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F. Prager, S. Michels, S. Sacu, G. Weigert, R. Dunavölgyi, W. Geitzenauer, U. Schmidt-Erfurth; Intravitreal Bevacizumab (Avastin®) Monotherapy versus Photodynamic Therapy Plus Intravitreal Triamcinolone for Neovascular Age-Related Macular Degeneration:12 Months Results of a Prospective, Randomized, Controlled Clinical Trial. Invest. Ophthalmol. Vis. Sci. 2008;49(13):1168.
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To compare functional and anatomic outcomes of intravitreal bevacizumab (Avastin®) and photodynamic therapy (PDT) with verteporfin combined with intravitreal triamcinolone (IVTA) in patients with neovascular age-related macular degeneration (AMD).
In a prospective, randomized, controlled clinical trial 28 patients with neovascular AMD were randomized 1:1 to be either treated with intravitreal bevacizumab (IVB) or with PDT combined with IVTA (PDT-IVTA). Patients in the IVB group received three initial bevacizumab injections at a dose of 1.0mg/0.04ml at a monthly interval. Retreatment was based on optical coherence tomography (OCT) findings. Patients in the PDT-IVTA group received one PDT treatment at baseline combined with an intravitreal injection of 4mg/0.1ml triamconolone (Kenalog®) at the same day. Retreatment was based on evidence of leakage in fluorescein angiography (FA) at 3 month intervals. To evaluate functional and morphologic results, examinations included visual acuity (VA) testing using the ETDRS protocol, OCT, FA and indocyanine green angiography (ICGA).
After 12 months of follow-up mean VA had improved from 50 letters at baseline to 58 (+7.5 letters, +1.5 lines, p<0.01) in the IVB group, but decreased from 46 letters at baseline to 43 letters (- 3 letters, p=0.4) in the PDT-IVTA group (p=0.02, ANOVA, between both groups). Mean central retinal thickness (CRT) decreased from 357 µm at baseline to 244 µm (-113 µm, p<0.01) at month 12 in the IVB group and from 326 µm to 254 µm (-72µm, p=0.1) in the PDT-IVTA group (p=0.8, ANOVA, between both groups). After 12 months patients in the IVB group had received a mean of 6.8 out of 13 possible injections, whereas patients in the PDT-IVTA group had received 1.9 out of 5 possible treatments. No drug-related adverse events were seen during a 12-month follow-up.
Both treatment groups showed comparable morphological benefits. However, the functional results with impaired vision in the IVB group indicate that the change in VA appears to be not only dependent on reduction of macular fluid, but also on the treatment modality used.
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