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

Regional Blood Flow Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00312325
• Other study ID #: OPHT-030602
• Status: Completed
• Phase: Phase 4
• First received: April 6, 2006
• Last updated: April 7, 2006
• Start date: July 2005
• Est. completion date: August 2005

Study information

• Verified date: March 2006
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Federal Ministry for Health and Women
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: August 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 65 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Optic Disk
• Regional Blood Flow

Intervention

Drug:
• Prednisolone

Locations

Country	Name	City	State
Austria	Department of Clinical Pharmacology	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Non invasive measurement of optic nerve and choroidal blood flow