NCT01638858已完成不适用
A Prospective, Non-randomized, Mono-center, Cohort Study of Evaluate the Effects of 0.5mg Intraocular Ranibizumab (Lucentis)Injections on Retinal Function in Patients With Diabetic Macular Edema (DME) During Twelve Months
University of Luebeck1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2011年10月最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Main outcome measures are the changes of retinal function of the macula monitored by multifocal-ERG as measured 12 months
研究概览
简要总结
In this prospective, open-label clinical study is to investigate the behavior of the retinal functions during development of diabetic macular disease (DME) under the influence of Lucentis. Measurements with the multifocal electroretinogram (ERG) and microperimetry is used here as an objective criteria to information about the retinal function obtain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •diabetic macular edema with center involvement in at least one eye
- •patients with a central retinal thickness
- •patients with a BCVA of 78-24 EDTRS letters
- •decrease in vision is due to DME and not due to other causes, in the opinion of the investigator
- •Type 1 or type 2 diabetes mellitus diagnosed 2 years prior to screening
排除标准
- •history or evidence of severe cardiac disease
- •clinical or medical history uncontrolled hypertension or diabetes
- •of unstable angina, acute coronary syndrome, myocardial infarction or revascularization with 6 months
- •ventricular tachyarrhythmias requiring ongoing treatment
- •history or evidence clinically significant peripheral vascular disease, such a intermittent claudication or prior amputation
- •clinically significant impaired renal or hepatic function
研究组 & 干预措施
Lucentis (Ranibizumab)
Experimental
干预措施: Lucentis (Ranibizumab) (Drug)
结局指标
主要结局
Main outcome measures are the changes of retinal function of the macula monitored by multifocal-ERG as measured 12 months
时间窗: 12 months
Main outcome measures are the changes of retinal function of the macula monitored by multifocal-ERG as measured 12 months
次要结局
- to document changes in best corrected visual acuity measured on 4 meters(12 months)
- to document changes in microperimetry(12 months)
- to document changes in optical coherence tomography (OCT)(12 months)
研究者
Dr. Matthias Lueke
Principal Investigator
University of Luebeck
研究点 (1)
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