Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong, Hong Kong Eye Hospital, Kowloon, Hong Kong.
Clin Interv Aging. 2013;8:467-83. doi: 10.2147/CIA.S36811. Epub 2013 Apr 29.
Neovascular age-related macular degeneration (AMD) and diabetic macular edema (DME) are major causes of visual impairment in the elderly population worldwide. With the aging population, the prevalence of neovascular AMD and DME has increased substantially over the recent years. Vascular endothelial growth factor (VEGF) has been implicated as playing an important role in the pathogenesis of both neovascular AMD and DME. Since its introduction in 2006, ranibizumab, a recombinant, humanized, monoclonal antibody fragment against all isoforms of VEGF-A, has revolutionized the treatment of neovascular AMD and DME. The efficacy and safety of ranibizumab in neovascular AMD has been demonstrated in the ANCHOR and MARINA trials. Further studies including the PIER, PrONTO, and SUSTAIN trials have also evaluated the optimal dosing regimen of ranibizumab in neovascular AMD. The CATT and IVAN trials compared the safety and efficacy of ranibizumab with off-label use of bevacizumab. Studies such as SUSTAIN and HORIZON have shown that ranibizumab has a good safety profile and is well tolerated for over 4 years with very few serious ocular and systemic adverse events. For DME, Phase II RESOLVE study and Phase III RISE and RIDE studies have demonstrated superiority of ranibizumab treatment in improving vision over placebo controls. Phase II READ and Phase III RESOLVE and REVEAL studies have shown that ranibizumab is more effective both as monotherapy and in combination with laser compared with laser monotherapy. The 3-year results from the DRCRnet protocol I study found that ranibizumab with deferred laser resulted in better long-term visual outcome compared with ranibizumab with prompt laser. This review summarizes various important clinical trials on the long-term efficacy and safety of ranibizumab in the treatment of neovascular AMD and DME. The pharmacological properties of ranibizumab, its cost effectiveness, and impact on quality of life will also be discussed.
新生血管性年龄相关性黄斑变性（AMD）和糖尿病性黄斑水肿（DME）是全球老年人群视力损害的主要原因。随着人口老龄化，近年来新生血管性 AMD 和 DME 的患病率显著增加。血管内皮生长因子（VEGF）已被认为在新生血管性 AMD 和 DME 的发病机制中发挥重要作用。自 2006 年上市以来，雷珠单抗作为一种针对 VEGF-A 所有亚型的重组、人源化、单克隆抗体片段，彻底改变了新生血管性 AMD 和 DME 的治疗方法。ANCHOR 和 MARINA 试验证实了雷珠单抗治疗新生血管性 AMD 的疗效和安全性。包括 PIER、PrONTO 和 SUSTAIN 试验在内的进一步研究也评估了雷珠单抗治疗新生血管性 AMD 的最佳剂量方案。CATT 和 IVAN 试验比较了雷珠单抗与贝伐单抗的安全性和疗效。SUSTAIN 和 HORIZON 等研究表明，雷珠单抗具有良好的安全性，在超过 4 年的时间内耐受性良好，很少出现严重的眼部和全身不良事件。对于 DME，II 期 RESOLVE 研究、III 期 RISE 和 RIDE 研究表明，雷珠单抗治疗可提高视力，优于安慰剂对照。II 期 READ 和 III 期 RESOLVE 和 REVEAL 研究表明，雷珠单抗作为单一疗法和与激光联合治疗均比激光单一疗法更有效。DRCRnet 方案 I 研究的 3 年结果发现，与雷珠单抗立即联合激光相比，雷珠单抗延迟联合激光可获得更好的长期视力结果。本综述总结了雷珠单抗治疗新生血管性 AMD 和 DME 的长期疗效和安全性的各种重要临床试验。还将讨论雷珠单抗的药理学特性、成本效益以及对生活质量的影响。
