Böhni Sophie C, Bittner Mario, Howell Jeremy P, Bachmann Lucas M, Faes Livia, Schmid Martin K
Eye Clinic, Cantonal Hospital of Lucerne, Spitalstrasse, 6000, Lucerne 16, Switzerland.
Medignition Inc. Research Consultants, Zurich, Switzerland.
BMC Ophthalmol. 2015 Aug 20;15:109. doi: 10.1186/s12886-015-0101-4.
To identify differences between Ranibizumab and Aflibercept in treatment-naïve patients with neovascular age-related macular degeneration (nvAMD) in a real-life clinical setting.
We compared two groups of patients with a fairly similar prognosis either receiving Aflibercept or Ranibizumab within a pro re nata regimen for 1 year. Changes in visual acuity (letters) and central foveal thickness (CFT) and frequency of injections after completing the loading phase were evaluated using two separate multivariate mixed linear models.
When correcting for baseline differences between the Aflibercept (11 eyes) and Ranibizumab (16 eyes) group, there was neither divergence in visual acuity (-0.97 letters (95 % CI. -6.06-4.12); p = 0.709), nor a significant difference in the reduction of CFT (-25.16 μm, 95 % CI; (-78.01-27.68); p = 0.351) between the two groups 1 year after treatment initiation. Also, the number of injection did not differ (0.04 (95 % CI; -0.16-0.09); p = 0.565).
In contrast to health claims, treatment-naïve nvAMD, Ranibizumab and Aflibercept were equivalent in terms of functional and morphologic outcomes and number of injections when studied in real-life clinical practice.
在现实临床环境中,确定初治新生血管性年龄相关性黄斑变性(nvAMD)患者使用雷珠单抗和阿柏西普治疗的差异。
我们比较了两组预后相当相似的患者,一组接受阿柏西普,另一组接受雷珠单抗,按需给药方案治疗1年。使用两个独立的多变量混合线性模型评估视力(字母数)、中心凹厚度(CFT)的变化以及完成负荷期后的注射频率。
校正阿柏西普组(11只眼)和雷珠单抗组(16只眼)之间的基线差异后,治疗开始1年后,两组在视力方面没有差异(-0.97字母数(95%可信区间:-6.06 - 4.12);p = 0.709),CFT降低幅度也没有显著差异(-25.16μm,95%可信区间:(-78.01 - 27.68);p = 0.351)。此外,注射次数也没有差异(0.04(95%可信区间:-0.16 - 0.09);p = 0.565)。
与健康声明相反,在现实临床实践中研究时,初治nvAMD患者使用雷珠单抗和阿柏西普在功能和形态学结果以及注射次数方面是等效的。