A Randomized, Double-Masked, Placebo-Controlled Two Cross Over Study Comparing the Effects of Moxaverine and Placebo on Ocular Blood Flow
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Retinal blood flow (Laser Doppler Velocimetry, Retinal Vessel Analyzer)
研究概览
简要总结
A number of common eye diseases such as retinal artery and vein occlusion, diabetic retinopathy, age-related macular degeneration, glaucoma and anterior ischemic optic neuropathy are associated with ocular perfusion abnormalities. Although this is well recognized there is not much possibility to improve blood flow to the posterior pole of the eye in these diseases.
Since many years, moxaverine is used in the therapy of perfusion abnormalities in the brain, the heart and the extremities. This is based on a direct vasodilator effect of the drug, but also on the rheological properties of red blood cells. Whether moxaverine affects blood flow in the eye is unknown. The present study aims to investigate whether moxaverine may improves blood flow in the eye after systemic administration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women aged between 18 and 35 years, nonsmokers
- •Body mass index between 15th and 85th percentile
- •Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
- •Normal laboratory values unless the investigator considers an abnormality to be clinically irrelevant
- •Normal ophthalmic findings, ametropy < 3 dpt.
排除标准
- •Regular use of medication, abuse of alcoholic beverages or drugs, participation in a clinical trial in the 3 weeks preceding the study
- •Treatment in the previous 3 weeks with any drug
- •Symptoms of a clinically relevant illness in the 3 weeks before the first study day
- •History or presence of gastrointestinal, liver or kidney disease, or other conditions known to interfere with distribution, metabolism or excretion of study drugs
- •Blood donation during the previous 3 weeks
- •Ametropy >= 3 dpt
- •Acute gastric bleeding, massive cerebral hemorrhage related to stroke
- •Women: pregnancy or lactation
研究组 & 干预措施
2
干预措施: NaCl (Drug)
1
干预措施: Moxaverine (Drug)
1
干预措施: Moxaverin 150mg (Drug)
结局指标
主要结局
Retinal blood flow (Laser Doppler Velocimetry, Retinal Vessel Analyzer)
时间窗: 2 hours
Choroidal and optic nerve head blood flow (Laser Doppler Flowmetry)
时间窗: 2 hours
次要结局
未报告次要终点