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CompletedNCT00312325Updated Apr 10, 2006

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

A Phase 4 interventional study of Prednisolone in Regional Blood Flow and Optic Disk, sponsored by Medical University of Vienna. Completed at 1 site in Austria. Open to participants aged 19 Years to 65 Years. Per ClinicalTrials.gov, last updated 2006-04-10.

Sponsored by Medical University of Vienna · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
24
Allocation
Non-randomized
Ages
19 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Regional Blood Flow
  • Optic Disk

Keywords

  • Optic nerve head blood flow
  • Choroidal blood flow
  • Prednisolone
  • Graves´ Ophthalmopathy
  • optic neuritis
03

In context

Lead sponsor

Medical University of Vienna is the lead sponsor of 1,076 studies on the registry; 177 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
24 participants

Interventions

  • DrugPrednisolone
06

What researchers measure

Primary outcomes

  1. Non invasive measurement of optic nerve and choroidal blood flow

07

Study locations

1 site
  • Department of Clinical Pharmacology
    Vienna, 1090, Austria
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 10, 2006, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00312325
Lead sponsor
Medical University of Vienna
First posted
Apr 10, 2006
Start date
Jul 2005
Completion
Aug 2005
Last update
Apr 10, 2006

Study contacts

Gabriele Fuchsjaeger-Mayrl, M.D.
principal investigator · Medical University of Vienna
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2006. You cannot join it, but the record below documents what was studied.

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