Double-dose Ranibizumab for Polypoidal Choroidal Vasculopathy: A Prospective Randomized Multicenter Study
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 5
- 试验地点
- 4
- 主要终点
- Number of participants who have at least 1 polyp resolution
研究概览
简要总结
The purpose of this study is to determine whether double-dose Ranibizumab are effective to regress the polyps and benefit to the visual outcome in the polypoidal choroidal vasculopathy (PCV).
详细描述
Recently, it's reported that intravitreal high dose Lucentis®（Ranibizumab） could benefit to both regression of the polyps and the relief of macular edema in PCV patients. Since it was a single arm prospective study with a relatively small sample size, randomized clinical trials were needed to confirm the efficacy of high dose Ranibizumab in PCV treatment. In this study, the investigator will compare the efficacy of double-dose (1mg, 3+prn) Raibizumab with regular dose (0.5mg, 3+prn) for PCV treatment.
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
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 50 years and ≤80;
- •Active PCV confirmed by ICGA+FFA (Indocyanine green angiography + fundus fluorescein angiography);
- •At least one distinguishable polyp was shown in ICGA;
- •BCVA between 24 to 73 letters with ETDRS chart (Early Treatment of Diabetic Retinopathty Study);
- •The greatest linear dimension of the lesion <5400μm.
排除标准
- •Previously received treatment of laser retina photocoagulation, transpupillary thermotherapy, pneumatic displacement of subretinal blood or any investigational treatment;
- •Previous photodynamic therapy or anti-Vegf treatment within 6 months in study eye
- •Previously received treatment of photodynamic treatment within 1 month, or any anti-vascular endothelial growth factor (VEGF) intraocular injection in 3 months in the fellow eye;
- •Combine of current vitreous hemorrhage or extensive subretinal hemorrhage (lesion area >30mm2);
- •A history of angioid streaks, presumed ocular histoplasmosis syndrome or pathologic myopia;
- •Experienced retinal pigmental epithelium (RPE) tear, retinal detachment, macular hole or uncontrolled glaucoma;
- •Undergone intraocular surgery (except uncomplicated cataract extraction with intraocular lens implantation);
- •Cataract extraction with intraocular lens implantation within 60 days;
- •Combine of cataract that could require medical or surgical intervention during 12 months;
- •Combine of diabetes mellitus and have poor glucose control (Haemoglobin A1c (HbA1c) >8%);
- •Combine of hypertension and have poor blood pressure control (blood pressure ≥140/95 mmHg after regular antihypertensive drugs treatment);
- •History of myocardial infarction or cerebral infarction in last 6 months;
- •During gestation period or lactation period;
- •Combine of confirmed systemic autoimmune disease or any uncontrollable clinical conditions (e.g. HIV, malignant tumor, active hepatitis, severe systemic disease, diseases need immediately surgical treatment).
研究组 & 干预措施
double-dose
double-dose
Lucentis® (Raibizumab), 1mg, 3+prn
干预措施: Lucentis® (Raibizumab) double-dose (Drug)
regular-dose
regular-dose
Lucentis® (Raibizumab), 0.5mg, 3+prn
干预措施: Lucentis® (Raibizumab) regular-dose (Drug)
结局指标
主要结局
Number of participants who have at least 1 polyp resolution
时间窗: 6 months
Number of participants who have at least 1 polyp resolution, assessed by Indocyanine angiography (ICGA) between baseline and Month 6
次要结局
- change of best corrected visual acuity(BCVA)(Baseline to 6 months)
- change of central foveal thickness(Baseline to 6 months)
- Injection frequency(Baseline to 6 months)
- Safety analysis: number of adverse event(6 months)
研究者
Lin Lu
MD, PhD，Zhongshan Ophthalmic Center
Sun Yat-sen University