NCT01809236Unknown2 期
An Open Label, Single Arm Clinical Study of Intravitreal Injection of Conbercept in Patients With Maculae Edema Secondary to Retinal Vein Occlusion (the FALCON Study)
Chengdu Kanghong Biotech Co., Ltd.2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2012年5月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Mean change from baseline in BCVA
研究概览
简要总结
This is a Phase II, single arm, open label clinical trial. 60 RVO patients (including 30 BRVO and 30 CRVO, respectively) are enrolled in the study. The study included a fixed treatment period (3 months) and a PRN period (6 months). In the fixed treatment period patients will receive 3 consecutive monthly intravitreal of 0.5 mg Conbercept. In the PRN period, patients are monthly visited and retreatment will be needed according to the retreatment criteria pre-specified.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability and willingness to provide signed Informed Consent Form.
- •Age ≥ 18, both male and female。
- •Ocular Inclusion Criterion (Study Eye):
- •Diagnosis of Foveal center-involved macular edema due to RVO (both CRVO and BRVO) within 6 months.
- •Best corrected visual acuity (BCVA) letter score in the study eye of ≤ 73（Snellen equivalents 20/40）.
- •Central retinal thickness by OCT in the study eye ≥ 320 μm.
排除标准
- •Brisk afferent pupillary defect.
- •History of any anti-VEGF treatment in the study and/or system within 6 months before enrollment, and/or in the fellow eye within 3 month.
- •History of intraocular and/or peri-ocular corticosteroid use in the study eye within 3 months, and/or history of use steroids systemic (p.o., i.m., i.v.) within 1 month.
- •Any active infection involving the ocular including blepharitis, infectious conjunctivitis, keratitis, scleritis, endophthalmitis in either eye.
- •Any inflammatory cells detected in the anterior chamber and/or vitreous in the study eye.
- •Presence of non-RVO disease, in the opinion of the investigator, might cause macular edema, such as AMD (wet or dry), diabetes retinopathy, uveitis etc.
- •Neovascular change in the study eye and/or neovascularization of the iris or neovascular glaucoma in study eye at baseline.
- •Patients with substantial cataract that, in the opinion of the investigator, is likely to be decreasing visual acuity by equal or more than 3 lines or medicine or surgery treatment are needed in the study eye within 4 months.
- •Patients diagnosed with systemic immune diseases and any uncontrolled clinical disease.
- •Pregnant or nursing women.
- •Patients need to exclude in the opinion of investigator.
结局指标
主要结局
Mean change from baseline in BCVA
时间窗: 3-month
次要结局
- Mean change from baseline in BCVA(baseline to 9-month)
- Mean change from baseline in central retinal thickness(baseline to 9-month)
- Mean injection times(baseline to 9-month)
- Mean change from baseline in Macular edema volume and other anatomical character in the study eye(baseline to 9-month)
- Rate of adverse event(3-month and 9-month)
研究者
研究点 (2)
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