a University Eye Clinic of Genoa , IRCCS Ospedale Policlinico San Martino , Genoa , Italy.
b Department of Neurosciences, Rehabilitation, Ophthalmology, Genetics , Maternal and Child Health (DiNOGMI), University of Genoa , Genoa , Italy.
Expert Opin Biol Ther. 2019 Aug;19(8):735-751. doi: 10.1080/14712598.2019.1627322. Epub 2019 Jun 13.
: Although several approaches have been studied for treating wet age-related macular degeneration (w-AMD), currently, the most effective strategy in the management of this visual disorder is represented by anti-VEGF drugs. Among them, ranibizumab (RBZ) is widely adopted in clinical practice for treating w-AMD. : VEGF (vascular endothelial growth factor) is a hypoxia-induced growth factor promoting neoangiogenesis, which has been correlated to the pathogenesis of w-AMD. RBZ is a humanized, recombinant, monoclonal antibody fragment (Fab), which binds all the isoform of VEGF-A and, therefore, exerts an inhibitory activity on the growth of new pathological vessels leading to the reabsorption of VEGF-related macular edema. The pivotal trials ANCHOR and MARINA revealed its clinical efficacy and good safety profile for treating w-AMD, leading ultimately to its FDA approval. Further trials have analyzed the best dosage and regimen modality, reporting RBZ at 0.5 mg with a 'pro re nata' regimen (PRN) to be non-inferior to the 0.5 mg formulation administered monthly. The treat-to-extend (TAE) regimen has also been investigated, demonstrating encouraging results in terms of clinical efficacy and nonetheless, it was proven to be a well-tolerated option with the possibility of reducing the treatment burden for the patients. : RBZ has been proven to be an effective anti-VEGF agent for treating w-AMD; however, more optimal therapeutic regimens and drug delivery systems are being investigated in order to improve patients' compliance and treatment burden.
虽然已经研究了几种方法来治疗湿性年龄相关性黄斑变性(w-AMD),但目前,治疗这种视觉障碍最有效的策略是抗 VEGF 药物。其中,雷珠单抗(RBZ)广泛应用于治疗 w-AMD 的临床实践中。VEGF(血管内皮生长因子)是一种缺氧诱导的生长因子,可促进新生血管形成,与 w-AMD 的发病机制有关。RBZ 是一种人源化、重组、单克隆抗体片段(Fab),可结合所有 VEGF-A 异构体,从而对新的病理性血管生长产生抑制作用,导致 VEGF 相关的黄斑水肿吸收。关键性试验 ANCHOR 和 MARINA 揭示了其治疗 w-AMD 的临床疗效和良好的安全性,最终使其获得 FDA 批准。进一步的试验分析了最佳剂量和方案模式,报告 0.5mg RBZ 的“按需治疗”(PRN)方案与每月给药的 0.5mg 制剂等效。还研究了治疗至扩展(TAE)方案,该方案在临床疗效方面显示出令人鼓舞的结果,但也被证明是一种耐受性好的选择,有可能减轻患者的治疗负担。RBZ 已被证明是治疗 w-AMD 的一种有效的抗 VEGF 药物;然而,正在研究更优化的治疗方案和药物输送系统,以提高患者的依从性和治疗负担。