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

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ClinicalTrials.gov Identifier: NCT00312325

Recruitment Status : Completed

First Posted : April 10, 2006

Last Update Posted : April 10, 2006

Sponsor:

Information provided by:

Medical University of Vienna

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

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Study Type :	Interventional (Clinical Trial)
Enrollment :	24 participants
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 :	July 2005
Study Completion Date :	August 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Steroids

Drug Information available for: Prednisolone Prednisolone acetate Methylprednisolone acetate Methylprednisolone Prednisolone sodium phosphate Prednisolone phosphate Prednisolone sodium succinate Methylprednisolone sodium succinate

Genetic and Rare Diseases Information Center resources: Optic Neuritis

U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :

Non invasive measurement of optic nerve and choroidal blood flow

Eligibility Criteria

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Ages Eligible for Study:	19 Years to 65 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00312325

Locations

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Austria
Department of Clinical Pharmacology
Vienna, Austria, 1090

Sponsors and Collaborators

Medical University of Vienna

Investigators

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Principal Investigator:	Gabriele Fuchsjaeger-Mayrl, M.D.	Medical University of Vienna

More Information

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ClinicalTrials.gov Identifier:	NCT00312325 History of Changes
Other Study ID Numbers:	OPHT-030602
First Posted:	April 10, 2006 Key Record Dates
Last Update Posted:	April 10, 2006
Last Verified:	March 2006

Keywords provided by Medical University of Vienna:


Optic nerve head blood flow Choroidal blood flow Prednisolone Graves´ Ophthalmopathy optic neuritis

Additional relevant MeSH terms:

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Prednisolone Methylprednisolone Acetate Methylprednisolone Methylprednisolone Hemisuccinate Prednisolone acetate Prednisolone hemisuccinate Prednisolone phosphate Anti-Inflammatory Agents Glucocorticoids Hormones	Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Antineoplastic Agents, Hormonal Antineoplastic Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Gastrointestinal Agents Neuroprotective Agents Protective Agents

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