珠穆朗玛峰II研究中息肉状脉络膜血管病变的6年随访结果：日本亚组分析
Six-year findings of polypoidal choroidal vasculopathy in the EVEREST II study: Japanese subgroup analysis.
作者信息
Yanagi Yasuo, Mori Ryusaburo, Teo Kelvin Yi Chong, Park Kyu-Hyung, Ngah Nor Fariza, Chen Shih-Jen, Ruamviboonsuk Paisan, Kondo Nagako, Lee Won Ki, Rajagopalan Rajesh, Obata Ryo, Wong Ian Y H, Chee Caroline, Terasaki Hiroko, Sekiryu Tetsuju, Chen Shih-Chou, Lai Timothy Y Y, Cheung Gemmy, Honda Shigeru
机构信息
Retina Research Group, Singapore Eye Research Institute, Singapore Eye-ACP, Duke-NUS Medical School, National University of Singapore, Singapore, Singapore.
Department of Ophthalmology and Micro-Technology, Yokohama City University, 4-57 Urahune-cho, Minami-ku, Yokohama, Kanagawa, 232-0024, Japan.
出版信息
Jpn J Ophthalmol. 2025 Jun 12. doi: 10.1007/s10384-025-01228-w.
PURPOSE
To evaluate long-term outcomes for polypoidal choroidal vasculopathy (PCV) in Japanese patients in the EVEREST II study.
STUDY DESIGN
A multicenter, cross-sectional study of the long-term outcomes of a cohort of patients originally treated with ranibizumab alone (monotherapy group) or in combination with photodynamic therapy PDT (combination group) in the EVEREST II study (ClinicalTrials.gov identifier, NCT01846273).
METHODS
Ninety participants from the six-year EVEREST II follow-up: 20 Japanese and 70 non-Japanese were included. Long-term changes in best-corrected visual acuity (BCVA) and central subfield thickness (CST) were reported in the Japanese compared to non-Japanese participants. Number of injections, types of anti-vascular endothelial growth factor (VEGF) agents used, and cases with equal visits and injections, indicating fixed dosing or treat-and-extend (TAE) administration were investigated. Outcomes were also compared between those who had verteporfin PDT during the six-year period (n=14) and those who did not (n=6).
RESULTS
The Japanese and non-Japanese participants had similar baseline characteristics. The mean age for Japanese participants was 76±4.47 years, with 25% being women. BCVA improved from baseline to year 2 in both groups (P < 0.05). At six years, BCVA was maintained in the Japanese (67.2 ETDRS letters) but decreased in the non-Japanese participants (from 68.8 to 53.5 letters). The Japanese participants received more injections than the non-Japanese (12.5 vs. 7.57, P=0.017). Aflibercept was the most frequently used anti-VEGF agent, and the number of fixed dosing or TAE administration was higher in the Japanese participants. No significant differences were found in functional and anatomical outcomes between those who received PDT and those who did not (all P > 0.05). However, non-PDT participants had numerically worse BCVA at the final visit.
CONCLUSIONS
This study highlights positive long-term outcomes for Japanese PCV patients and underscores the need for further research to validate these findings in broader patient populations.
目的
在EVEREST II研究中评估日本患者息肉样脉络膜血管病变（PCV）的长期预后。
研究设计
一项多中心横断面研究，对EVEREST II研究（ClinicalTrials.gov标识符，NCT01846273）中最初单独接受雷珠单抗治疗（单药治疗组）或联合光动力疗法（PDT）治疗（联合治疗组）的一组患者的长期预后进行研究。
方法
纳入了来自EVEREST II研究六年随访期的90名参与者：20名日本人和70名非日本人。报告了日本参与者与非日本参与者相比，最佳矫正视力（BCVA）和中心子野厚度（CST）的长期变化。调查了注射次数、使用的抗血管内皮生长因子（VEGF）药物类型，以及就诊和注射次数相同的病例，即固定剂量给药或治疗并延长（TAE）给药情况。还比较了在六年期间接受维替泊芬PDT治疗的患者（n = 14）和未接受治疗的患者（n = 6）的预后。
结果
日本和非日本参与者具有相似的基线特征。日本参与者的平均年龄为76±4.47岁，女性占25%。两组的BCVA从基线到第2年均有所改善（P < 0.05）。在六年时，日本参与者的BCVA得以维持（67.2 ETDRS字母），而非日本参与者的BCVA下降（从68.8降至53.5字母）。日本参与者比非日本参与者接受了更多的注射（12.5次对7.57次，P = 0.017）。阿柏西普是最常用的抗VEGF药物，日本参与者中固定剂量给药或TAE给药的次数更多。接受PDT治疗的患者与未接受治疗的患者在功能和解剖学预后方面未发现显著差异（所有P > 0.05）。然而，未接受PDT治疗的参与者在最后一次就诊时BCVA数值上更差。
结论
本研究突出了日本PCV患者积极的长期预后，并强调需要进一步研究以在更广泛的患者群体中验证这些发现。
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