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临床试验/NCT01019668
NCT01019668已完成不适用

Central Serous Chorioretinopathy Treated by Modified Photodynamic Therapy

Shin Kong Wu Ho-Su Memorial Hospital1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2008年11月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
24
试验地点
1
主要终点
Effectiveness of both modification for the treatment of chronic CSCR Fluorescent leakage as regards to BCVA OCT changes

研究概览

简要总结

The purpose of this study is to evaluate the effectiveness as well as the detrimental influence of half-dose and half-fluence modification of verteporfin photodynamic therapy (PDT) for the treatment of prolonged unresolved central serous chorioretinopathy (CSCR).

详细描述

Purpose:

to evaluate the effectiveness as well as the detrimental influence of half-dose and half-fluence modification of verteporfin PDT for the treatment of prolonged unresolved Central Serous Chorioretinopathy (CSCR).

Study Design and Patient Recruitment:

This study was a prospective, randomized, consecutive, open-labeled, comparative interventional case series. Patients with symptomatic acute or chronic CSC of 3 weeks or more duration were recruited. Patients were offered treatment if they had worsening of symptoms or no subjective improvement since the onset of the CSC. Inclusion criteria included 1) patients with best-corrected visual acuity (BCVA) of 20/400 or better; 2) presence of subretinal fluid (SRF) and/or serous pigment epithelial detachment (PED) involving the fovea on optical coherence tomography (OCT); 3) presence of active angiographic leakage in fluorescein angiography (FA) caused by CSC but not CNV or other diseases; and 4) abnormal dilated choroidal vasculature and other features in ICGA consistent with the diagnosis of CSC. Patients who received previous PDT or focal thermal laser photocoagulation for the treatment of CSC or had evidence of CNV, polypoidal choroidal vasculopathy, or other maculopathy on clinical examination, FA, or ICGA were excluded. Informed consent was obtained from all subjects. 12 patients in each group were planned to recruit in each group.

Modified Photodynamic Therapy with Half Dosage:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with best-corrected visual acuity (BCVA) of 20/200 or better
  • Presence of subretinal fluid (SRF) and/or serous pigment epithelial detachment (PED) involving the fovea on optical coherence tomography (OCT)
  • Presence of active angiographic leakage in fluorescein angiography (FA) caused by CSC but not CNV or other diseases
  • Abnormal dilated choroidal vasculature and other features in ICGA consistent with the diagnosis of CSC.

排除标准

  • Patients who received previous PDT or focal thermal laser photocoagulation for the treatment of CSC.
  • Patients had evidence of CNV, polypoidal choroidal vasculopathy, or other maculopathy on clinical examination, FA, or ICGA

研究组 & 干预措施

verteporfin PDT, half-dose

Active Comparator

use different modification of verteporfin PDT to treat prolonged unresolved central serous chorioretinopathy

干预措施: Verteporfin PDT, half-dose (Drug)

verteporfin PDT, half-dose

Active Comparator

use different modification of verteporfin PDT to treat prolonged unresolved central serous chorioretinopathy

干预措施: verteporfin PDT, half-fluence (Drug)

verteporfin PDT, half-fluence

Active Comparator

use different modification of verteporfin PDT to treat prolonged unresolved central serous chorioretinopathy

干预措施: Verteporfin PDT, half-dose (Drug)

verteporfin PDT, half-fluence

Active Comparator

use different modification of verteporfin PDT to treat prolonged unresolved central serous chorioretinopathy

干预措施: verteporfin PDT, half-fluence (Drug)

结局指标

主要结局

Effectiveness of both modification for the treatment of chronic CSCR Fluorescent leakage as regards to BCVA OCT changes

时间窗: within 6 months

次要结局

  • Detrimental influence on choroidal perfusion Represented by the decrease of fluorescent intensity In ICGA(within 6 months)

研究者

申办方类型
Other

研究点 (1)

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