Manchester Royal Eye Hospital, Central Manchester University Hospitals NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, United Kingdom; Centre for Ophthalmology & Vision Sciences, and Centre for Advanced Discovery & Experimental Therapeutics (CADET), Institute of Human Development, University of Manchester, Manchester, United Kingdom.
Centre for Biostatistics, Institute of Population Health, University of Manchester, Manchester, United Kingdom.
Ophthalmology. 2015 Jul;122(7):1348-55. doi: 10.1016/j.ophtha.2015.03.017. Epub 2015 Apr 17.
To evaluate the efficacy and safety of intravitreal bevacizumab (Avastin; Genentech, South San Francisco, CA) in patients with neovascular age-related macular degeneration (nAMD) using 2 different treatment regimens in which patients were assessed clinically at up to 12-week intervals.
Randomized, controlled, noninferiority trial.
A total of 331 patients with nAMD.
Patients were treated with 1.25 mg intravitreal bevacizumab and followed up to 92 weeks. They were randomized into 2 arms. All patients received 3 loading doses 4 weeks apart and thereafter were assessed every 12 weeks until the end of the study. One arm received a routine treatment at each 12-week assessment, and the other arm was treated at these assessments on an as-needed basis. After the loading doses, patients in either arm who showed signs of disease activity had an additional assessment after 6 weeks and at that visit had top-up treatments on an as-needed basis.
Mean best-corrected visual acuity (BCVA) at 92 weeks.
At 92 weeks, patients who had treatments every 12 weeks had superior BCVA to those treated on an as-needed basis every 12 weeks (P = 0.008), with the regular treatment arm gaining a mean BCVA of 5.5 letters and the as-needed treatment arm gaining 0.6 letters. The regular treatment arm of the study showed significantly improved outcomes with respect to 5-, 10-, and 15-letter changes in BCVA from baseline compared with the as-needed treatment arm, as well as superior reading speed. In patients who completed the study, up to but not including week 92, the mean number of treatments was 10.8 for the regular treatment arm and 9.1 for the as-needed treatment arm.
A treatment regimen with regular bevacizumab injections every 12 weeks after loading doses supplemented with as-needed top-up treatments produced a stable improvement in BCVA from baseline. The improvement in BCVA was broadly similar to that obtained in other studies using anti-vascular endothelial growth factor drugs with more frequent assessments and treatments.
评估玻璃体内注射贝伐单抗（Avastin；基因泰克，加利福尼亚州南旧金山）在使用 2 种不同治疗方案的患者中的疗效和安全性，这些方案中患者在长达 12 周的间隔内进行临床评估。
随机、对照、非劣效性试验。
共 331 例新生血管性年龄相关性黄斑变性（nAMD）患者。
患者接受 1.25mg 玻璃体内贝伐单抗治疗，随访 92 周。他们被随机分为 2 组。所有患者接受 4 周 1 次的 3 次负荷剂量，此后每 12 周评估 1 次，直至研究结束。1 组在每次 12 周评估时接受常规治疗，另一组在这些评估时按需治疗。在负荷剂量后，在疾病活动迹象的任何 1 组患者在 6 周后进行额外评估，在该就诊时按需进行补充治疗。
92 周时平均最佳矫正视力（BCVA）。
在 92 周时，每 12 周接受治疗的患者的 BCVA 优于每 12 周按需治疗的患者（P=0.008），常规治疗组的平均 BCVA 增加了 5.5 个字母，而按需治疗组仅增加了 0.6 个字母。与按需治疗组相比，研究中的常规治疗组在 5 个、10 个和 15 个字母的 BCVA 从基线的变化以及更好的阅读速度方面显示出显著改善的结果。在完成研究的患者中，直至但不包括第 92 周，常规治疗组的平均治疗次数为 10.8 次，按需治疗组为 9.1 次。
在负荷剂量后每 12 周进行常规贝伐单抗注射，并按需补充追加治疗的方案，可使基线时的 BCVA 稳定改善。BCVA 的改善与其他使用更频繁评估和治疗的抗血管内皮生长因子药物的研究中获得的改善大致相似。
