Clinical Trials and Evaluation Unit, Bristol Trials Centre, Bristol Medical School, University of Bristol, Bristol, United Kingdom.
Department of Ophthalmology, University of Pennsylvania, Philadelphia.
JAMA Ophthalmol. 2020 Oct 1;138(10):1043-1051. doi: 10.1001/jamaophthalmol.2020.3001.
When initiating anti-vascular endothelial growth factor (VEGF) treatment for patients with neovascular age-related macular degeneration (nAMD), knowledge of prognostic factors is important for advising patients and guiding treatment. We hypothesized that eyes with greater fluctuation in retinal thickness over time have worse outcomes than eyes with less variation.
To investigate whether visual and anatomic outcomes in eyes with nAMD initiating anti-VEGF treatment are associated with fluctuations in retinal thickness.
DESIGN, SETTING, AND PARTICIPANTS: In this study using data from the Comparison of Age-Related Macular Degeneration Treatments Trials (CATT) and the Inhibition of VEGF in Age-Related Choroidal Neovascularization (IVAN) randomized clinical trial, people with previously untreated nAMD were included. Data were collected from February 2008 to November 2012, and data were analyzed from April 2017 to April 2020.
Foveal center point thicknesses (FCPTs) were extracted from 1165 study eyes from CATT and 566 study eyes from the IVAN trial, excluding those with 3 measurements or less. For each eye, the SD of FCPT was calculated. Eyes were grouped by FCPT SD quartile. Associations of FCPT SD quartile with outcomes were quantified at month 24 or the last available visit by linear or logistic regression, adjusting for baseline best-corrected visual acuity (BCVA) and randomized allocations to drug and treatment regimen, for BCVA, development of fibrosis, and development of macular atrophy.
Of the 1731 included patients, 1058 (61.1%) were female, and the mean (SD) age was 78.6 (7.4) years. The median (interquartile range) FCPT SD was 40.2 (27.1-61.2) in the IVAN cohort and 59.0 (38.3-89.4) in the CATT cohort. After adjustment for baseline BCVA and trial allocations, BCVA worsened significantly across the quartiles of FCPT SD; the difference between the first and fourth quartiles was -6.27 Early Treatment Diabetic Retinopathy Study letters (95% CI, -8.45 to -4.09). The risk of developing fibrosis and macular atrophy also increased across FCPT SD quartiles. Odds ratios ranged from 1.40 (95% CI, 1.03 to 1.91) for quartile 2 to 1.95 (95% CI, 1.42 to 2.68) for quartile 4 for fibrosis and from 1.32 (95% CI, 0.90 to 1.92) for quartile 2 to 2.10 (95% CI, 1.45 to 3.05) for quartile 4 for macular atrophy.
Greater variation in retinal thickness in eyes with nAMD during treatment with anti-VEGF was associated with worse BCVA and development of fibrosis and macular atrophy in these post hoc analyses, despite protocol-directed treatment frequency. Practitioners may want to consider variation in retinal thickness when advising patients about their prognosis.
当为患有新生血管性年龄相关性黄斑变性（nAMD）的患者启动抗血管内皮生长因子（VEGF）治疗时，了解预后因素对于为患者提供建议和指导治疗非常重要。我们假设视网膜厚度随时间的波动较大的眼睛比波动较小的眼睛的预后更差。
研究在开始接受抗 VEGF 治疗的 nAMD 眼中，视觉和解剖学结果是否与视网膜厚度的波动有关。
设计、地点和参与者：本研究使用了来自比较年龄相关性黄斑变性治疗试验（CATT）和抑制年龄相关性脉络膜新生血管化中的 VEGF（IVAN）随机临床试验的数据，纳入了以前未经治疗的 nAMD 患者。数据收集于 2008 年 2 月至 2012 年 11 月，数据分析于 2017 年 4 月至 2020 年 4 月进行。
从 CATT 的 1165 只研究眼中和 IVAN 试验的 566 只研究眼中提取了中心凹视网膜厚度（FCPT），排除了 3 次或更少测量的研究眼。对于每只眼，计算了 FCPT 的标准差（SD）。根据 FCPT SD 的四分位数将眼睛分组。通过线性或逻辑回归，在第 24 个月或最后一次可获得的随访时，对 FCPT SD 四分位数与结局之间的关联进行量化，调整了基线最佳矫正视力（BCVA）和药物和治疗方案的随机分配，用于 BCVA、纤维化的发展和黄斑萎缩的发展。
在纳入的 1731 名患者中，1058 名（61.1%）为女性，平均（SD）年龄为 78.6（7.4）岁。IVAN 队列的中位数（四分位距）FCPT SD 为 40.2（27.1-61.2），CATT 队列为 59.0（38.3-89.4）。在调整了基线 BCVA 和试验分配后，BCVA 在 FCPT SD 的四分位数中显著恶化；第一四分位和第四四分位之间的差异为-6.27 个早期治疗糖尿病视网膜病变研究字母（95%CI，-8.45 至-4.09）。纤维化和黄斑萎缩的风险也随着 FCPT SD 四分位数的增加而增加。比值比范围从第 2 四分位的 1.40（95%CI，1.03 至 1.91）到第 4 四分位的 1.95（95%CI，1.42 至 2.68），用于纤维化，从第 2 四分位的 1.32（95%CI，0.90 至 1.92）到第 4 四分位的 2.10（95%CI，1.45 至 3.05）用于黄斑萎缩。
在接受抗 VEGF 治疗的 nAMD 眼中，视网膜厚度的变化较大与这些后分析中 BCVA 下降以及纤维化和黄斑萎缩的发展有关，尽管有方案指导的治疗频率。从业者在为患者提供预后建议时可能需要考虑视网膜厚度的变化。
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