Differential Response to Anti-VEGF Regimens in Age-Related Macular Degeneration Patients with Early Persistent Retinal Fluid
Differential Response to Anti-VEGF Regimens in Age-Related Macular Degeneration Patients with Early Persistent Retinal Fluid
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DOI：
10.1016/j.ophtha.2016.05.016
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发表时间：
2016-09-01
期刊：
影响因子：
13.7
通讯作者：
Heier, Jeffrey S.
中科院分区：
文献类型：
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作者：
Jaffe, Glenn J.;Kaiser, Peter K.;Heier, Jeffrey S.
目的：比较玻璃体内注射阿柏西普或雷珠单抗药物类型和频率对新生血管性年龄相关性黄斑变性 (NVAMD) 和首次每月注射 3 次后早期持续性视网膜积液的眼睛的视力结果的影响。设计：对 VIEW 1 和 VIEW 2、2 项类似设计的随机 3 期试验中入组的眼睛进行事后分析。参与者：总共 来自 VIEW 1 和 VIEW 2 的 1815 只眼睛患有 NVAMD。 方法：分析包括 3 个治疗组中在基线和第 4、8 和 12 周已知体液状态的患者：雷珠单抗每 4 周 0.5 mg (Rq4) (n = 595)、玻璃体内阿柏西普注射 (IAI) 每 4 周 2 mg (2q4) (n = 613) 和 IAI 2每 8 周 毫克 (2q8) 3 个月注射后 (n = 607)。 主要结果指标：在 16 至 52 周期间，平均最佳矫正视力 (BCVA) 相对于基线的变化以及有或没有持续性液体（所有 4 次初次就诊时出现囊性视网膜内或视网膜下液体）的眼睛中增加 >= 15 个字母或丢失 >= 5 个字母的眼睛比例。还根据液体类型（视网膜内和视网膜下液体）评估持续性液体眼的视觉结果。结果：Rq4、2q4 和 2q8 组中持续性液体眼的比例分别为 29.4%、18.8% 和 20.3%。在这些眼睛中，与 Rq4 (P < 0.01) 和 2q8 (P < 0.05) 相比，2q4 从基线到第 52 周的平均 BCVA 增益更大，而与 Rq4 和 2q8 相似 (P = 0.294)。第 52 周时，与 Rq4 和 2q8 相比，增加 >= 15 个字母的眼睛比例相似 (31.5%-35.2%)，而使用 2q4 则损失 >= 5 个字母的眼睛较少（6.5% vs. 16.6% 和 16.2%）。无论液体类型如何，视觉结果的模式都是相似的。在没有持续性液体的眼睛中，各治疗组的 BCVA 变化相似。结论：对于早期持续性液体的患者，2q4 可能比 2q8 或 Rq4 提供额外的临床益处。 (C) 2016 年由美国眼科学会颁发。
Purpose: To compare the effect of intravitreal aflibercept or ranibizumab drug type and frequency on visual acuity outcomes in eyes with neovascular age-related macular degeneration (NVAMD) and early persistent retinal fluid after 3 initial monthly injections.Design: A post hoc analysis of eyes enrolled in VIEW 1 and VIEW 2, 2 similarly designed, randomized, phase 3 trials.Participants: A total of 1815 eyes with NVAMD from VIEW 1 and VIEW 2.Methods: Analyses included patients with known fluid status at baseline and weeks 4, 8, and 12 in 3 treatment groups: ranibizumab 0.5 mg every 4 weeks (Rq4) (n = 595), intravitreal aflibercept injection (IAI) 2 mg every 4 weeks (2q4) (n = 613), and IAI 2 mg every 8 weeks (2q8) after 3 monthly injections (n = 607).Main Outcome Measures: Mean best-corrected visual acuity (BCVA) change from baseline over weeks 16 to 52 and the proportion of eyes that gained >= 15 letters or lost >= 5 letters were evaluated in eyes with and without persistent fluid (cystic intraretinal or subretinal fluid at all 4 initial visits). Visual outcomes also were assessed in eyes with persistent fluid by fluid type (intraretinal and subretinal fluid).Results: The proportions of eyes with persistent fluid were 29.4%, 18.8%, and 20.3% in the Rq4, 2q4, and 2q8 groups, respectively. In these eyes, mean BCVA gain from baseline to week 52 was greater with 2q4 compared with Rq4 (P < 0.01) and 2q8 (P < 0.05), whereas it was similar with Rq4 and 2q8 (P = 0.294). At week 52, similar proportions of eyes gained >= 15 letters (31.5%-35.2%), whereas fewer eyes lost >= 5 letters with 2q4 compared with Rq4 and 2q8 (6.5% vs. 16.6% and 16.2%). The pattern of visual outcomes was similar regardless of fluid type. In eyes without persistent fluid, BCVA changes were similar across treatment groups.Conclusions: In patients with early persistent fluid, 2q4 may provide additional clinical benefit over 2q8 or Rq4. (C) 2016 by the American Academy of Ophthalmology.