Department of Ophthalmology, Centro Hospitalar e Universitário de Coimbra (CHUC), Coimbra, Portugal; Institute for Biomedical Imaging and Life Sciences, Faculty of Medicine, University of Coimbra (IBILI-FMUC), Portugal; Association for Innovation and Biomedical Research on Light and Image (AIBILI), Coimbra, Portugal.
Department of Ophthalmology, Faculty of Medicine, Medical and Health Science Center, University of Debrecen, Debrecen, Hungary.
Ophthalmology. 2018 Jan;125(1):57-65. doi: 10.1016/j.ophtha.2017.07.014. Epub 2017 Oct 12.
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.
A 12-month phase 3b visual acuity (VA) assessor-masked, multicenter, randomized, interventional study.
Six hundred fifty patients.
Treatment-naïve 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.
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.
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.
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.
评估雷珠单抗 0.5mg 治疗-延伸（T&E）与每月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，该研究来自 TREat and extEND（TREND）研究。
一项为期 12 个月的视力评估盲法、多中心、随机、干预性 3b 期研究。
650 名患者。
未经治疗的 nAMD 患者（年龄≥50 岁）按 1:1 随机分为雷珠单抗 0.5mg T&E 组（n=323）或每月方案组（n=327）。
主要目标是通过从基线到研究结束时最佳矫正视力（BCVA）的变化来证明雷珠单抗 0.5mg T&E 与每月方案的非劣效性，这是评估的主要目标。次要观察指标包括从基线到研究结束时视网膜中央小凹厚度（CSFT）的变化、治疗暴露情况和安全性。
总体而言，89.8%（T&E）和 90.2%（每月）的患者完成了研究。两组患者的人口统计学和基线特征均均衡。T&E 方案与每月方案相比具有非劣效性（P<0.001），从基线到研究结束时的最小二乘平均 BCVA 变化分别为 6.2 个和 8.1 个字母。在两组治疗中，大多数 BCVA 改善发生在治疗的前 6 个月，并持续到研究结束。从基线到研究结束时 CSFT 的平均变化分别为 T&E 组和每月组的-169.2μm 和-173.3μm。接受 T&E 治疗的患者需要的注射次数更少（8.7）与每月方案（11.1）相比，平均随访次数分别为 8.9 和 11.2。治疗组之间的不良事件类型和发生率相似。
雷珠单抗 0.5mg 按 T&E 方案给药，在从基线到研究结束时改善视力方面具有统计学上的非劣效性，与每月方案相当。未发现雷珠单抗的新安全性信号。
