Effect of High-Dose Prednisolone (Solu Dacortin®) Treatment on Choroidal and Optic Nerve Head Blood Flow in Humans
Information source: Medical University of Vienna
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Regional Blood Flow; Optic Disk
Intervention: Prednisolone (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Medical University of Vienna Official(s) and/or principal investigator(s):
Gabriele Fuchsjaeger-Mayrl, M.D., Principal Investigator, Affiliation: Medical University of Vienna
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 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.
Clinical Details
Official title: Effect of High-Dose Prednisolone (Solu Dacortin®) Treatment on Choroidal and Optic Nerve Head Blood Flow in Humans
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Non invasive measurement of optic nerve and choroidal blood flow
Eligibility
Minimum age: 19 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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 Criteria:
- 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
Locations and Contacts
Department of Clinical Pharmacology, Vienna 1090, Austria
Additional Information
Starting date: July 2005
Ending date: August 2005
Last updated: April 7, 2006
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