DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

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

Information source: Medical University of Vienna
ClinicalTrials.gov processed this data on August 23, 2015
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


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: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Non invasive measurement of optic nerve and choroidal blood flow


Minimum age: 19 Years. Maximum age: 65 Years. Gender(s): Both.


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
Last updated: April 7, 2006

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017