Off-Label Use of Bevacizumab in Age-Related Macular Degeneration: Protocol for a Systematic Review and Meta-Analysis

Abstract Background: Age-related macular degeneration (AMD) is considered the leading cause of vision loss in elderly people. Taking into account the phenomenon of aging worldwide, the prevalence of AMD is expected to increase gradually in the future. AMD can be divided into early, intermediate and late stages, where early and intermediate are mainly asymptomatic and, late-stage can be classified in non-vascular AMD and vascular AMD. Current pharmacological treatment in vascular AMD is associated with the administration of anti-VEGF agents, such as ranibizumab, pegaptanib, and aflibercept. Additionally, it has been reported the off-label use of bevacizumab, commonly associated with oncology, in this condition through intravitreal administrations, demonstrating efficacy allied with a lower cost in comparison to other agents used, which makes it a new possible pharmacological approach. In this sense, this review aims to evaluate the off-label use profile of bevacizumab in the treatment of neovascular AMD. Methods/design: To identify and select relevant articles present in current literature, it will be developed a highly sensitive search strategy. To develop this search, it will be used MEDLINE via the Pubmed platform. It will be only considered clinical studies, where it is compared the use of bevacizumab with another pharmacological agent, such as ranibizumab, or even a placebo, in patients aged 50 years and older, diagnosed with vascular AMD.Discussion: This review will provide a synthesis of the current information and underlying evidence, about the influence of the off-label use of bevacizumab in this disease. Altogether, it will allow having a clearer vision on a new possible accepted pharmacological approach for the treatment of vascular AMD.Systematic review registration: The protocol for this review will be submitted and registered with the International Prospective Register of Systematic Reviews (PROSPERO).