end; both P<0.05 vs sham). DEX 0.7mg implant reduced the risk in time to 2-step worsening in Diabetic Retinopathy Severity Score by 44% over the study period (P=0.03 vs sham).
DEX 0.7 mg or 0.35 mg implant, administered at ≥6-month intervals over 3 years, provided rapid and sustained improvement in retinal thickening and delayed progression of retinopathy in patients with DME.
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