Silva, R., Berta, A., Larsen, M., Macfadden, W., Feller, C., Monés, J.
月一次 血管性 黄斑
摘要：目的：旨在评估来自TReat和extEND（TREND）研究的雷珠单抗0.5 mg治疗和扩展治疗（T＆E）方案与每月治疗一次方案治疗新生血管性年龄相关性黄斑变性（nAMD）患者的疗效和安全性。设计：一项为期 12个月的3b期视力（VA）评估者不知情，多中心，随机，介入研究。研究对象：650例患者。方法：将初治nAMD患者（年龄≥50岁）按1：1随机分组，接受雷珠单抗0.5mg T＆E（323例）与每月治疗一次方案（327例）。主要预后指标：主要指标是显示兰尼单抗0.5mg T＆E与每月方案的非劣效性，通过从基线至研究结束的最佳矫正VA（BCVA）变化进行评估。 次要指标包括从基线到研究结束的视网膜中央子区厚度（CSFT），治疗暴露和安全性变化。结果：总体而言，89.8％（T＆E方案）和90.2％（每月治疗一次方案）的患者完成了研究。两个治疗组之间的患者人口统计学和基线特征平衡良好。 T＆E方案不劣于每月治疗方案（P <0.001），最小均方和BCVA从基线6.2变化到研究结束时的8.1个字母。在两个治疗组中，大多数BCVA改善发生在头6个月，并一直维持到研究结束。 T＆E组和每月治疗一次组从基线至研究结束的平均CSFT变化分别为-169.2μm和-173.3μm。接受T＆E（8.7）和每月治疗一次方案（11.1）患者需要的注射次数较少，平均次数为8.9次和11.2次。治疗组之间的不良事件类型和发生率类似。结论：与每月治疗一次方案相比，在从基线到研究结束时VA改善上，雷珠单抗0.5 mgT＆E方案在统计学上具有非劣性和临床可比性。没有确定雷珠单抗的新安全性信号。
PURPOSE:To evaluate the efficacy and safety of ranibizumab 0.5 mg treat-and-extend (T&E) versus monthly regimens in patients with neovascular age-related macular degeneration (nAMD) from the TReat and extEND (TREND) study.DESIGN:A 12-month phase 3b visual acuity (VA) assessor-masked, multicenter, randomized, interventional study.PARTICIPANTS:Six hundred fifty patients.METHODS:Treatment-na ve nAMD patients (age, ≥50 years) were randomized 1:1 to receive either a ranibizumab 0.5 mg T&E (n = 323) or monthly (n = 327) regimen.MAIN OUTCOMES MEASURES:The primary objective was to show noninferiority of ranibizumab 0.5 mg T&E versus monthly regimen, as assessed by the change in best-corrected VA (BCVA) from baseline to the end of the study. Secondary objectives included change in retinal central subfield thickness (CSFT) from baseline to the end of study, treatment exposure, and safety.RESULTS:Overall, 89.8% (T&E) and 90.2% (monthly) of patients completed the study. Patient demographic and baseline characteristics were well balanced between the 2 treatment groups. The T&E regimen was noninferior (P < 0.001) to the monthly regimen, with a least squares mean BCVA change from baseline of 6.2 versus 8.1 letters to the end of study, respectively. In both treatment groups, most BCVA improvements occurred during the first 6 months and were maintained until the end of the study. The mean change in CSFT from baseline to the end of study was -169.2 μm and -173.3 μm in the T&E and monthly groups, respectively. Fewer injections were required in patients receiving the T&E (8.7) versus monthly (11.1) regimen, with mean number of postbaseline visits of 8.9 and 11.2, respectively. Types and rates of adverse events were comparable between the treatment groups.CONCLUSIONS:Ranibizumab 0.5 mg administered according to a T&E regimen was statistically noninferior and clinically comparable with a monthly regimen in improving VA from baseline to the end of study. No new safety signals for ranibizumab were identified.