Hyogo College of Medicine Hospital, Hyogo, Japan.
Bayer Yakuhin, Osaka, Japan.
Jpn J Ophthalmol. 2019 Nov;63(6):437-447. doi: 10.1007/s10384-019-00687-2. Epub 2019 Oct 31.
To evaluate vision-related quality of life (QoL) in wet age-related macular degeneration (wAMD) patients receiving intravitreal aflibercept (IVT-AFL).
Prospective, observational Japanese postmarketing surveillance study.
All decisions were made by the treating physician. QoL was assessed using the 25-item National Eye Institute-Visual Functioning Questionnaire (NEI-VFQ-25) composite score administered at baseline, 6 months, and 12 months (primary assessment). Secondary assessments included NEI-VFQ-25 subscale scores, resource use, and best-corrected visual acuity (BCVA; logarithm of the minimum angle of resolution [logMAR]).
In total, 576 patients (baseline), 555 patients (6 months), and 446 patients (12 months) were included. The mean (SD) number of IVT-AFL injections was 3.5 (1.2) at 6 months and 4.6 (2.2) at 12 months. The mean (SD) improvement from baseline in the NEI-VFQ-25 composite score was 3.1 (11.1) at 6 months and 2.7 (12.3) at 12 months (P < .0001). For the NEI-VFQ-25 subscale scores, the mean change was ≥ 4 (minimally important difference) for general vision, near vision, and mental health at 6 months, and for general vision and mental health at 12 months (all P < .0001). A significant improvement from baseline was found in mean BCVA (logMAR) at 6 months (-0.1) and 12 months (-0.1) (P < .0001). The mean change from baseline in the NEI-VFQ-25 scores was greatest in patients with improved BCVA (gain of ≤ -0.3 logMAR units or ≥ 15 letters) after treatment.
IVT-AFL was associated with significant improvements in QoL and visual acuity in Japanese patients with wAMD in a real-world setting.
评估接受玻璃体内注射阿柏西普(IVT-AFL)的湿性年龄相关性黄斑变性(wAMD)患者的视觉相关生活质量(QoL)。
前瞻性、观察性的日本上市后监测研究。
所有决策均由主治医生做出。在基线、6 个月和 12 个月(主要评估)时使用 25 项国家眼科研究所视觉功能问卷(NEI-VFQ-25)综合评分评估 QoL。次要评估包括 NEI-VFQ-25 子量表评分、资源利用和最佳矫正视力(BCVA;最小分辨角对数[logMAR])。
共有 576 名患者(基线)、555 名患者(6 个月)和 446 名患者(12 个月)纳入研究。6 个月时 IVT-AFL 注射的平均(SD)次数为 3.5(1.2),12 个月时为 4.6(2.2)。与基线相比,6 个月时 NEI-VFQ-25 综合评分的平均(SD)改善为 3.1(11.1),12 个月时为 2.7(12.3)(P<0.0001)。对于 NEI-VFQ-25 子量表评分,6 个月时,一般视力、近视力和心理健康的平均变化≥4(最小有意义差异),12 个月时一般视力和心理健康的平均变化≥4(均 P<0.0001)。6 个月时和 12 个月时 BCVA(logMAR)的平均变化均较基线显著改善(均 P<0.0001)。治疗后 BCVA(logMAR)改善(≤-0.3 logMAR 单位或≥15 个字母)的患者的 NEI-VFQ-25 评分基线变化最大。
在真实世界环境中,IVT-AFL 可显著改善日本 wAMD 患者的 QoL 和视力。