Status:
COMPLETED
Effect of High-Dose Prednisolone (Solu Dacortin®) Treatment on Choroidal and Optic Nerve Head Blood Flow in Humans
Lead Sponsor:
Medical University of Vienna
Conditions:
Regional Blood Flow
Optic Disk
Eligibility:
All Genders
19-65 years
Phase:
PHASE4
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
End Date :
August 1 2005
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00312325
Start Date
July 1 2005
End Date
August 1 2005
Last Update
April 10 2006
Active Locations (1)
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1
Department of Clinical Pharmacology
Vienna, Austria, 1090