Effect of High-Dose Prednisolone (Solu Dacortin®) Treatment on Choroidal and Optic Nerve Head Blood Flow in Humans

Sponsor

Medical University of Vienna (Other)

Overall Status

Completed

CT.gov ID

NCT00312325

Collaborator

(none)

Enrollment

Location

Duration (Months)

23.6

Patients Per Site Per Month

Study Details

Study Description

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 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.

Condition or Disease	Intervention/Treatment	Phase
Regional Blood Flow Optic Disk	Drug: Prednisolone	Phase 4

Study Design

Study Type:

Interventional

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Effect of High-Dose Prednisolone (Solu Dacortin®) Treatment on Choroidal and Optic Nerve Head Blood Flow in Humans

Study Start Date :

Jul 1, 2005

Study Completion Date :

Aug 1, 2005

Outcome Measures

Primary Outcome Measures

Non invasive measurement of optic nerve and choroidal blood flow []

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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