Department of Ophthalmology, Queen's University, Canada.
Curr Opin Ophthalmol. 2011 May;22(3):152-8. doi: 10.1097/ICU.0b013e32834595d0.
This paper reviews the recent literature regarding the effectiveness, efficacy and safety of intravitreal bevacizumab as compared with ranibizumab for the treatment of neovascular age-related macular degeneration (nAMD).
Numerous randomized clinical trials have demonstrated the safety and efficacy of ranibizumab for the treatment of nAMD. Bevacizumab, developed, labeled and approved for the management of colorectal cancer, has been used off-label for the management of nAMD. However, given its lower cost and effectiveness, it is commonly used for many cases of nAMD. Recent clinical trials have demonstrated similar effectiveness between the two compounds in terms of visual acuity and central macular thickness. However, emerging data have suggested that these two compounds may have different ocular and systemic adverse event profiles; bevacizumab has been linked to both a higher risk of severe intraocular inflammation and a higher risk of incident arterial thromboembolic events. This incremental risk for both ocular and systemic adverse events may have an impact on the incremental cost-effectiveness ratio derived from health economic models that directly compare one anti-vascular endothelial growth factor (VEGF) compound to the other.
Numerous clinical trials, including the Comparison of AMD Treatment Trial, are underway examining the comparative efficacy of ranibizumab versus bevacizumab for the treatment of nAMD. While these studies may demonstrate clinical noninferiority of one anti-VEGF compound over another, they may not be adequately powered to detect important differences in ocular and systemic safety. Large-scale, appropriately powered safety studies need to be conducted to evaluate differences in safety.
本文回顾了近期关于玻璃体内注射贝伐单抗和雷珠单抗治疗新生血管性年龄相关性黄斑变性（nAMD）的疗效、功效和安全性的文献。
许多随机临床试验已经证实了雷珠单抗治疗 nAMD 的安全性和有效性。贝伐单抗是一种针对结直肠癌的药物，研发、标记和批准用于结直肠癌的治疗，已被用于 nAMD 的治疗。然而，由于其较低的成本和有效性，它通常用于许多 nAMD 的病例。最近的临床试验表明，这两种药物在视力和中心黄斑厚度方面的疗效相似。然而，新出现的数据表明，这两种药物可能具有不同的眼部和全身不良事件谱；贝伐单抗与严重眼内炎症风险增加和动脉血栓栓塞事件风险增加有关。这些眼部和全身不良事件的增量风险可能会影响直接比较一种抗血管内皮生长因子（VEGF）药物与另一种药物的健康经济学模型得出的增量成本效益比。
正在进行许多临床试验，包括 AMD 治疗比较试验，以检查雷珠单抗与贝伐单抗治疗 nAMD 的疗效比较。虽然这些研究可能表明一种抗 VEGF 药物在临床非劣效性方面优于另一种药物，但它们可能没有足够的效力来检测眼部和全身安全性的重要差异。需要进行大规模、适当的安全性研究，以评估安全性差异。
