Japanese age-related macular degeneration trial: 1-year results of photodynamic therapy with verteporfin in Japanese patients with subfoveal choroidal neovascularization secondary to age-related macular degeneration
Japanese age-related macular degeneration trial: 1-year results of photodynamic therapy with verteporfin in Japanese patients with subfoveal choroidal neovascularization secondary to age-related macular degeneration
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DOI：
10.1016/s0002-9394(03)00576-2
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发表时间：
2003-12-01
影响因子：
4.2
通讯作者：
Strong, A
中科院分区：
文献类型：
--
作者：
Tano, Y;Ohji, M;Strong, A
目得：目的：探讨维替泊芬（Visudyne）治疗日本老年性黄斑变性（AMD）患者的疗效和安全性。设计：开放标签、多中心、前瞻性、非对照研究。研究人群为年龄至少50岁的患者，最佳矫正视力为20/40至20/200（含），荧光素血管造影记录了继发于AMD的中心凹下、含经典脉络膜新生血管（CNV）和最大线性尺寸小于或等于55，400 μ m的病变。对于干预，患者静脉注射维替泊芬，然后在输注开始后15分钟进行轻度给药。如果在血管造影上观察到CNV渗漏，则每3个月给予额外治疗，直至第9个月。主要结果的措施是经典CNV的进展超出了基线insure.RESULTS面积病变的百分比：60，4例患者在5个中心，61例患者完成了研究。试验期间给予的治疗次数为3次。在12个月检查时，12例患者（19%; 95%置信区间：11%-31%）有典型CNV进展，而32例（50%）和49例（77%）患者分别无典型或隐匿性CNV渗漏。从基线至第12个月，中位视力评分（近似Snellen等效值）从50. 0（20/100）-56. 5（20/80（+2））个字母增加。14例患者（22%）出现视力障碍，包括2例患者（3%）出现被视为严重不良事件的急性视力下降，1例患者（2%）出现输注。背部疼痛相关无光敏反应reported.CONCLUSIONS：维替泊芬治疗这些日本患者的黄斑中心凹下CNV似乎有相似或更好的血管造影和视觉效果，观察到在高加索患者，具有相同的安全性，支持其在日本患者中使用。(C)2003年，Elsevier Inc. All rights reserved.
PURPOSE: To determine the effect and safety of verteporfin therapy (Visudyne) in Japanese age related macular degeneration (AMD) patients.DESIGN: Open-label, multicenter, prospective, noncontrolled study.METHODS: The setting was five university hospitals in Japan. The study population was patients at least 50 years old, with best,corrected visual acuity of 20/40 to 20/200 inclusive and fluorescein angiography documenting subfoveal, classic-containing choroidal neovascularization (CNV) secondary to AMD and a lesion of greatest linear dimension less than or equal to 5 5,400 mum. For the intervention, patients received verteporfin intravenously followed by light administration 15 minutes after the infusion start. Additional treatment was given every 3 months through month 9 if leakage from CNV was observed on angiogram. The main outcome measure was percentage of lesions with progression of classic CNV beyond the area of the baseline lesion.RESULTS: Sixty,four patients were enrolled at five centers, and 61 patients completed the study. The methan number of treatments given during the trial was three. At the 12-month examination, 12 patients (19%; 95% confidence interval: 11%-31%) had progression of classic CNV whereas 32 (50%) and 49 (77%) patients had no leakage from classic or occult CNV, respectively. The median visual acuity score (approximate Snellen equivalent) from baseline to month 12 increased from 50.0 (20/100)-56.5 (20/80(+2)) letters. Fourteen patients (22%) had visual disturbances, including two patients (3%) with acute vision decrease considered as serious adverse events and one patient (2%) with infusion. related back pain. No photosensitivity reactions were reported.CONCLUSIONS: Verteporfin therapy for subfoveal CNV in these Japanese patients appeared to have a similar or better angiographic and vision effect as that observed in Caucasian patients, with the same safety profile, supporting its use in Japanese patients. (C) 2003 by Elsevier Inc. All rights reserved.