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R.A. Costa, D. Calucci, L.A. Melo, Jr, J.A. Cardillo, R. Jorge; Two–Fold Illumination PDT Scheme for Subfoveal CNV in Pathologic Myopia: Six–Month Efficacy and Safety Results of a Randomized, Double–Masked, Active–Controlled Clinical Trial . Invest. Ophthalmol. Vis. Sci. 2005;46(13):299.
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© ARVO (1962-2015); The Authors (2016-present)
Purpose:To compare the effectiveness and safety of standard verteporfin photodynamic therapy (PDT) to modified PDT regimen using a two–fold illumination scheme for treating choroidal neovascularization (CNV) in pathologic myopia. Methods:Double–masked, active–controlled, randomized clinical trial including patients with subfoveal CNV caused by pathologic myopia and ETDRS best–corrected visual acuity (BCVA) of 20/320 or better. Sixteen patients were randomly assigned (1:1) to standard PDT regimen (50 J/cm2; n=8) or two–fold illumination PDT scheme (50+50 J/cm2; n=8). Comprehensive ophthalmic evaluation including fluorescein angiography and OCT was performed at weeks 1, 12 ±2, and 24 ±2 following treatment. At 12–week follow–up examination, an additional treatment session with either standard or modified PDT regimens (as assigned at baseline) was applied to areas of fluorescein leakage if present. Change from baseline in ETDRS BCVA score and incidence of adverse events were primarily evaluated. Results:All patients completed the 24–week study period. Baseline median BCVA was 20/100 and 20/100 –2 for patients assigned to standard and modified PDT regimens, respectively. Median change from baseline in BCVA (LogMAR values) was –0.18*, –0.04, and –0.05 for patients submitted to standard PDT regimen, and –0.18*, –0.19*, and –0.24* for patients submitted to two–fold illumination PDT scheme at follow–up examinations 1, 12, and 24 weeks after treatment, respectively (*p<0.05; Wilcoxon signed–rank test). At week 24, median change in BCVA was significantly greater in patients submitted to two–fold illumination PDT scheme (p=0.005; Mann–Whitney U test). An additional PDT session was performed in 7/8 patients assigned to standard PDT regimen, and in 4/8 patients assigned to modified PDT (p=0.28; Fisher’s exact test). No PDT–related complications were observed. Conclusions:Although the number of patients and length of follow–up in this study was limited, a significant better visual outcome and diminished retreatment rate were observed in patients assigned to two–fold illumination PDT scheme in comparison to those submitted to standard PDT regimen. Larger studies with longer follow–up to look at modified PDT regimen versus standard one to confirm our preliminary promising results are highly advisable.
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