NCT02857517Unknown2 期
Intravitreal Conbercept for Idiopathic Choroidal Neovascularization
Jiao Mingfei1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2016年6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
- 50
- 试验地点
- 1
- 主要终点
- visual acuity(Snellen chart)
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of intravitreal anti-vascular endothelial growth factor (anti-VEGF) therapy as primary treatment for ICNV.
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
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient who give voluntary signed informed consent
- •Patient affiliated with the Tianjin Medical University Eye Hospital or similar
- •Patient with ICNV with active primary subfoveal, retrofoveal or juxtafoveal lesions that affect the fovea as evidenced by angiography (fluorescein and/or indocyanin green) and/or SD-OCT in the studied eye
- •Patient willing, committed and able to return for all clinic visits and complete all study-related procedures
排除标准
- •Pregnant women
- •Sexually active men or women of childbearing potential who are unwilling to practice adequate contraception during the study
- •Patient who is protected adults according to the terms of the law (French public health laws)
- •Involvement in another clinical trial (studied eye and/or the other eye)
- •Patient with non-ICNV, especially:
- •High myopia defined as refraction ≥ - 6 diopters
- •Other curative treatment of ICNV in the studied eye during the last 3 months before the first intravitreal injection: anti-VEGF therapy, juxta- or extra-foveal macular laser, photodynamic therapy, surgery, external radiotherapy, transpupillary thermotherapy ...
- •Medical history of retrofoveal focal macular laser photocoagulation in the studied eye
- •Subretinal haemorrhage reaching the fovea centre, with a size > 50% of the lesion area
- •Fibrosis or retrofoveal retinal atrophy in the studied eye
- •Retinal pigment epithelial tear reaching the macula in the studied eye
- •Medical history of intravitreal medical device in the studied eye
- •Medical history of auto-immune or idiopathic uveitis
- •Proved diabetic retinopathy
- •Intra-ocular pressure ≥ 25 mmHg despite two topical hypotonic treatments
- •Aphakia or lack of lens capsule (not removed by YAG laser) in the studied eye
- •Arterial hypertension that is not controlled by an appropriate treatment
- •Previous or actual treatment with systemic administration of anti-VEGF therapy
- •Known hypersensitivity to aflibercept, or another drug composite of the medicinal product used; allergy to fluorescein, indocyanin green, anaesthetic eye drops
- •Active or suspected ocular or peri-ocular infection
- •Serious active intra-ocular inflammation in the studied eye
- •Medical history of intra-ocular surgery within 28 days before the first injection in the studied eye
- •Any illness or ocular condition that would require an intra-ocular surgery in the studied eye within 12 months after the inclusion
- •Follow up not possible during 12 months
研究组 & 干预措施
intravitreal 0.05ml conbercept for ICNV
Experimental
0.05ml conbercept ,1 injection with PRN
干预措施: conbercept (Drug)
结局指标
主要结局
visual acuity(Snellen chart)
时间窗: Change from Baseline visual acuity at 1 year after injection
visual acuity
时间窗: Change from Baseline visual acuity at eight weeks after injection
次要结局
- macular central fovea thickness(OCT)(Change from Baseline macular central fovea thickness at 1 year after injection)
- macular central fovea thickness(Change from Baseline macular central fovea thickness at four weeks after injection)
研究者
Jiao Mingfei
Principal Investigator
Tianjin Medical University Eye Hospital
研究点 (1)
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