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布罗鲁单抗治疗新生血管性年龄相关性黄斑变性患者的三年视力预后

Three-year visual outcomes after brolucizumab in patients with neovascular age-related macular degeneration.

作者信息

Kobayashi Yume, Maruyama-Inoue Maiko, Inoue Tatsuya, Yanagi Yasuo, Kadonosono Kazuaki

机构信息

Department of Ophthalmology, Yokohama City University Medical Center, 57 Urafune-cho, Minami-ku, Yokohama, Kanagawa, 232-0024, Japan.

出版信息

BMC Ophthalmol. 2025 Apr 14;25(1):207. doi: 10.1186/s12886-025-04049-0.

Abstract

BACKGROUND

The purpose of this study is to investigate the 3-year outcomes of intravitreal brolucizumab and determine the factors that affect the visual acuity (VA) in patients with neovascular age-related macular degeneration.

METHODS

All received three consecutive, monthly, induction brolucizumab injections (6.0 mg/0.05 ml) and fixed-dose every 2-or-3-month treatment for 12 months, after which a pro re nata (PRN) or treat-and-extend (TAE) regimen began. Best-corrected VAs (BCVAs) on a Landolt C eye chart were compared before and 4, 12, and 36 months after initial treatment. Factors affecting VA improvements and morphologic characteristics associated with VA at 36 months were determined.

RESULTS

Fifty-nine eyes were assessed at 36 months. The mean logMAR BCVAs at baseline and 4, 12, and 36 months after the initial injection were 0.37 ± 0.39, 0.34 ± 0.48, 0.30 ± 0.47, and 0.36 ± 0.51 in the PRN group and 0.31 ± 0.28, 0.22 ± 0.27, 0.18 ± 0.28, and 0.20 ± 0.31 in the TAE group, respectively. In the PRN group, post-injection BCVA did not improve significantly compared with baseline throughout 36 months (p = 0.999, p = 0.814, and p = 0.999 at 4, 12, and 36 months, respectively). In the TAE group, the post-injection BCVA at 12 and 36 months improved significantly compared with baseline (p = 0.006 and p = 0.032, respectively). The baseline BCVA, central foveal thickness (CFT) and TAE regimen were associated with improved VA (p < 0.05 for all). Eyes with subretinal fluid (SRF) at 36 months had significantly better VA (p = 0.019).

CONCLUSION

The TAE regimen achieved better visual outcomes at 3 years. Residual SRF should be tolerated during the maintenance phase if the change of CFT was little compared to the previous image.

摘要

背景

本研究旨在调查玻璃体内注射布罗芦izumab的3年疗效,并确定影响新生血管性年龄相关性黄斑变性患者视力(VA)的因素。

方法

所有患者均接受连续三个月每月一次的初始布罗芦izumab注射(6.0mg/0.05ml),并每2或3个月固定剂量治疗12个月,之后开始按需(PRN)或治疗并延长(TAE)方案。在初始治疗前以及治疗后4、12和36个月,比较Landolt C视力表上的最佳矫正视力(BCVA)。确定影响VA改善的因素以及与36个月时VA相关的形态学特征。

结果

在36个月时评估了59只眼。PRN组在基线、初始注射后4、12和36个月时的平均logMAR BCVA分别为0.37±0.39、0.34±0.48、0.30±0.47和0.36±0.51,TAE组分别为0.31±0.28、0.22±0.27、0.18±0.28和0.20±0.31。在PRN组中,整个36个月内注射后BCVA与基线相比均未显著改善(4、12和36个月时p分别为0.999、0.814和0.999)。在TAE组中,12和36个月时注射后BCVA与基线相比显著改善(分别为p=0.006和p=0.032)。基线BCVA、中心凹厚度(CFT)和TAE方案与VA改善相关(所有p<0.05)。36个月时有视网膜下液(SRF)的眼的VA明显更好(p=0.019)。

结论

TAE方案在3年时取得了更好的视觉效果。如果与之前图像相比CFT变化不大,则在维持阶段应容忍残留的SRF。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2070/11998395/268925aee74c/12886_2025_4049_Fig1_HTML.jpg

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