Oshima Yuji, Kimoto Kenichi, Yoshida Noriko, Fujisawa Kimihiko, Sonoda Shozo, Kubota Toshiaki, Murata Toshinori, Sakamoto Taiji, Yoshida Shigeo, Sonoda Koh-Hei, Ishibashi Tatsuro
Department of Ophthalmology, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
Ophthalmologica. 2017;238(3):163-171. doi: 10.1159/000477448. Epub 2017 Jul 12.
To evaluate 1-year outcomes of intravitreal injections of aflibercept (IVA) in Japanese polypoidal choroidal vasculopathy (PCV) patients.
In this prospective, open-label, single-arm multicenter clinical trial, treatment-naïve PCV patients received IVA (2.0 mg) every 2 months, after 3 initial monthly doses. The primary endpoint assessed was the proportion of patients maintaining baseline best-corrected visual acuity (BCVA) at 1 year.
Fifty eyes with PCV were included in the study. BCVA was maintained or improved in 97.6% of the patients. Mean logMAR BCVA at baseline was 0.33, and had improved to 0.12 logMAR 1 year after the initiation of aflibercept treatment (p < 0.001). Mean central foveal thickness decreased from 356 to 239 μm (p < 0.001). Complete regression of polypoidal lesions was seen in 72.5% after 1 year of treatment.
One year of IVA resulted in stabilization of BCVA and anatomical improvement in Japanese PCV patients.
评估玻璃体内注射阿柏西普（IVA）对日本息肉样脉络膜血管病变（PCV）患者的1年疗效。
在这项前瞻性、开放标签、单臂多中心临床试验中，初治PCV患者在最初每月注射3剂后，每2个月接受一次IVA（2.0毫克）注射。评估的主要终点是1年时维持基线最佳矫正视力（BCVA）的患者比例。
该研究纳入了50只患有PCV的眼睛。97.6%的患者BCVA得以维持或改善。基线时平均logMAR BCVA为0.33，在开始阿柏西普治疗1年后改善至0.12 logMAR（p < 0.001）。平均中心凹厚度从356μm降至239μm（p < 0.001）。治疗1年后，72.5%的息肉样病变完全消退。
1年的IVA治疗可使日本PCV患者的BCVA稳定，并在解剖结构上得到改善。
