Comparison of the Effects of Photodynamic Therapy, Intravitreal Ranibizumab and Combination for Polypoidal Choroidal Vasculopathy Under 1+PRN Regimen
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Best corrected visual acuity
研究概览
简要总结
The aim of this study is to compare the outcomes of different treatment methods including photodynamic therapy (PDT), intravitreal ranibizumab injection (IVR) and combination therapy under the "1+PRN" treatment regimen for polypoidal choroidal vasculopathy (PCV) and find the optimal treatment for PCV.
详细描述
The optimal treatment for PCV is still under debate. Little knowledge is known about the treatment effect of "1+pro re nata(PRN)" treatment regimen for PCV. The aim of this study is to compare the outcomes of different treatment methods including PDT, IVR and combination therapy under the "1+PRN" treatment regimen for PCV.
The study is the first prospective randomized controlled trial about different treatment methods on PCV under "1+PRN" treatment regimen. The null hypothesis of the study is that combination therapy may be the optimal treatment method for PCV. The primary outcome measures is the Best-corrected visual acuity (BCVA) of the participants at 1 year after treatment. Besides, the slit-lamp examination, tonometry, funduscopy, and OCT, FFA, ICGA examinations will also be compared between different groups to find the optimal treatment for PCV.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •active macula-involved polypoidal lesions evidenced by ICGA;
- •greatest linear dimension of 5400 μm or less assessed by ICGA;
- •follow-up of at least 12 months.
排除标准
- •any other ocular disease, such as ocular trauma, glaucoma, uveitis, diabetic retinopathy, angioid streaks, pathologic myopia, or presumed ocular histoplasmosis syndrome;
- •any systemic contraindication to the PDT, IVR, sodium fluorescein, or indocyanine green dyes;
- •any severe uncontrolled systemic disease, such as uncontrolled hypertention, coronary heart disease, liver failure, or kidney failure.
研究组 & 干预措施
photodynamic therapy
Participants will be given the standard verteporfin photodynamic therapy at baseline followed by additional standard verteporfin PDT as needed (every three months)(namely 1+PRN regimen).
干预措施: verteporfin (Drug)
photodynamic therapy
Participants will be given the standard verteporfin photodynamic therapy at baseline followed by additional standard verteporfin PDT as needed (every three months)(namely 1+PRN regimen).
干预措施: verteporfin and ranibizumab (Drug)
intravitreal ranibizumab
Participants will receive the intravitreal ranibizumab treatment (0.05mg) at baseline and additional intravitreal ranibizumab will be given to the participants when necessary (every month) (namely 1+PRN regimen).
干预措施: verteporfin (Drug)
intravitreal ranibizumab
Participants will receive the intravitreal ranibizumab treatment (0.05mg) at baseline and additional intravitreal ranibizumab will be given to the participants when necessary (every month) (namely 1+PRN regimen).
干预措施: verteporfin and ranibizumab (Drug)
combination therapy of PDT and IVR
Participants will be given the standard verteporfin photodynamic therapy followed by intravitreal ranibizumab (0.05mg) 72h after the standard verteporfin PDT treatment at baseline. Additional verteporfin photodynamic therapy and intravitreal ranibizumab (0.05mg) will be given to the participants when necessary (every month)(namely 1+PRN regimen).
干预措施: verteporfin (Drug)
combination therapy of PDT and IVR
Participants will be given the standard verteporfin photodynamic therapy followed by intravitreal ranibizumab (0.05mg) 72h after the standard verteporfin PDT treatment at baseline. Additional verteporfin photodynamic therapy and intravitreal ranibizumab (0.05mg) will be given to the participants when necessary (every month)(namely 1+PRN regimen).
干预措施: verteporfin and ranibizumab (Drug)
结局指标
主要结局
Best corrected visual acuity
时间窗: 12 months
the best corrected visual acuity is the Primary Outcome Measure
次要结局
未报告次要终点
研究者
Jin Chen-jin
Professor
Sun Yat-sen University