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

This study has been completed.

First Received: April 6, 2006 Last Updated: April 7, 2006 History of Changes

Sponsor:	Medical University of Vienna
Information provided by:	Medical University of Vienna
ClinicalTrials.gov Identifier:	NCT00312325

Purpose

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	Intervention	Phase
Regional Blood Flow Optic Disk	Drug: Prednisolone	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Official Title:	Effect of High-Dose Prednisolone (Solu Dacortin®) Treatment on Choroidal and Optic Nerve Head Blood Flow in Humans

Resource links provided by NLM:

Drug Information available for: Prednisolone Prednisolone acetate Depo-medrol Medrol veriderm Methylprednisolone Prednisolone sodium phosphate Prednisolone Sodium Succinate Methylprednisolone Sodium Succinate Methylprednisolone hemisuccinate 6-Methylprednisolone

U.S. FDA Resources

Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:

Non invasive measurement of optic nerve and choroidal blood flow

Estimated Enrollment:	24
Study Start Date:	July 2005
Estimated Study Completion Date:	August 2005

Eligibility

Ages Eligible for Study:	19 Years to 65 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00312325

Locations

Austria
Department of Clinical Pharmacology
Vienna, Austria, 1090

Sponsors and Collaborators

Medical University of Vienna

Investigators

Principal Investigator:

Gabriele Fuchsjaeger-Mayrl, M.D.

Medical University of Vienna

More Information

No publications provided

Study ID Numbers:	OPHT-030602
Study First Received:	April 6, 2006
Last Updated:	April 7, 2006
ClinicalTrials.gov Identifier:	NCT00312325 History of Changes
Health Authority:	Austria: Federal Ministry for Health and Women

Keywords provided by Medical University of Vienna:

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

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Methylprednisolone
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Methylprednisolone acetate
Prednisolone acetate
Protective Agents

Neuroprotective Agents
Glucocorticoids
Hormones
Pharmacologic Actions
Autonomic Agents
Therapeutic Uses
Prednisolone
Peripheral Nervous System Agents
Central Nervous System Agents
Methylprednisolone Hemisuccinate

ClinicalTrials.gov processed this record on February 08, 2010