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- Off-label use of bevacizumab in age-related macular degeneration: protocol for a systematic review and meta-analysisPublication . Estarreja, João; Valente, Carina; Silva, Carina; Camacho, Pedro; Mateus, VanessaBackground: Age-related macular degeneration (AMD) is recognized as 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, late-stage can be classified as non-vascular AMD and vascular AMD. Current pharmacological treatment in vascular AMD includes the administration of anti-VEGF agents, such as ranibizumab, pegaptanib, and aflibercept. Additionally, it has been reported that the off-label use of bevacizumab, through intravitreal administrations, demonstrates to be effective along with a lower cost in comparison to other agents used, which makes it a new possible pharmacological approach. Objective: This review aims to evaluate the efficacy, safety, and efficiency of the use of bevacizumab in the treatment of neovascular AMD. Methods: 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 randomized controlled clinical trials, 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. Results: This project has no funding and it has been done by a multidisciplinary research team of pharmacologists and orthoptists. The study was initiated in May 2021 with the lineation of the protocol, now the data are been extracted and analyzed, and it is expected to be released by the end of 2022. Conclusions: 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 of a new possible accepted pharmacological approach for the treatment of vascular AMD. Clinical Trial: The protocol for this review was registered in the International Prospective Register of Systematic Reviews (PROSPERO) with the code CRD42021244931.
- Correction: The efficacy, safety, and efficiency of the off-label use of bevacizumab in patients diagnosed with age-related macular degeneration: protocol for a systematic review and meta-analysisPublication . Estarreja, João; Mendes, Priscila; Silva, Carina; Camacho, Pedro; Mateus, Vanessa[This corrects the article DOI: 10.2196/38658.]
- Off-label use of bevacizumab in patients diagnosed with age-related macular degeneration: a systematic review and meta-analysisPublication . Estarreja, João; Mendes, Priscila; Silva, Carina; Camacho, Pedro; Mateus, VanessaBackground: Age-related macular degeneration (AMD) is the leading cause of vision loss in elderly people. Current pharmacological treatment in vascular AMD includes anti-VEGF agents, such as ranibizumab and aflibercept. Additionally, the off-label use of bevacizumab has been shown to be effective and has a lower cost, making it an interesting pharmacological approach; however, there is no consensus about its use. Therefore, this systematic review and meta-analysis aims to evaluate the efficacy, safety, and efficiency of bevacizumab in AMD patients. Methods: This review only focused on randomized controlled clinical trials published in 2010 in the MEDLINE database that compared the effect of bevacizumab with ranibizumab. The risk of bias in each included study was assessed using the CASP Randomised Clinical Trials checklist. Results: Twelve studies were included for qualitative synthesis, and nine of them were considered for meta-analysis. Bevacizumab-treated patients showed a significantly reduced neovascularization in a longer spectrum of time; however, they had a higher incidence of endophthalmitis than those treated with ranibizumab. Regarding efficiency, the mean number of administrations was reduced in the treatment with bevacizumab in comparison to ranibizumab. Conclusions: Clinical evidence demonstrates that bevacizumab has efficacy and safety profiles comparable with ranibizumab; however, it is relatively more efficient.
- The efficacy, safety, and efficiency of the off-label use of bevacizumab in patients diagnosed with age-related macular degeneration: protocol for a systematic review and meta-analysisPublication . Estarreja, João; Mendes, Priscila; Silva, Carina; Camacho, Pedro; Mateus, VanessaBackground: Age-related macular degeneration (AMD) is recognized as the leading cause of vision loss in older people. Considering the phenomenon of aging societies worldwide, the prevalence of AMD is expected to increase gradually in the future. AMD can be divided into early, intermediate, and late stages, with the early and intermediate stages being mainly asymptomatic, and the late stage being classified as geographic atrophy, neovascular AMD, or both. Current pharmacological treatments for neovascular AMD include anti-vascular endothelial growth factors agents, such as ranibizumab, pegaptanib, and aflibercept. Additionally, it has been reported that the off-label use of intravitreally administered bevacizumab is effective. It is also lower cost than other agents, which makes it an interesting pharmacological approach. Objective: This review aims to evaluate the efficacy, safety, and efficiency of bevacizumab for the treatment of neovascular AMD. Methods: This review will only consider randomized controlled clinical trials that compare the use of bevacizumab with another pharmacological agent or placebo in patients aged 50 years and older who are diagnosed with vascular AMD. It will exclude studies that include participants diagnosed with polypoidal choroidal vasculopathy or retinal angiomatous proliferation. To identify and select relevant articles, we will develop a highly sensitive search strategy and apply it in MEDLINE via the PubMed platform. Upon selection of the studies and analysis of the titles, abstracts, and full texts, the results will be presented according to the Preferred Reporting Items of Systematic Reviews and Meta-Analyses (PRISMA) guidelines. The analysis and extraction of the data will be performed by 2 independent reviewers. The risk of bias will be evaluated with the Critical Appraisal Skills Programme (CASP) checklist. Finally, the same reviewers will also perform a quality assessment of the included studies with the Grading of Recommendations, Assessment, Development, and Evaluations (GRADE) tool. Results: The search strategy, after the application of the inclusion and exclusion criteria, identified 15 randomized clinical trials, which are currently being analyzed. This project has no funding and it has been developed by a multidisciplinary research team of pharmacologists and orthoptists. The study was initiated in May 2021 and it is expected to conclude by the end of 2023. Conclusions: This review will provide a synthesis of current information and underlying evidence about the off-label use of bevacizumab in neovascular AMD. It will provide a clearer vision of a possible new pharmacological approach, as well as the most suitable treatment designs, for the treatment of neovascular AMD.