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Young Hee Yoon, David S Boyer, Rubens Belfort, Jr., Francesco Bandello, Raj K Maturi, Albert J Augustin, Xiao-Yan Li, Harry Cui, Yehia Hashad, Scott M Whitcup, ; Long-term Efficacy and Safety of Dexamethasone Intravitreal Implant in Phakic and Pseudophakic Eyes with Diabetic Macular Edema. Invest. Ophthalmol. Vis. Sci. 2014;55(13):1779.
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To evaluate the efficacy and safety of dexamethasone intravitreal implant (Ozurdex, DEX implant) 0.7 mg and 0.35 mg for treatment of diabetic macular edema (DME) in phakic and pseudophakic eyes.
Subgroup analysis of pooled data from two 3-year, randomized, multicenter, masked, sham-controlled, phase III clinical trials with identical protocols. Patients (n=1048) were randomized in a 1:1:1 ratio to treatment with DEX implant 0.7 mg, DEX implant 0.35 mg, or sham procedure in the study eye. 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.
Baseline lens status in the study eye was phakic in 773 (73.8%) patients and pseudophakic in 275 (26.2%) patients. The percentage of patients with ≥15-letter improvement in BCVA from baseline at study end in the DEX implant 0.7 mg, DEX implant 0.35 mg, and sham groups, respectively, was 22.2%, 18.4%, and 12.0% overall (P≤0.018 for DEX implant 0.7 and 0.35 mg vs sham); 21.9%, 19.3%, and 12.4% among baseline phakic patients (P≤0.035 for DEX implant 0.7 and 0.35 mg vs sham); and 23.3%, 15.9%, and 10.9% among baseline pseudophakic patients (P=0.024 for DEX implant 0.7 mg vs sham). Mean average reduction in CRT from baseline during the study (area-under-the-curve approach) was greater with DEX implant 0.7 and 0.35 mg than sham in both baseline phakic patients (-104.9, -104.8, and -38.3 µm; P<0.001) and baseline pseudophakic patients (-131.8, -117.1, and -50.8 µm; P<0.001). Rates of cataract-related adverse events in baseline phakic patients were 67.9%, 64.1%, and 20.4%. 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 intraocular pressure increases.
With an average of only 4-5 injections over 3 years, DEX implant 0.7 mg and 0.35 mg provided clinically significant improvement in BCVA and reduction in CRT in phakic as well as pseudophakic eyes. The safety profile was favorable.
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