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Ling Zhi Heng, Sobha Sivaprasad, Roxanne R Crosby-Nwaobi, Zubin Saihan, Michael Kerampelas, Catey Bunce, Tunde Peto, Philip G Hykin, OZLASE; A prospective randomised controlled clinical trial comparing a combination of repeated intravitreal Ozurdex and macular laser therapy versus macular laser monotherapy in centre-involving diabetic macular edema (OZLASE study).. Invest. Ophthalmol. Vis. Sci. 2015;56(7 ):1746.
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To evaluate the clinical efficacy and safety of combined repeated Ozurdex and macular laser therapy (MLT) compared to MLT monotherapy in participants with visual impairment due to centre-involving diabetic macular oedema (DMO).<br />
Eighty participants with best corrected visual acuity (BCVA) between 54 to 78 ETDRS letters due to centre-involving DMO were randomized to combination therapy with Ozurdex and MLT or MLT only. The combination arm received mandated Ozurdex injections at baseline and 16 weeks followed by re-treatment criteria guided PRN therapy at 32 and 48 weeks. Participants randomized to MLT only were treated every 16 weeks if clinically significant macula oedema was present. The pre-specified primary efficacy evaluation was the mean change from baseline in BCVA at week 56 measured as ETDRS letter score in the intent-to-treat (ITT) population of all randomized patients after adjusting for baseline visual acuity<br />
The mean change in BCVA at 56 weeks was -0.3 (SD 11.4) ETDRS letters in the combination arm versus +0.4 (SD 9.6) ETDRS letters in the MLT arm (effect estimate 1.15 (95% CI -3.32, 5.61)). However, at 56 weeks the central subfield thickness decreased by -113um (IQR -218,-64) [combination] vs -17um (-128, 12) [MLT arm] (p<0.001). Elevated IOP requiring topical therapy was observed in 8(20 %) eyes in the combination versus 1(2.5%) in the MLT arm. 33% (9/27) of phakic participants in the combination arm underwent cataract surgery.<br /> <br />
Visual outcome following combination therapy did not differ from MLT alone in centre-involving DMO despite a significant decrease in CST likely due to an entry VA related ceiling effect and cataract development.<br />
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