Paul Mitchell1. 1. Department of Ophthalmology, University of Sydney, Sydney, Australia. paul.mitchell@sydney.edu.au
Abstract
OBJECTIVE: To systematically review ocular and systemic events in treatment of wet age-related macular degeneration (AMD) with anti-vascular endothelial growth factor antibodies, ranibizumab and bevacizumab, and to provide a detailed perspective of their differences on clinical use, efficacy and safety. RESEARCH DESIGN AND METHODS: This review was based on a 2010 PubMed literature search performed using two separate terms: 'lucentis' OR 'ranibizumab' AND 'age-related macular degeneration' OR 'AMD' or 'avastin' OR 'bevacizumab' AND 'age-related macular degeneration' OR 'AMD'. A clinical diagnosis of wet AMD was defined by the authors of the trial reports. Clinical studies that met Level I or Level II evidence criteria were considered for review. FINDINGS: Eight large, randomized, controlled trials of ranibizumab (Level I) included 1,485 patients (range 162-716) and four open-label studies of ranibizumab (Level II) included 4,484 patients (range 32-4,300). Six studies (one Level I, five Level II) of bevacizumab included 424 patients (range 28-165). All demonstrated improvements in visual acuity. Only one study (Level II) compared the efficacy of ranibizumab and bevacizumab. Adverse ocular and systemic safety events occurring during the study were prospectively recorded for ranibizumab, irrespective of their suspected relationship to study treatments. Only three of six bevacizumab studies reported details of adverse ocular or systemic events. There was extensive Level I and Level II evidence to support both the efficacy and safety of ranibizumab in wet AMD. Data suggest that bevacizumab provides efficacy in wet AMD, but the safety profile of intravitreal bevacizumab remains to be established. CONCLUSION: In contrast to ranibizumab, current safety data for bevacizumab are incomplete and not yet robust. If the medical community remains committed to using intravitreal bevacizumab, it is critical to establish that it has an acceptable safety profile, supported by evidence-based medicine. Considerable further research is warranted to achieve this.
OBJECTIVE: To systematically review ocular and systemic events in treatment of wet age-related macular degeneration (AMD) with anti-vascular endothelial growth factor antibodies, ranibizumab and bevacizumab, and to provide a detailed perspective of their differences on clinical use, efficacy and safety. RESEARCH DESIGN AND METHODS: This review was based on a 2010 PubMed literature search performed using two separate terms: 'lucentis' OR 'ranibizumab' AND 'age-related macular degeneration' OR 'AMD' or 'avastin' OR 'bevacizumab' AND 'age-related macular degeneration' OR 'AMD'. A clinical diagnosis of wet AMD was defined by the authors of the trial reports. Clinical studies that met Level I or Level II evidence criteria were considered for review. FINDINGS: Eight large, randomized, controlled trials of ranibizumab (Level I) included 1,485 patients (range 162-716) and four open-label studies of ranibizumab (Level II) included 4,484 patients (range 32-4,300). Six studies (one Level I, five Level II) of bevacizumab included 424 patients (range 28-165). All demonstrated improvements in visual acuity. Only one study (Level II) compared the efficacy of ranibizumab and bevacizumab. Adverse ocular and systemic safety events occurring during the study were prospectively recorded for ranibizumab, irrespective of their suspected relationship to study treatments. Only three of six bevacizumab studies reported details of adverse ocular or systemic events. There was extensive Level I and Level II evidence to support both the efficacy and safety of ranibizumab in wet AMD. Data suggest that bevacizumab provides efficacy in wet AMD, but the safety profile of intravitreal bevacizumab remains to be established. CONCLUSION: In contrast to ranibizumab, current safety data for bevacizumab are incomplete and not yet robust. If the medical community remains committed to using intravitreal bevacizumab, it is critical to establish that it has an acceptable safety profile, supported by evidence-based medicine. Considerable further research is warranted to achieve this.
Authors: Sharon D Solomon; Kristina Lindsley; Satyanarayana S Vedula; Magdalena G Krzystolik; Barbara S Hawkins Journal: Cochrane Database Syst Rev Date: 2014-08-29