Lotery A, Griner R, Ferreira A, Milnes F, Dugel P
Eye Unit, University Hospital Southampton NHS Foundation Trust, Southampton, UK.
Clinical and Experimental Sciences, Faculty of Medicine, University of Southampton, Southampton, UK.
Eye (Lond). 2017 Dec;31(12):1697-1706. doi: 10.1038/eye.2017.143. Epub 2017 Jul 21.
PurposeTo examine 12-month real-world visual acuity outcomes and treatment patterns in neovascular age-related macular degeneration (nAMD) eyes, including those with pigment epithelial detachment (PED), receiving ranibizumab or aflibercept.Patients and methodsElectronic medical records were used to identify ranibizumab or aflibercept-treated nAMD eyes with 12 months follow-up from first prescription. The primary objective was to compare mean change in visual acuity (VA) between index and month 12, in eyes treated with ranibizumab and aflibercept to assess the non-inferiority of ranibizumab vs aflibercept using a -5 letter non-inferiority margin. The number of injections and non-injection visits during follow-up were key secondary objectives.ResultsA total of 3350 ranibizumab and 4300 aflibercept treatment-naive eyes were included. At month 12, mean change from index in VA letter score was -0.30 for ranibizumab and -0.19 for aflibercept (P=0.81). The adjusted difference of mean change was -0.14 (-0.79 to 0.51) (P=0.67) (generalized estimating equations method) confirming the non-inferiority of ranibizumab. Eyes received a similar number of injections during follow-up. The mean (±SD) number of ranibizumab and aflibercept injections were 6.70 (±2.54) and 7.00 (±2.40), respectively (P<0.0001). In PED eyes, the mean (±SD) change between baseline to month 12 was 1.25 (±11.3) for ranibizumab and -0.39 (±13.3) for aflibercept (adjusted between-group difference 1.80 (-0.71 to 4.30; P=0.16)) achieved with a mean (±SD) 7.85 (±2.68) ranibizumab and 7.47 (±2.45) aflibercept injections, (P=0.11).ConclusionsRanibizumab and aflibercept treatment yielded comparable VA outcomes in nAMD eyes, including those with PED, with similar treatment patterns over 12 months in real-world clinical practice.
目的
研究接受雷珠单抗或阿柏西普治疗的新生血管性年龄相关性黄斑变性（nAMD）眼，包括伴有色素上皮脱离（PED）的眼睛，12个月的真实世界视力结果和治疗模式。
患者和方法
使用电子病历识别从首次处方开始随访12个月的接受雷珠单抗或阿柏西普治疗的nAMD眼。主要目的是比较接受雷珠单抗和阿柏西普治疗的眼睛在基线和第12个月时视力（VA）的平均变化，使用-5字母的非劣效性界值评估雷珠单抗相对于阿柏西普的非劣效性。随访期间的注射次数和非注射就诊次数是关键次要目标。
结果
共纳入3350只初治雷珠单抗眼和4300只初治阿柏西普眼。在第12个月时，雷珠单抗组VA字母评分相对于基线的平均变化为-0.30，阿柏西普组为-0.19（P = 0.81）。平均变化的校正差异为-0.14（-0.79至0.51）（P = 0.67）（广义估计方程法），证实了雷珠单抗的非劣效性。随访期间两组眼睛接受的注射次数相似。雷珠单抗和阿柏西普的平均（±标准差）注射次数分别为6.70（±2.54）和7.00（±2.40）（P<0.0001）。在PED眼中，雷珠单抗组从基线到第12个月的平均（±标准差）变化为1.25（±11.3），阿柏西普组为-0.39（±13.3）（组间校正差异1.80（-0.71至4.30；P = 0.16）），雷珠单抗组和阿柏西普组的平均（±标准差）注射次数分别为7.85（±2.68）和7.47（±2.45）（P = 0.11）。
结论
在真实世界临床实践中，雷珠单抗和阿柏西普治疗在nAMD眼（包括伴有PED的眼睛）中产生了相当的视力结果，且12个月内治疗模式相似。
