Purpose

The aim of this study was to determine associations between early residual fluid (ERF)−free status and improved long-term visual outcomes.

Design

This was a retrospective clinical cohort study from a post hoc analysis of 2 phase III clinical trials’ data.

Methods

Independent of treatment allocation, patients from the multicenter, prospective, randomized, double-masked HAWK and HARRIER trials who received either brolucizumab 6 mg or aflibercept 2 mg were split into 2 cohorts depending on the presence or absence of ERF at week 12. In addition, similar analyses were performed on the presence or absence of early residual intraretinal fluid (IRF) and subretinal fluid (SRF) at week 12. The 2 groups, ERF-free (n = 1051) and ERF (n = 366) patients were compared. Changes from baseline in best corrected visual acuity (BCVA) and central subfield thickness (CST) were determined.

Results

From week 12 to 96, patients who were ERF free had greater least squares (LS) mean increases from baseline for BCVA and CST compared to ERF patients. Greater LS mean differences in BCVA from week 12 to 96 were noted between ERF-free and ERF patients. A greater proportion of patients in the ERF-free cohort reported a ≥5, ≥10, or ≥15 letter improvement, and a higher proportion reported BCVA ≥70 letters from baseline to week 96 compared to patients with fluid.

Conclusions

Improvements in visual outcomes in ERF-free patients were greater than in ERF patients occurring as early as 4 weeks (week 12) after the last loading dose and continued to week 96. Therefore, ERF status may be a useful indicator of anti−vascular endothelial growth factor treatment response.

中文翻译：

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早期无残留液体状态和长期 BCVA 结果：HAWK 和 HARRIER 汇总数据的治疗不可知、事后分析

目的

本研究的目的是确定早期无残留液体 (ERF) 状态与改善的长期视力结果之间的关联。

设计

这是一项回顾性临床队列研究，来自对 2 项 III 期临床试验数据的事后分析。

方法

独立于治疗分配，来自多中心、前瞻性、随机、双盲 HAWK 和 HARRIER 试验的患者接受 brolucizumab 6 mg 或 aflibercept 2 mg 根据第 12 周时是否存在 ERF 分为 2 个队列。此外，对第 12 周时是否存在早期残留视网膜内液 (IRF) 和视网膜下液 (SRF) 进行了类似的分析。比较了 2 组无 ERF (n = 1051) 和 ERF (n = 366) 患者. 确定最佳矫正视力 (BCVA) 和中心子视野厚度 (CST) 与基线的变化。

结果

从第 12 周到第 96 周，与 ERF 患者相比，无 ERF 的患者 BCVA 和 CST 的最小二乘 (LS) 平均增加幅度更大。从第 12 周到第 96 周，在没有 ERF 的患者和 ERF 患者之间注意到更大的 LS 平均 BCVA 差异。与有液体的患者相比，在无 ERF 队列中，更大比例的患者报告了≥5、≥10 或 ≥15 个字母的改善，并且更高比例的患者报告了从基线到第 96 周的 BCVA ≥70 个字母。

结论

早在最后一次负荷剂量后 4 周（第 12 周）并持续到第 96 周，无 ERF 患者的视觉结果改善大于 ERF 患者。因此，ERF 状态可能是抗血管内皮的有用指标生长因子治疗反应。