Surgical Service, Veterans Affairs Boston Healthcare System, Jamaica Plain, MA, USA.
Eye (Lond). 2010 Nov;24(11):1708-15. doi: 10.1038/eye.2010.147. Epub 2010 Oct 1.
To report 1-year visual and anatomic outcomes of a prospective, double-masked randomised clinical trial comparing bevacizumab with ranibizumab for the treatment of age-related macular degeneration (AMD).
Patients who met inclusion criteria were randomised 2 : 1 to bevacizumab or ranibizumab. All subjects and investigators (except for the pharmacist responsible for study assignments) were masked to treatment arms. Visual acuity was taken on Early Treatment Diabetic Retinopathy Study chart. Patients were given either bevacizumab or ranibizumab every month for the first 3 months, followed by an optical coherence tomography-guided, variable-dosing treatment schedule. Main outcomes measured included visual acuity, foveal thickness, and total number of injections over the 1-year treatment period.
In total, 15 patients received bevacizumab and 7 patients received ranibizumab. The average pre-operative visual acuity was 34.9 letters in the bevacizumab group, and 32.7 letters in the ranibizumab group. At 1-year follow-up, mean vision was 42.5 letters in the bevacizumab group, and 39.0 letters in the ranibizumab group. Two-tailed t-test failed to showed statistical significance between the two groups (P=0.5). Patients in the bevacizumab group underwent an average of eight injections, whereas patients in the ranibizumab group underwent a mean of four injections (P=0.001).
The 1-year outcomes of a prospective, double-masked, randomised clinical trial comparing bevacizumab with ranibizumab failed to show a difference in visual and anatomic outcomes between the two treatments for choroidal neovascularisation in AMD. Total injections given over the treatment period were significantly different between the two groups. Further studies with larger sample sizes are warranted.
报告一项前瞻性、双盲、随机临床试验的 1 年视力和解剖结果,该试验比较了贝伐单抗与雷珠单抗治疗年龄相关性黄斑变性(AMD)。
符合纳入标准的患者按 2:1 随机分为贝伐单抗组或雷珠单抗组。所有患者和研究者(负责研究分配的药剂师除外)均对治疗组进行盲法。视力采用早期糖尿病视网膜病变研究图表进行测量。前 3 个月,所有患者每月接受贝伐单抗或雷珠单抗治疗,之后根据光学相干断层扫描指导进行可变剂量治疗方案。主要观察指标包括 1 年治疗期间的视力、中心凹厚度和总注射次数。
共有 15 例患者接受了贝伐单抗治疗,7 例患者接受了雷珠单抗治疗。贝伐单抗组术前平均视力为 34.9 个字母,雷珠单抗组为 32.7 个字母。在 1 年随访时,贝伐单抗组平均视力为 42.5 个字母,雷珠单抗组为 39.0 个字母。双尾 t 检验未显示两组之间有统计学意义(P=0.5)。贝伐单抗组患者平均接受 8 次注射,而雷珠单抗组患者平均接受 4 次注射(P=0.001)。
一项前瞻性、双盲、随机临床试验的 1 年结果显示,贝伐单抗与雷珠单抗治疗 AMD 脉络膜新生血管的视力和解剖结果无差异。两组治疗期间的总注射次数差异有统计学意义。需要进一步进行更大样本量的研究。