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S. Sacu, A. Varga, G. Weigert, S. Michels, P. Vécsei-Marlovits, U. Schmidt-Erfurth; Comparison of Reduced Fluence versus Standard Fluence Verteporfin Therapy in Combination With Intravitreal Triamcinolone Acetonide: A Prospective, Randomized, Controlled Clinical Trial. Invest. Ophthalmol. Vis. Sci. 2007;48(13):1831.
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To compare functional and anatomic effects of reduced fluence (RF) and standard fluence (SF) verteporfin therapy (PDT) combined with intravitreal triamcinolone acetate (IVTA) in patients with neovascular age-related macular degeneration (AMD).
Forty eyes of 40 patients with neovascular AMD were enrolled in a prospective, randomized, double blinded trial. The study was approved by the ethics committee at the Medical University Vienna and registered at the European Clinical Trial Database. Patients either received RF PDT (n=20) or SF PDT (n=20) each followed by same day 4mg IVTA. Follow-up examinations were at 1 day, 1 week, 1 and 3 months. Best corrected visual acuity (BCVA) using ETDRS charts, fluorescein angiography (FA), and indocyanin green angiography (ICGA) were performed at each of follow-up visit. Macular sensitivity (MS) was evaluated using Microperimetry 1 (MP1, Nidek). BCVA, MS and central retinal thickness (CRT) were defined as primary outcomes, chorioretinal perfusion, perfusion of the neovascular net and the retreatment rate as secondary outcomes.
Baseline characteristics were well balanced in both groups. Both treatment groups showed a similar course regarding BCVA and CRT (p>0.05). At month 3 patients showed stabilisation in mean BCVA of -3 letters in the RF PDT-IVTA group versus -4 letters in SF PDT-IVTA (p>0.05). Compared to baseline both treatment groups showed a considerable increase in mean CRT at day 1 and a significant reduction of CRT at months 1 and 3. There was a trend for better MP1 outcomes in the RF PDT-IVTA group with regard to mean MS. Mean change in MS at month 3 was +1.3db in the RF PDT-IVTA group versus -0.3db in the SF PDT-IVTA group. In 53% of RF PDT-IVTA patients a recurrent CNV was observed, whereas in SF PDT-IVTA group a recurrent rate of 78% was documented. Evaluation of early FA and ICGA demonstrated less effect on the choroid in the RF PDT-IVTA group.
At month 3, RF PDT-IVTA group showed a trend of a better macular sensitivity, less effect on the choroid and a significantly lower recurrent rate than SF PDT-IVTA group. Further follow-up of this study will provide information on long-term functional results and treatment durability.
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