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C. Schmucker, C. Ehlken, L. Hansen, G. Antes, H. Agostini, M. Lelgemann; Intravitreal Bevacizumab (Avastin®) vs. Ranibizumab (Lucentis®) for the Treatment of Age-Related Macular Degeneration: Systematic Review. Invest. Ophthalmol. Vis. Sci. 2009;50(13):2510.
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We conducted a systematic review to evaluate whether the existing evidence justifies the intravitreal use of bevacizumab in age-related macular degeneration (AMD) without drug approval neither by EMEA nor FDA. In this context, we evaluated efficacy and safety of off-label bevacizumab in comparison to ranibizumab in the treatment of AMD.
Four databases (Cochrane Library, Embase, Medline, PreMedline) were searched with no limitations of study design, language and year of publication. The searches were supplemented by handsearching the bibliographies of included studies and reviews. Included were studies which evaluated bevacizumab or ranibizumab as monotherapy against any other AMD treatment. Case series were included if they met predefined quality standards.
Of 3672 citations retrieved, 8 RCTs (4 evaluating ranibizumab vs PDT, Sham or usual care with a total of 1392 patients; 4 evaluating bevacizumab vs PDT±triamcinolone with a total of 287 patients) and 19 case series examining bevacizumab including a total of 1838 patients were analysed. RCTs comparing ranibizumab or bevacizumab vs PDT showed significant improvements in visual acuity (VA) in favour of the VEGF inhibitor (relative improvement 30% to 35%). In addition, in none of the included publications a significant decrease in VA was reported under the use of the VEGF antibodies. However, in contrast to the studies examining ranibizumab, the findings with bevacizumab were limited in the validity and reliability based on the low number of patients included in the RCTs, inadequate blinding and variations in treatment modalities.Regarding safety data, ocular and systemic adverse effects seem to be less dominant using bevacizumab. But again, the validity of this finding is strongly limited by inadequate reporting and short follow up times.
The evidence of bevacizumab is limited by methodological weaknesses of the studies currently available. Therefore, the widespread off-label use of bevacizumab is presently not fully justified in clinical practice. These results underline the need for clinical trials comparing bevacizumab with ranibizumab.
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