NCT04486963已完成2 期
A Randomized, Double-blind, Placebo-controlled, Ranibizumab Injected, Multicenter Phase II Clinical Study on the Efficacy and Safety of Sanhuangjingshimingwan in the Wet AMD(Qi and Yin Deficiency, Phlegm-blood Stasis Syndrome )Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 78
- 试验地点
- 6
- 主要终点
- The average number of reinjections
研究概览
简要总结
The study is to evaluate the efficacy and safety of Sanhuangjingshimingwan in Wet AMD.
详细描述
The study is to evaluate the efficacy and safety of Sanhuangjingshimingwan,give two times a day versus placebo in wAMD .The clinical phase of the study comprises a 6-months double-blind treatment period, resulting in 6.5-months overall duration of the study for each patient.
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
- Quadruple (Participant, Care Provider, Investigator, 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
- •All patients must meet the following criteria for entry into the trail:
- •Meet the diagnostic criteria for wAMD.
- •Meet the Traditional Chinese Medicine diagnostic criteria for Qi and Yin Deficiency, Phlegm-blood Stasis Syndrome.
- •Presence of choroidal neovascularization secondary to wAMD, and/or simple eye with blood, edema, leakage, hard exudation in or below the retina, and detachment of retinal pigment epithelium or neuroepithelium epithelium.
- •50 years≤Age≤80 years of either gender.
- •BCVA 25 - 78 ETDRS letters(0.06~0.6, inclusive).
- •Signed informed consent form.
排除标准
- •Subjects who meet any of the following criteria will be excluded from study entry:
- •Presence of pathological myopia,high myopia caused of secondary choroidal neovascularization, glaucoma, diabetic retinopathy, retinal arteriovenous obstruction, optic neuropathy (optic neuritis, atrophy, papillary edema), macular hole, acute phase of intraocular inflammation.
- •Only retinal pigment epithelium-retinal detachment.
- •The CNV area is more than 12 optic disk area (30mm2).
- •Subfoveal structural damage or fibrosis.
- •Subjects that have unclear refractive stroma(e.g.vitreous hemorrhage, cataracts) caused fundus observation difficulty or undergone vitrectomy.
- •Subjects that have presence of other causes of choroidal neovascularization.
- •Subjects that have participated in other study of treatment with study drug within the last 3 months before the screening.
- •Subjects that have treated with photodynamic therapy, external beam radiological therapy, argon laser photocoagulation in macular area, macular surgery, transpupillary thermotherapy, hormone to treat wAMD in any eye within the last 6 months before the screening.
- •Subjects that have undergone previous any eye surgery(except eyelid surgery).
- •Subjects that have intravitreal anti-VEGF injections in the past 3 months.
- •Subjects with history of fundus fluorescein and indocyanine green allergy.
- •Subjects that have any contraindications in the directions of ranibizumab(LUCENTIS)injection.
- •Subjects that have had severe heart disease in the last 6 months,such as congestive heart failure，unstable angina，acute coronary syndrome，myocardial infarction，Coronary revascularization，artery thrombosis, and ventricular arrhythmia that need treatment.
- •Subjects with uncontrolled hypertension（After antihypertension treatment SBP≥140mmHg、DBP≥90mmHg）.
- •PLT≤100×109/L; Coagulation function disorders;TBIL（Total Bilirubin）>1.5×UNL（Upper Limits of Normal）;ALT（Alanine Transaminase）>2.5×UNL or AST（Aspartate aminotransferase）>2.5×UNL;Cr（Creatinine）>1.5×UNL.
- •Subjects with uncontrolled disease history, such as serious mental, neurological, respiratory, immune, blood and other system diseases, malignant tumors and that not suitable for the study per the investigator's judgment.
研究组 & 干预措施
Sanhuangjingshimingwan Placebo group
Placebo Comparator
Sanhuangjingshimingwan placebo,12g/bag,1 bag,Bid.Anti VEGF injection will be injected monthly if needed.
干预措施: Sanhuangjingshimingwan Placebo (Drug)
Sanhuangjingshimingwan group
Experimental
Sanhuangjingshimingwan,12g/bag,1 bag,Bid.Anti VEGF injection will be injected monthly if needed.
干预措施: Sanhuangjingshimingwan (Drug)
结局指标
主要结局
The average number of reinjections
时间窗: at week 24
The subject is injected with Anti-VEGF（Vascular Endothelial Growth Factor） injection once 4 weeks if needed.Compare with the average shoot number of Anti-VEGF injections in both arms.
次要结局
- The percentage of subjects in both arms receiving reinjection of Anti-VEGF injection(at screening;at week 4;at week 8;at week 12;at week 16;at week 20;at week 24)
- The BCVA increasing >5, >10 and > 15 letters change from baseline(at screening;at week 4;at week 8;at week 12;at week 16;at week 20;at week 24)
- The BCVA decreasing<5, <10 and < 15 letters change form baseline(at screening;at week 4;at week 8;at week 12;at week 16;at week 20;at week 24)
- Change from Baseline in Central Retinal Thickness (CRT)(at screening;at week 4;at week 8;at week 12;at week 16;at week 20;at week 24)
- The average number of days between the second injection and baseline injection(at screening;at week 4;at week 8;at week 12;at week 16;at week 20;at week 24)
- Change from Baseline in leakage area(at week 24)
- The BCVA decreasing≥15, ≥30 letters change form baseline(at week 24)
- Change from Baseline in the number of polypoid choroidal vasculopathy(PCV) and Branching vascular network(BVN) area(at screening;at week 4;at week 8;at week 12;at week 16;at week 20;at week 24)
- Change from Baseline in Choroidal Neovascularization (CNV) area(at screening;at week 4;at week 8;at week 12;at week 16;at week 20;at week 24)
- Change from Baseline in TCM(Traditional Chinese Medicine) syndrome scores(at screening;at week 4;at week 8;at week 12;at week 16;at week 20;at week 24)
- Change from baseline in BCVA(at screening;at week 4;at week 8;at week 12;at week 16;at week 20;at week 24)
- Change from Baseline in the effective TCM syndrome scores(at screening;at week 4;at week 8;at week 12;at week 16;at week 20;at week 24)
研究者
研究点 (6)
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