Long-term effectiveness of ranibizumab for age-related macular degeneration and diabetic macular edema.
Long-term effectiveness of ranibizumab for age-related macular degeneration and diabetic macular edema.
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DOI：
10.2147/cia.s36811
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发表时间：
2013
影响因子：
3.6
通讯作者：
Lai TY
中科院分区：
文献类型：
--
作者：
Fong AH;Lai TY
新生血管性老年性黄斑变性(AMD)和糖尿病黄斑水肿(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)被认为在新生血管性AMD和DME的发病机制中起重要作用。自2006年推出以来，雷尼比珠单抗是一种重组的、人源化的、抗血管内皮生长因子-A所有亚型的单抗片段，它彻底改变了新生血管性AMD和DME的治疗方法。雷尼比珠单抗治疗新生血管性AMD的有效性和安全性已在锚和码头试验中得到证实。包括PIER、PROTO和ADVISE试验在内的进一步研究也评估了雷尼比珠单抗治疗新生血管性AMD的最佳剂量方案。CATT和Ivan试验比较了雷尼比珠单抗和贝伐单抗的非标签使用的安全性和有效性。维持性和地平线等研究表明，雷尼比珠单抗具有良好的安全性，耐受性良好，超过4年，几乎没有严重的眼部和全身不良事件。对于DME，第二阶段的RESOLE研究和第三阶段的上升和乘车研究已经证明，雷尼比珠单抗治疗在改善视力方面优于安慰剂对照组。第二阶段读取和第三阶段解决和揭示研究表明，与单一激光治疗相比，雷尼比珠单抗作为单一治疗以及与激光联合治疗都更有效。DRCRnet方案I研究的3年结果发现，与雷尼比珠单抗和瞬发激光相比，延期激光治疗的雷尼比珠单抗具有更好的远期视觉效果。本文综述了有关雷尼比珠单抗治疗新生血管性AMD和DME的长期有效性和安全性的各种重要临床试验。还将讨论雷尼比珠单抗的药理特性、其成本效益以及对生活质量的影响。
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.