NCT03577899终止3 期
A Multicenter, Double-Masked, Randomized, Dose-Ranging Trial to Evaluate the Efficacy and Safety of Conbercept Intravitreal Injection in Subjects With Neovascular Age-Related Macular Degeneration (AMD) (PANDA-1)
Chengdu Kanghong Biotech Co., Ltd.187 个研究点 分布在 7 个国家目标入组 1,157 人开始时间: 2018年9月25日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 1,157
- 试验地点
- 187
- 主要终点
- Mean change from baseline in best corrected visual acuity (BCVA) at Week 36 in the study eye
研究概览
简要总结
The purpose of this clinical study is to evaluate the efficacy and safety of two different levels of conbercept intravitreal (IVT) injection as compared to the approved vascular endothelial growth factor (VEGF) antagonist active control, aflibercept intravitreal injection (2.0 mg/eye, Eylea®), in subjects with neovascular AMD.
详细描述
A multicenter, multinational, double-masked, parallel-group, dose-ranging, active-controlled, randomized trial, which will randomize approximately 1140 subjects in a ratio of 1:1:1 to receive IVT injections of 0.5 mg conbercept, 1.0 mg conbercept, or 2.0 mg aflibercept. The trial includes a screening period of less than or equal to 14 days, followed by a treatment period of 92 weeks (last assessment at 96 weeks) with primary efficacy analysis at 36 weeks.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women ≥ 50 years of age at the Screening visit;
- •Females must be at least 1 year postmenopausal, or surgically sterilized, or, if of childbearing potential, must have a negative pregnancy test at the Screening visit;
- •o Women of childbearing potential must agree to use a highly effective method of contraception throughout the study.
- •Have received no previous treatment for neovascular AMD, including laser photocoagulation and/or photodynamic therapy (PDT) and/or IVT VEGF antagonists (treatment naïve) and;
- •Have active subfoveal choroidal neovascularization (CNV) lesions secondary to AMD (including polypoidal choroidal vasculopathy (PCV)) evidenced by subfoveal fluorescein angiography (FA) leakage, or definite subfoveal fluid by SD-OCT in the study eye at Screening;
- •Have a ETDRS BCVA letter score of 78 to 25 in the study eye at Screening;
- •Are willing and able to sign the study written informed consent form (ICF).
排除标准
- •Have had any prior ocular or systemic treatment (investigational or approved) or surgery for the treatment of neovascular AMD in the study eye except dietary supplements or vitamins;
- •Have participated as a subject in any interventional clinical trial within one month (30 days) prior to Baseline visit;
- •Have a subretinal hemorrhage that is either 50% or more of the total lesion area, or blood is under the fovea and is one or more disc areas in size (greater than 2.5 mm2) in the study eye at Screening;
- •Have any retinal pigment epithelial tears or rips in the study eye at Screening or upon examination at Baseline;
- •Have any vitreous hemorrhage in the study eye upon examination at Baseline or history of vitreous hemorrhage within eight weeks prior to Screening;
- •Have any other cause of CNV;
- •Have had prior pars plana vitrectomy in the study eye;
- •Have presence of a full thickness macular hole at Screening or upon examination at Baseline or a history of a full thickness macular hole in the study eye;
- •Have prior trabeculectomy or other filtration surgery in the study eye;
- •Have uncontrolled glaucoma;
- •Have active intraocular inflammation in either eye at Screening or upon examination at Baseline or a history of uveitis in either eye;
- •Have aphakia or pseudophakia with absence of posterior capsule (unless it occurred as a result of yttrium aluminum garnet (YAG) posterior capsulotomy) in the study eye;
- •Significant media opacities, including cataract, in the study eye that, in the opinion of the Investigator, could require either medical or surgical intervention during the study period;
- •Have any use of long acting intraocular steroids, including implants, within six months prior to Day 1, Baseline;
- •Have any known allergy to povidone iodine or known serious allergy to the fluorescein sodium for injection in angiography;
- •Any history of known contraindications indicated in the Food and Drug Administration (FDA)-approved label for the active control;
- •If female, be pregnant (positive urine pregnancy test at Screening) or breastfeeding.
结局指标
主要结局
Mean change from baseline in best corrected visual acuity (BCVA) at Week 36 in the study eye
时间窗: Baseline to Week 36
BCVA was assessed by Early Treatment of Diabetic Retinopathy Study (ETDRS) method
次要结局
- Proportion of subjects maintaining vision (i.e., losing <15 ETDRS BCVA letters) from baseline to Week 36(Baseline to Week 36)
- Half-life (t1/2) of conbercept doses conducted in a subgroup of subjects, when feasible(Baseline to Week 96)
- Presence of anti-drug antibody of conbercept doses conducted in a subgroup of subjects, when feasible(Baseline to Week 96)
- Proportion of subjects gaining ≥15 ETDRS BCVA letters from baseline to Week 36(Baseline to Week 36)
- Number of participants with adverse events as measure of safety and tolerability(Baseline to Week 96)
- Mean change from baseline in central retinal thickness (µm) by spectral domain optical coherence tomography (SD-OCT) at Week 36(Baseline and Week 36)
- Proportion of subjects maintaining vision (i.e. losing <15 ETDRS BCVA letters) from baseline to Week 48(Baseline to Week 48)
- Blood concentration of conbercept doses conducted in a subgroup of subjects, when feasible(Baseline to Week 96)
- Mean change from baseline in ETDRS BCVA letter score at Week 96(Baseline and Week 96)
研究者
研究点 (187)
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