Nixon Donald R, Flinn Nicholas Ap
Trimed Eye Center, Barrie, ON, Canada.
Clin Ophthalmol. 2017 Apr 18;11:715-721. doi: 10.2147/OPTH.S131343. eCollection 2017.
This study evaluated visual function and anatomic and vision-related quality-of-life outcomes in recalcitrant neovascular age-related macular degeneration (AMD) subjects switched to aflibercept (Eylea) from ranibizumab (Lucentis).
In a single-center study conducted in Barrie, ON, 40 patients with persistent fluid despite previous ranibizumab treatment were switched to aflibercept with 3 consecutive monthly doses. Main outcome measure was mean change from baseline to week 12 in Pelli-Robson contrast sensitivity (CS). Secondary outcomes were mean change in best corrected visual acuity (BCVA), central retinal thickness (CRT), and National Eye Institute 25-Item Visual Function Questionnaire (NEI VFQ-25) score. A two-sided paired -test was used in the statistical data analysis to compare the means of continuous variables.
Forty-nine eyes (baseline visual acuity [VA] >6/120) were evaluated. Ranibizumab injections (mean ± standard deviation [SD] 28.2±22.1 [range 3-86]) were administered prior to treatment switch. Mean CS improved from 1.32 at baseline to 1.40 log units at week 12. VA was stable throughout. Mean CRT decreased from 354 µm at baseline to 332 µm at week 12 (-22 µm, =0.004). Twenty-six (65%) patients experienced an overall improvement in NEI VFQ-25 score. Interestingly, a correlation was observed between improvement in log CS and CRT change (=0.000046).
Contrast sensitivity improved statistically and significantly, and CRT decreased from baseline to week 12 after a switch to aflibercept from ranibizumab. Analysis of CS as an independent outcome end point in neovascular AMD treatment switch studies may provide a more complete understanding of visual response.
本研究评估了难治性新生血管性年龄相关性黄斑变性(AMD)患者从雷珠单抗(Lucentis)转换为阿柏西普(Eylea)后的视觉功能、解剖结构及与视力相关的生活质量结果。
在安大略省巴里市进行的一项单中心研究中,40例既往接受雷珠单抗治疗后仍有持续性积液的患者连续3个月每月接受一次阿柏西普治疗。主要观察指标是从基线到第12周佩利-罗布森对比敏感度(CS)的平均变化。次要观察指标是最佳矫正视力(BCVA)、视网膜中央厚度(CRT)和美国国立眼科研究所25项视觉功能问卷(NEI VFQ-25)评分的平均变化。在统计数据分析中使用双侧配对t检验来比较连续变量的均值。
评估了49只眼(基线视力[VA]>6/120)。在治疗转换前给予雷珠单抗注射(平均±标准差[SD]28.2±22.1[范围3-86])。平均CS从基线时的1.32提高到第12周时的1.40对数单位。VA在整个过程中保持稳定。平均CRT从基线时的354µm降至第12周时的332µm(-22µm,P=0.004)。26例(65%)患者的NEI VFQ-25评分总体改善。有趣的是,观察到对数CS改善与CRT变化之间存在相关性(P=0.000046)。
从雷珠单抗转换为阿柏西普后,对比敏感度在统计学上有显著改善,且从基线到第12周CRT降低。在新生血管性AMD治疗转换研究中,将CS作为独立的观察终点进行分析可能会更全面地了解视觉反应。