NCT02098720Unknown2 期
An Open, Non-randomize, Single-center, Safety and Efficacy Study of Conbercept in Patients With Very Low Vision Secondary to Wet Age-related Macular Degeneration
Chengdu Kanghong Biotech Co., Ltd.1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2011年12月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- percentage of patients with best corrected visual acuity (BCVA ) ≥19 letters gain
研究概览
简要总结
This study is designed to evaluate the effect of Conbercept therapy on visual acuity and anatomic outcomes and safety observed in subjects with very low vision secondary to wet age-related macular degeneration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Patients give fully informed consent and are willing and able to comply with all study procedures.
- •In the study eye:
- •There are primary or recurrent subfoveal or parafoveal active choroidal neovascularization (CNV) lesions secondary to wAMD.
- •The criterion of active CNV should meet at least one of following three conditions :
- •fresh bleeding;
- •neurosensory detachment showed on optical coherence tomography(OCT);
- •leakage showed on fundus fluorescein angiography (FFA).
- •BCVA in study eye < 19 letters (approximately 20/400 Snellen equivalent).
排除标准
- •Past or existing non-exudative AMD in study eye decided by investigator that have affected macular detection or central vision;
- •Subretinal hemorrhage in study eye and bleeding area ≥6 disc areas;
- •History of vitreous hemorrhage within last month;
- •The maximum diameter of scar and fibrosis area ≥500μm at subfoveal in study eye;
- •Photodynamic therapy (PDT) or drug treatment of CNV within last 6 months in study eye, or anti-vascular endothelial growth factor (VEGF) therapy in fellow eye within last month;
- •History of glaucoma in study eye;
- •Aphakia (excluding artificial lens) in the study eye.
研究组 & 干预措施
Conbercept
Experimental
Subjects will receive Conbercept injections at a dose of 0.5 mg/eye, once a month for first 3 months. In the next 3 months, the investigator will decide whether repeat injections are needed based on the monthly assessment results.
干预措施: Conbercept (Drug)
结局指标
主要结局
percentage of patients with best corrected visual acuity (BCVA ) ≥19 letters gain
时间窗: 6-month
次要结局
- mean change in BCVA from baseline(6-month)
- change from baseline of macular area thickness and other anatomy results(6-month)
- safety of Conbercept therapy(6-month)
研究者
研究点 (1)
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