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Rubens Belfort, Jr., David S Boyer, Young Hee Yoon, Francesco Bandello, Raj K Maturi, Albert J Augustin, Xiao-Yan Li, Harry Cui, Yehia Hashad, Scott M Whitcup, ; Three-year, Randomized, Sham-controlled, Phase III Study of Dexamethasone Intravitreal Implant in Patients with Diabetic Macular Edema. Invest. Ophthalmol. Vis. Sci. 2014;55(13):1706.
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© ARVO (1962-2015); The Authors (2016-present)
To evaluate the safety and efficacy of dexamethasone intravitreal implant (Ozurdex, DEX implant) 0.7 mg and 0.35 mg in the treatment of diabetic macular edema (DME).
Pooled data analysis of results from two 3-year, randomized, multicenter, masked, sham-controlled, phase III clinical trials with identical protocols. Patients (n=1048) with DME, best-corrected visual acuity (BCVA) between 34 and 68 ETDRS letters, and central subfield retinal thickness (CRT) ≥300 µm by optical coherence tomography (OCT) were randomized in a 1:1:1 ratio to treatment with DEX implant 0.7 mg, DEX implant 0.35 mg, or sham procedure. Patients who met retreatment eligibility criteria could be retreated no more often than every 6 months. The primary endpoint for the United States FDA was achievement of ≥15-letter improvement in BCVA from baseline at study end in the intent-to-treat population with last-observation-carried-forward for missing values. Safety measures included adverse events (AEs) and intraocular pressure (IOP).
Mean number of treatments received over 3 years was 4.1 for DEX implant 0.7 mg, 4.4 for DEX implant 0.35 mg, and 3.3 for sham. 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 during the study was greater with DEX implant 0.7 mg (-111.6 µm) and DEX implant 0.35 mg (-107.9 µm) than sham (-41.9 µm) (P<0.001, area-under-the-curve approach). Rates of cataract-related AEs 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. IOP increases were usually controlled with medication or no therapy; only 1 (0.3%) patient treated with DEX implant 0.7 mg and 1 (0.3%) treated with DEX implant 0.35 mg underwent glaucoma incisional surgery for steroid-induced IOP increases.
DEX implant 0.7 mg and 0.35 mg provided statistically and clinically significant improvement in BCVA and reduction in CRT with an average of only 4-5 injections over 3 years. The safety profile was favorable.
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