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临床试验/JPRN-UMIN000004845
JPRN-UMIN000004845已完成未知

Effect of dose schedule using Ranibizumab and Verteporfin in Japanese Polypoidal Choroidal Vasculopathy Patients (Fuji-san study) - Dose schedule of verteporfin and ranibizumab in Japanese polypoidal choroidal vasculopathy patients

Fuji-san study group0 个研究点目标入组 84 人开始时间: 2011年1月8日最近更新:
适应症

试验速览

阶段
未知
状态
已完成
发起方
入组人数
84

研究概览

简要总结

The best-corrected visual acuity increased by a mean of 8.1 Early Treatment of Diabetic Retinopathy Study (ETDRS) letters in the initial PDT group and 8.8 ETDRS letters in the later PDT group, and there was a no significant difference (P = 0.59). The mean central retinal thickness decreased significantly in both groups but more so with combination therapy within the first 4 months; the difference was not significant at Month 12 (P = 0.30). The rate of eyes showing resolution of polypoidal lesions at 12 months was 62.1% in the initial PDT group and 54.8% in the later PDT group and again, there was no significant difference (P = 0.53). The mean number of additional IVR was 1.5 in initial PDT and 3.8 in later PDT; that of additional PDTs was 0.14 and 0.45, respectively, and they were significantly different (P < 0.001 and P = 0.013, respectively).

研究设计

研究类型
Interventional

入排标准

年龄范围
50years-old 至 ot applicable(—)
性别
Male

入选标准

  • 未提供

排除标准

  • 1.Histories of prior treatments for PCV 2.Hypersensitivity or allergy to fluorescein or indocyanine green (ICG), clinically significant drug allergy or known hypersensitivity to therapeutic or diagnostic protein products, or to any of the study drugs or their components 3.Patient with history of porphyria 4.Histories of which might affect the interpretation of the results of the study, or renders the patient at high risk from treatment complications 5.Presence of RPE tears, angioid streaks, macular fibrosis, pathologic myopia (-6 diopters or more) , central serous chorioretinopathy 6.Concomitant conditions/diseases in study eyes including uncontrolled glaucoma and active ocular inflammation 7.Intraocular surgery within 2 months 8.Presence of typical type 2 CNV

研究者

发起方
Fuji-san study group

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