Ranibizumab治疗湿性AMD的相关研究

Ranibizumab for treatment of wet AMD

脉络膜新生血管(choroidal neovascularization,CNV)形成是湿性AMD导致视力丧失的重要因素。大量证据表明,血管内皮生长因子-A(vascular endothelial growth factor A,VEGF-A)是湿性AMD新生血管生成和血管渗漏的重要调质。VEGF的抑制剂已在临床中应用,其中,ranibizumab是一种重组的人源化抗VEGF单克隆抗体片段,能够结合并抑制VEGF,阻止血管渗漏和新生血管的形成,抑制CNV的发生。III期临床试验结果表明,ranibizumab不仅可以延缓患者视力的降低,同时相当一部分患者出现临床有意义视力提高。而且,在治疗过程中严重不良事件发生率低。ranibizumab很有可能首次使多数AMD患者获得良好而稳定的视力。2006-06-30ranibizumab经美国食品药物管理局批准应用于湿性AMD的治疗。本文简要回顾VEGF的生物学特点,临床应用的途径,同时对ranibizum-ab临床研究结果进行总结。

Choroidal neovascularization（CNV） is the leading cause of blindness in wet AMD population. Substantial evidence indicated that vascular endothelial growth factor （VEGF）-A is a major mediator of angiogenesis and vascular leakage in wet AMD. Various VEGF inhibitors have been clinically applied. Among these, Ranibizumab is a recombinant humanized monoclonal anti-VEGF antibody fragment designed to bind all forms of VEGF, thereby blocking vessel permeability and angiogenesis , preventing the formation of CNV, and inhibiting the course of CNV-related diseases. Phase Ⅲ clinical trial results showed that ranibizumab could not only slow down the vision loss but also make a significant proportion of patients experience a clinically meaningful vision gain. Furthermore, the benefit was associated with a low rate of serious adverse events. On June 30, 2006, ranibizumab was approved by the US Food and Drug Administration for the treatment of wet AMD. The article briefly reviewed the biology of VEGF and then focused on the path that led to clinical development of ranibizumab while summing up the results of clinical research. 