PURPOSE

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.

DESIGN

A post hoc analysis of VIEW 1 and 2 randomized clinical trials.

METHODS

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.

RESULTS

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.

CONCLUSIONS

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.

中文翻译：

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新生血管性 AMD 中中央亚视野厚度变化与视力变化的相关性：VIEW 1 和 2 的事后分析

目的

确定接受抗血管内皮生长因子药物的新生血管性年龄相关性黄斑变性的中心亚视野厚度 (CST) 变化与最佳矫正视力 (BCVA) 变化之间的相关性。

设计

对 VIEW 1 和 2 随机临床试验的事后分析。

方法

该分析包括参与者随机接受雷珠单抗 0.5 mg 每 4 周 (Rq4)、玻璃体内阿柏西普注射 2 mg 每 4 周 (2q4) 和玻璃体内阿柏西普注射 2 mg 每 8 周 3 个月剂量 (2q8) 至第 52 周，然后根据需要（至少每 12 周）给药至第 96 周。使用 Pearson 相关系数确定 CST 和 BCVA 变化之间的关系。

结果

在 1815 只眼中，595 只被分配到 Rq4，613 只到 2q4，607 只到 2q8 组。第 12、52 和 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 Rq4 的 % CI，–0.24 至 –0.06)；2q4 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），以及 –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）对于 2q8。针对相关基线因素调整的线性回归分析显示，CST 变化占 BCVA 变化的 11%。CST 每减少 100 μm 与 第 52 周时减少 0.3 个字母（ P = .25）和 第 96 周时减少 0.14 个字母（ P = .69）相关。

结论

在 CST 和 BCVA 的变化与任何一种药物或方案之间的相关性较弱或没有相关性，这表明 CST 的变化不应用作新生血管性年龄相关性黄斑变性视力结果的替代指标。