Kobayashi Yume, Maruyama-Inoue Maiko, Inoue Tatsuya, Yanagi Yasuo, Kadonosono Kazuaki
Department of Ophthalmology, Yokohama City University Medical Center, 57 Urafune-cho, Minami-ku, Yokohama, Kanagawa, 232-0024, Japan.
BMC Ophthalmol. 2025 Apr 14;25(1):207. doi: 10.1186/s12886-025-04049-0.
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.
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.
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).
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.
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。
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。
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）。
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。
