PURPOSE A simulated switching study assessed the effects of continuing the same anti-vascular endothelial growth factor (VEGF) treatment among patients who typically are considered for a therapy switch. Post hoc analysis of data from HARBOR was undertaken. Patients with neovascular age-related macular degeneration who demonstrated a suboptimal response after 3 or 6 months of ranibizumab treatment were identified as switching candidates. Rather than switching, however, patients continued on ranibizumab treatment, and visual and anatomic outcomes from the point of the hypothetical switch were examined. DESIGN Post hoc analysis of the phase 3 HARBOR clinical trial. PARTICIPANTS Patients were included in 3- and 6-month switcher analyses if they received 3 of 3 initial monthly ranibizumab doses and 5 of 6 initial monthly ranibizumab doses, respectively, and met all the following: 5-letter or fewer gain from baseline, best-corrected visual acuity (BCVA) 20/40 or worse, and intraretinal or subretinal fluid with central foveal thickness (CFT) equal to or greater than central subfield thickness. METHODS Patient data were examined at months 3 and 6 to identify those who met predetermined switching criteria. Best-corrected visual acuity and CFT were examined from the point at which switching criteria were met through months 6, 12, 18, and 24 of HARBOR and compared with those who did not meet the criteria. MAIN OUTCOME MEASURES Outcome measures included mean BCVA and CFT change over time from the point (month 3 or 6) at which switching criteria were met. RESULTS By months 3 and 6, only 44 of 1059 patients (4.2%) and 37 of 769 patients (4.8%), respectively, met the inclusion criteria for hypothetical switching. Patients who met switching criteria at month 3 gained, on average, 5.3 letters from months 3 to 12 and 2.7 letters from months 3 to 24. Month 6 switchers gained, on average, 1.6 letters from months 6 to 12 and 1.8 letters from months 6 to 24. Both groups experienced significant CFT reductions over 24 months. CONCLUSIONS Month 3 hypothetical switchers achieved vision and anatomic improvement while continuing their original ranibizumab treatment. Month 6 switcher outcomes replicated those commonly reported in published anti-VEGF switching studies: stable vision or nominal improvements in vision with continued substantial anatomic improvement.

中文翻译：

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在新血管性年龄相关性黄斑变性中模拟抗血管内皮生长因子开关：HARBOR亚分析。

目的一项模拟转换研究评估了在通常考虑进行治疗转换的患者中继续进行相同的抗血管内皮生长因子（VEGF）治疗的效果。进行了对HARBOR数据的事后分析。在兰尼单抗治疗3或6个月后表现出次优反应的患有新生血管性年龄相关性黄斑变性的患者被确定为转换候选者。然而，患者并未继续使用兰尼单抗进行治疗，而是从假想的切入点检查了视觉和解剖结局，而不是继续使用兰尼单抗治疗。设计3期HARBOR临床试验的事后分析。参加者如果患者接受了3个月的初始兰尼单抗剂量中的3个和6个月的初始兰尼单抗剂量中的5个，则进行了3个月和6个月的转换分析，分别满足以下所有条件：从基线获得5个字母或更少的增益，最佳矫正视力（BCVA）20/40或更差，以及视网膜中央或中央凹厚度等于或大于中央子区域的视网膜内或视网膜下液厚度。方法在第3和第6个月检查患者数据，以确定符合预定转换标准的患者。从符合转换标准的那一点开始，直到HARBOR的第6、12、18和24个月，检查最佳矫正视力和CFT，并将其与不符合转换标准的人进行比较。主要观察指标观察指标包括从达到转换标准的那一点（第3个月或第6个月）开始，随时间推移的平均BCVA和CFT变化。结果到第3个月和第6个月，分别只有1059例患者中的44例（4.2％）和769例患者中的37例（4.8％），符合假设切换的纳入标准。在第3个月达到转换标准的患者，从第3到12个月平均获得5.3个字母，从第3个月到第24个月获得2.7个字母。第6个月的转换者从第6到12个月平均获得1.6字母，从第6个月获得1.8字母。到24。两组在24个月内的CFT均显着降低。结论第3个月的假设切换者在继续最初的兰尼单抗治疗的同时实现了视力和解剖学方面的改善。第6个月的转换结果重复了已发表的抗VEGF转换研究中通常报告的结果：稳定的视力或正常的视力改善，以及持续的实质性解剖学改善。从第3个月到第24个月，有7个字母。从第6个月到第12个月，第6个月的转换者平均增加了1.6个字母；从第6个月到第24个月，平均增加了1.8个字母。两组在24个月内的CFT均显着降低。结论第3个月的假设切换者在继续最初的兰尼单抗治疗的同时实现了视力和解剖学方面的改善。第6个月的转换结果重复了已发表的抗VEGF转换研究中通常报告的结果：稳定的视力或正常的视力改善，以及持续的实质性解剖学改善。从第3个月到第24个月，有7个字母。从第6个月到第12个月，第6个月的转换者平均增加了1.6个字母；从第6个月到第24个月，平均增加了1.8个字母。两组在24个月内的CFT均显着降低。结论第3个月的假设切换者在继续最初的兰尼单抗治疗的同时实现了视力和解剖学改善。第6个月的转换结果重复了已发表的抗VEGF转换研究中通常报告的结果：稳定的视力或正常的视力改善，以及持续的实质性解剖学改善。结论第3个月的假设切换者在继续最初的兰尼单抗治疗的同时实现了视力和解剖学方面的改善。第6个月的转换结果重复了已发表的抗VEGF转换研究中通常报告的结果：稳定的视力或正常的视力改善，以及持续的实质性解剖学改善。结论第3个月的假设切换者在继续最初的兰尼单抗治疗的同时实现了视力和解剖学方面的改善。第6个月的转换结果重复了已发表的抗VEGF转换研究中通常报告的结果：稳定的视力或正常的视力改善，以及持续的实质性解剖学改善。