Effect of High-Dose Prednisolone (Solu Dacortin®) Treatment on Choroidal and Optic Nerve Head Blood Flow in Humans
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00312325 |
Recruitment Status :
Completed
First Posted : April 10, 2006
Last Update Posted : April 10, 2006
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Regional Blood Flow Optic Disk | Drug: Prednisolone | Phase 4 |
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 |

- Non invasive measurement of optic nerve and choroidal blood flow

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 19 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | 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:
- 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

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
Austria | |
Department of Clinical Pharmacology | |
Vienna, Austria, 1090 |
Principal Investigator: | Gabriele Fuchsjaeger-Mayrl, M.D. | Medical University of Vienna |
ClinicalTrials.gov Identifier: | NCT00312325 |
Other Study ID Numbers: |
OPHT-030602 |
First Posted: | April 10, 2006 Key Record Dates |
Last Update Posted: | April 10, 2006 |
Last Verified: | March 2006 |
Optic nerve head blood flow Choroidal blood flow Prednisolone Graves´ Ophthalmopathy optic neuritis |
Prednisolone Anti-Inflammatory Agents Glucocorticoids Hormones |
Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Antineoplastic Agents, Hormonal Antineoplastic Agents |