Anegondi Neha, Steffen Verena, Sadda Srinivas R, Schmitz-Valckenberg Steffen, Tufail Adnan, Csaky Karl, Lad Eleonora M, Kaiser Peter K, Ferrara Daniela, Chakravarthy Usha
Genentech, Inc., South San Francisco, California.
Doheny Image Reading Center, Doheny Eye Institute, Pasadena, California; Department of Ophthalmology, University of California - Los Angeles, California.
Ophthalmology. 2025 Apr;132(4):420-430. doi: 10.1016/j.ophtha.2024.11.017. Epub 2024 Nov 23.
To assess the correlation of lesion growth rate and baseline factors, including foveal involvement and focality, on visual loss as measured by best-corrected visual acuity (BCVA) in patients with geographic atrophy (GA) secondary to age-related macular degeneration (AMD).
Retrospective analysis of the lampalizumab phase 3 (NCT02247479 and NCT02247531) and prospective observational (NCT02479386) trials.
Patients with bilateral GA.
Monthly BCVA and fundus autofluorescence (FAF) at baseline and every 6 months for 2 years were analyzed. Baseline GA area from FAF images was correlated to baseline BCVA and change in BCVA. The lesion growth rate was calculated as the slope of a linear fit from all available GA area measurements of a patient. The association between GA growth rate quartiles and BCVA changes was assessed, subgrouped by GA foveal involvement or focality. Time-to-event analysis for BCVA loss of ≥5, ≥10, and ≥15 letters was performed. A Cox regression model adjusted for baseline factors was performed on these outcomes. Kaplan-Meier curves are provided for each baseline factor and GA growth rate.
Correlations of baseline BCVA, GA area, and growth rate with change in BCVA, and time to ≥5, ≥10, and ≥15-letter loss by foveal involvement or focality.
Best-corrected visual acuity and GA area at baseline did not correlate with BCVA change at any visit. Geographic atrophy growth rate showed a weak correlation with BCVA loss, which increased over time. The 2 highest GA growth rate quartiles had accelerated BCVA loss in eyes with subfoveal, unifocal lesions. Approximately 75%, 50%, and 25% of study eyes experienced a ≥5-, ≥10-, and ≥15-letter loss by 2 years, respectively.
Best-corrected visual acuity and GA area at baseline did not correlate with BCVA loss, but faster GA growth rates appeared to be associated with faster BCVA loss. Geographic atrophy foveal involvement and focality correlated with the rate of BCVA loss with subfoveal lesions at high risk of vision loss over time, especially when the GA lesion was unifocal.
FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found after the references.
评估年龄相关性黄斑变性(AMD)继发地图样萎缩(GA)患者中,病变生长速率与包括黄斑中心凹受累情况和病灶范围在内的基线因素,与采用最佳矫正视力(BCVA)测量的视力丧失之间的相关性。
对lampalizumab 3期试验(NCT02247479和NCT02247531)以及前瞻性观察性试验(NCT02479386)进行回顾性分析。
双侧GA患者。
分析基线时以及之后2年每6个月的每月BCVA和眼底自发荧光(FAF)。来自FAF图像的基线GA面积与基线BCVA以及BCVA的变化相关。病变生长速率计算为患者所有可用GA面积测量值的线性拟合斜率。评估GA生长速率四分位数与BCVA变化之间的关联,并按GA黄斑中心凹受累情况或病灶范围进行亚组分析。对BCVA损失≥5、≥10和≥15字母进行事件发生时间分析。对这些结果进行调整了基线因素的Cox回归模型分析。为每个基线因素和GA生长速率提供Kaplan-Meier曲线。
基线BCVA、GA面积和生长速率与BCVA变化的相关性,以及按黄斑中心凹受累情况或病灶范围分析BCVA损失≥5、≥10和≥15字母的时间。
基线时的最佳矫正视力和GA面积与任何一次随访时的BCVA变化均无相关性。地图样萎缩生长速率与BCVA损失呈弱相关性,且随时间增加。GA生长速率最高的两个四分位数在黄斑中心凹下、单灶性病变的眼中BCVA损失加速。到2年时,分别约有75%、50%和25%的研究眼经历了BCVA损失≥5、≥10和≥15字母。
基线时的最佳矫正视力和GA面积与BCVA损失无相关性,但更快的GA生长速率似乎与更快的BCVA损失相关。地图样萎缩黄斑中心凹受累情况和病灶范围与BCVA损失速率相关,黄斑中心凹下病变随着时间推移有较高的视力丧失风险,尤其是当GA病变为单灶性时。
在参考文献之后可能会找到专有或商业披露信息。