An Open Study Comparing the Effects of Moxaverine on Ocular Blood Flow in Patients With Age- Related Macular Degeneration, Primary Open Angle Glaucoma and Healthy Control Subjects
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Choroidal and optic nerve head blood flow
研究概览
简要总结
A number of common eye diseases such as age-related macular degeneration and glaucoma 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.
For many years, moxaverine has been used in the therapy of perfusion abnormalities in the brain, the heart and the extremities. This is based on a direct vasodilatatory effect of the drug, but also on the rheological properties of red blood cells. In a recent study the investigators have shown that intravenous moxaverine increases choroidal blood flow in healthy young subjects. The present study aims to investigate, whether moxaverine also improves blood flow in the diseased eye after systemic administration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- 是
入选标准
- •Men and women aged over 50 years
- •Ametropia of less than 6 diopters and anisometropia of less than 2 diopters
- •Clear non-lenticular ocular media
- •AMD patients:
- •Patients with nonexudative AMD
- •Visual acuity in the study eye > 20/60
- •Glaucoma patients:
- •Unilateral or bilateral primary open angle glaucoma
- •At least 3 reliable visual field testings
- •Treated intraocular pressure < 21 mmHg,
- •Visual field mean deviation MD <10 (Humphrey 30-2)
- •Healthy control subjects:
- •Age- , gender- and sex- matched to the two patient groups,
- •Matched with regard to smoking habits of the two patient group
- •No observable eye diseases
排除标准
- •History or presence of gastrointestinal, liver or kidney disease, or other conditions known to interfere with distribution, metabolism or excretion of the study drug
- •Blood donation during the previous 3 weeks
- •Abuse of alcoholic beverages or drugs, participation in a clinical trial in the 3 weeks preceding the study
- •Known diabetes mellitus
- •Presence of any ocular pathology that interferes with the aims of the present study
- •Intraocular surgery within the last 3 weeks
- •Hypersensitivity to moxaverine
- •Acute gastric bleeding, massive cerebral hemorrhage related to stroke
研究组 & 干预措施
3
20 age and sex matched control subjects
干预措施: moxaverine (Drug)
1
20 patients with age related macular degeneration
干预措施: moxaverine (Drug)
2
20 patients with primary open angle glaucoma
干预措施: moxaverine (Drug)
结局指标
主要结局
Choroidal and optic nerve head blood flow
时间窗: 2 hours
次要结局
- Retrobulbar flow velocities(2 hours)
- Retinal blood flow velocity(2 hours)
- Retinal venous and arterial diameters(2 hours)
- Intraocular pressure(2 hours)
- Systolic and diastolic blood pressure(2 hours)