NCT01574430已完成4 期
A Randomized, Double-masked, Multicenter, Controlled Study of Photodynamic Therapy in Patients With Central Serous Chorioretinopathy
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 131
- 试验地点
- 1
- 主要终点
- Change from baseline in BCVA
研究概览
简要总结
The purpose of this study is to determine the safety and efficacy of PDT at 30% verteporfin dose in the treatment of CSC.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with CSC
- •patients signed the ICF
- •patients with course of CSC less than 6 months
- •patients did not undertake any treatment for CSC
排除标准
- •patients with porphyria
- •patients allergic to verteporfin
- •pregnant or nursing women
- •poor patients compliance
- •sever liver dysfunction
- •dioptric media opacities which make it difficult to exam fundus
研究组 & 干预措施
30% dose PDT
Experimental
patients in this group was given 30% verteporfin dose PDT
干预措施: PDT (Procedure)
50% dose PDT
Active Comparator
patients in this group was given 50% verteporfin dose PDT
干预措施: PDT (Procedure)
结局指标
主要结局
Change from baseline in BCVA
时间窗: 1 week,2 weeks,3 weeks,1 month,3months, 6 months, 1 year
次要结局
- The incidence rate of adverse event(1 week,2 weeks,3 weeks,1 month,3months, 6 months, 1 year)
- Leakage at RPE level in FA(1 week)
- Change from baseline in central retinal thickness(1 week,2 weeks,3 weeks,1 month,3months, 6 months, 1 year)
研究者
Mingwei Zhao
Dr.
Peking University People's Hospital
研究点 (1)
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