Department of Ophthalmology, Graduate School of Medical Sciences, Kyushu University, 3-1-1 Maidashi, Higashi-ku, Fukuoka, 812-8582, Japan.
Department of Ophthalmology, Kurume University School of Medicine, Fukuoka, Japan.
BMC Ophthalmol. 2021 Jan 23;21(1):58. doi: 10.1186/s12886-021-01816-7.
To evaluate the correlation between visual acuity improvement and vision-related QOL after ranibizumab treatment in Japanese patients with AMD.
In this one-year prospective, interventional, open-label, multicenter study involving four sites, patients with neovascular AMD were enrolled and observed for 12 months. Treatment-naïve patients received 0.5 mg ranibizumab as needed after three initial monthly doses. The best corrected visual acuity (BCVA) and central macular thickness (CMT) were measured at every visit. Evaluations with the 25-item National Eye Institute Visual Function Questionnaire (NEI-VFQ-25) and patient satisfaction questionnaire were performed at baseline and 3 and 12 months after initial treatment. The primary endpoint was change in BCVA and QOL 3 months after ranibizumab treatment. QOL outcomes were also assessed in the better and poor BVCA subgroups.
The study enrolled 100 patients. The mean logMAR BCVA after treatment improved significantly from 0.43 to 0.30 at 3 months (p< 0.0001), and 0.28 at 12 months (p< 0.0001). The mean NEI-VFQ-25 composite scores improved from 79.48 to 84.13 at 3 months (p< 0.0001), and 86.0 at 12 months (p< 0.0001). The 3 and 12-month changes in NEI-VFQ-25 score and BCVA showed significant correlation. In the poor baseline visual acuity group (decimal BCVA ≤0.5), there was a significant correlation between the changes in the NEI-VFQ-25 score and BCVA (p=0.02) but not in the better baseline visual acuity group (decimal BCVA > 0.6, p=0.1) at 3 months. There were no significant differences in the satisfaction questionnaire score from baseline to at 3 months (p=0.54) and 12 months (p=0.23). The average CMT improved significantly from 340 to 264 μm at 3 months (p< 0.0001) and to 268 μm at 12 months (p< 0.0001).
Intravitreal ranibizumab treatment resulted in improvement in visual acuity, anatomical change, and visual function change in Japanese AMD patients. Significant improvement was seen in patient visual function, and this was correlated with changes in VA, except immediately after loading dose treatment in patients with higher baseline VA. The patients' satisfaction with the treatment remained unchanged during the study period.
This study is registered at UMIN Clinical Trials Registry ( UMIN000012013 ). Registered October 10, 2013, as prospective study.
评估雷珠单抗治疗日本 AMD 患者后视力改善与与视觉相关生活质量（QOL）之间的相关性。
这是一项为期一年的前瞻性、干预性、开放性、多中心研究，涉及四个地点，共纳入了 100 名患有新生血管性 AMD 的患者，观察时间为 12 个月。治疗初接受三次每月剂量的初始治疗后，未经治疗的患者按需接受 0.5mg 雷珠单抗治疗。每次就诊时均测量最佳矫正视力（BCVA）和中心黄斑厚度（CMT）。在基线和初始治疗后 3 个月和 12 个月进行 25 项国立眼科研究所视觉功能问卷（NEI-VFQ-25）和患者满意度问卷评估。主要终点是治疗后 3 个月 BCVA 和 QOL 的变化。在更好和较差 BCVA 亚组中也评估了 QOL 结果。
该研究纳入了 100 名患者。治疗后平均 logMAR BCVA 在 3 个月时显著改善（从 0.43 提高到 0.30，p<0.0001），在 12 个月时进一步改善（从 0.28 提高到 0.30，p<0.0001）。平均 NEI-VFQ-25 综合评分在 3 个月时从 79.48 提高到 84.13（p<0.0001），在 12 个月时提高到 86.0（p<0.0001）。3 个月和 12 个月时 NEI-VFQ-25 评分和 BCVA 的变化呈显著相关性。在基线视力较差（十进制 BCVA≤0.5）的患者中，NEI-VFQ-25 评分的变化与 BCVA 之间存在显著相关性（p=0.02），而在基线视力较好（十进制 BCVA>0.6，p=0.1）的患者中则无显著相关性。在 3 个月（p=0.54）和 12 个月（p=0.23）时，患者满意度问卷评分与基线相比均无显著差异。
玻璃体内注射雷珠单抗治疗可改善日本 AMD 患者的视力、解剖结构和视觉功能。患者的视觉功能有显著改善，这与 VA 的变化有关，除了基线 VA 较高的患者在初始负荷剂量治疗后立即出现变化。在研究期间，患者对治疗的满意度保持不变。
本研究在 UMIN 临床试验注册（UMIN000012013）中注册。2013 年 10 月 10 日作为前瞻性研究进行注册。
