NCT00312325已完成4 期
Effect of High-Dose Prednisolone (Solu Dacortin®) Treatment on Choroidal and Optic Nerve Head Blood Flow in Humans
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Non invasive measurement of optic nerve and choroidal blood flow
研究概览
简要总结
Because of their antiinflamatory effects, glucocorticoids are often used to reduce edema in neurologic tissue and to otherwise mitigate the consequences of neural inflammation. For example, high dose prednisolone treatment has been shown to be an effective therapy for different eye diseases including severe Graves´ Ophthalmopathy and acute optic neuritis. However, contradictory results exists for the influence of high dose prednisolone therapy per se on tissue blood flow. Thus, in the current study, we plan to investigate the effect of high dose, short time therapy with intravenous prednisolone in patients with optic neuritis and severe Graves´ Ophthalmopathy.
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
- 19 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women aged between 19 and 65 years, nonsmokers
- •Group A: Patients with Graves´ Ophthalmopathy (moderate to severe and active ophthalmopathy; i.e. clinical activity score >3 or =3) suitable for high-dose treatment with prednisolone as assessed by an independent ophthalmologist
- •Group B: Patients with acute onset of optic neuritis suitable for high-dose treatment with prednisolone suitable for high-dose treatment with prednisolone as assessed by the ophthalmologist
- •Normal laboratory values unless the investigator considers an abnormality to be clinically irrelevant and not to interfere with prednisolone treatment (normal liver blood parameter and hepatitis serology).
- •Ametropy of less than 3 dpt.
排除标准
- •Regular use of medication which could interfere with the study objectives, especially treatment with vasoactive drugs
- •Active peptic ulcer or insulin dependent diabetes mellitus
- •Hepatitis or elevated hepatic blood parameters
- •Abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study
- •Symptoms of a clinically relevant illness in the 3 weeks before the first study day
- •Blood donation during the previous 3 weeks
- •Pregnancy
结局指标
主要结局
Non invasive measurement of optic nerve and choroidal blood flow
次要结局
未报告次要终点
研究者
研究点 (2)
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