Nanegrungsunk Onnisa, Gu Sophie Z, Bressler Susan B, Du Weiming, Amer Fouad, Moini Hadi, Bressler Neil M
From the Retina Division, Department of Ophthalmology, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA (O.N., S.B.B., N.M.B); Retina Division, Department of Ophthalmology, Chiang Mai University, Chiang Mai, Thailand (O.N.).
Johns Hopkins University School of Medicine, Baltimore, Maryland, USA (S.Z.G.).
Am J Ophthalmol. 2022 Jun;238:97-102. doi: 10.1016/j.ajo.2021.11.020. Epub 2021 Nov 27.
Determine correlation between change in central subfield thickness (CST) and change in best-corrected visual acuity (BCVA) in neovascular age-related macular degeneration receiving anti-vascular endothelial growth factor agents.
A post hoc analysis of VIEW 1 and 2 randomized clinical trials.
This analysis included participants randomized to ranibizumab 0.5 mg every 4 weeks (Rq4), intravitreal aflibercept injection 2 mg every 4 weeks (2q4), and intravitreal aflibercept injection 2 mg every 8 weeks after 3 monthly doses (2q8) to week 52, followed by capped as-needed (at least every 12 weeks) dosing to week 96. Relationship between changes in CST and BCVA was determined using Pearson correlation coefficient.
Of 1815 eyes, 595 were assigned to the Rq4, 613 to 2q4, and 607 to 2q8 arms. Correlations (95% confidence intervals [CI]) at weeks 12, 52, and 96 were -0.08 (95% CI, -0.17 to 0.00), -0.05 (95% CI, -0.14 to 0.04), and -0.15 (95% CI, -0.24 to -0.06) for Rq4; -0.13 (95% CI, -0.21 to -0.04), -0.06 (95% CI, -0.14 to 0.03) and -0.04 (95% CI, -0.13 to 0.05) for 2q4, and -0.04 (95% CI, -0.12 to 0.05), -0.01 (95% CI, -0.09 to 0.08), and -0.01 (95% CI, -0.10 to 0.09) for 2q8. Linear regression analysis adjusted for relevant baseline factors showed CST changes accounted for 11% of BCVA changes. Every 100 μm decrease in CST was associated with a 0.3 letter decrease (P = .25) at week 52 and a 0.14 letter decrease (P = .69) at week 96.
Weak or no correlation was found between changes in CST and BCVA with either agent or regimen, suggesting changes in CST should not be used as a surrogate for visual acuity outcomes in neovascular age-related macular degeneration.
确定接受抗血管内皮生长因子药物治疗的新生血管性年龄相关性黄斑变性患者的中心子野厚度(CST)变化与最佳矫正视力(BCVA)变化之间的相关性。
对VIEW 1和2随机临床试验的事后分析。
该分析纳入了随机接受每4周注射0.5 mg雷珠单抗(Rq4)、每4周玻璃体内注射2 mg阿柏西普(2q4)以及在3次每月剂量后每8周玻璃体内注射2 mg阿柏西普(2q8)直至第52周,随后根据需要(至少每12周一次)进行限量给药直至第96周的参与者。使用Pearson相关系数确定CST变化与BCVA变化之间的关系。
在1815只眼中,595只被分配至Rq4组,613只被分配至2q4组,607只被分配至2q8组。Rq4组在第12周、第52周和第96周的相关性(95%置信区间[CI])分别为-0.08(95%CI,-0.17至0.00)、-0.05(95%CI,-0.14至0.04)和-0.15(95%CI,-0.24至-0.06);2q4组分别为-0.13(95%CI,-0.21至-0.04)、-0.06(95%CI,-0.14至0.03)和-0.04(95%CI,-0.13至0.05);2q8组分别为-0.04(95%CI,-0.12至0.05)、-0.01(95%CI,-0.09至0.08)和-0.01(95%CI,-0.10至0.09)。针对相关基线因素进行调整的线性回归分析显示,CST变化占BCVA变化的11%。在第52周,CST每降低100μm与视力下降0.3个字母相关(P = 0.25),在第96周与视力下降0.14个字母相关(P = 0.69)。
使用任何一种药物或治疗方案时,均未发现CST变化与BCVA变化之间存在强相关性或无相关性,这表明在新生血管性年龄相关性黄斑变性中,CST变化不应被用作视力结果的替代指标。