Estarreja João, Mendes Priscila, Silva Carina, Camacho Pedro, Mateus Vanessa
Health & Technology Research Center, Escola Superior de Tecnologia da Saúde, Instituto Politécnico de Lisboa, Lisbon, Portugal.
Centro de Estatística e Aplicações, Universidade de Lisboa, Lisbon, Portugal.
JMIR Res Protoc. 2023 Jun 9;12:e38658. doi: 10.2196/38658.
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 factor 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.
This review aims to evaluate the efficacy, safety, and efficiency of bevacizumab for the treatment of neovascular AMD.
This review will only consider randomized controlled clinical trials that compare the use of bevacizumab with another pharmacological agent or a 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. 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.
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.
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.
PROSPERO CRD42021244931; https://tinyurl.com/p6m5ycpk.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/38658.
年龄相关性黄斑变性（AMD）被认为是老年人视力丧失的主要原因。鉴于全球老龄化社会的现象，预计未来AMD的患病率将逐渐上升。AMD可分为早期、中期和晚期，早期和中期主要无症状，晚期分为地图样萎缩、新生血管性AMD或两者皆有。目前用于治疗新生血管性AMD的药物包括抗血管内皮生长因子药物，如雷珠单抗、培加尼布和阿柏西普。此外，有报道称玻璃体内注射贝伐单抗的非标签使用是有效的。它的成本也比其他药物低，这使其成为一种有吸引力的药物治疗方法。
本综述旨在评估贝伐单抗治疗新生血管性AMD的疗效、安全性和有效性。
本综述仅考虑在50岁及以上被诊断为血管性AMD的患者中，比较贝伐单抗与另一种药物或安慰剂使用情况的随机对照临床试验。它将排除包括被诊断为息肉样脉络膜血管病变或视网膜血管瘤样增生的参与者的研究。为了识别和选择相关文章，我们将制定一个高度敏感的搜索策略，并通过PubMed平台在MEDLINE中应用。在选择研究并分析标题、摘要和全文后，结果将根据系统评价和Meta分析的首选报告项目（PRISMA）指南呈现。数据的分析和提取将由2名独立的评审员进行。将使用关键评估技能计划（CASP）清单评估偏倚风险。最后，同样的评审员还将使用推荐分级、评估、制定和评价（GRADE）工具对纳入的研究进行质量评估。
在应用纳入和排除标准后，搜索策略识别出15项随机临床试验，目前正在进行分析。该项目没有资金支持，由药理学家和视光师组成的多学科研究团队开展。该研究于2021年5月启动，预计2023年底结束。
本综述将综合当前关于贝伐单抗在新生血管性AMD中使用的非标签信息和潜在证据。它将为治疗新生血管性AMD提供一种可能的新药理学方法以及最合适的治疗设计的更清晰的认识。
PROSPERO CRD42021244931；https://tinyurl.com/p6m5ycpk。
国际注册报告识别码（IRRID）：DERR1-10.2196/38658。
