Effect of Orally Administrated Moxaverine on Ocular Blood Flow Clinical Trial
Official title:
A Randomized, Placebo-controlled Study Investigating the Effects of Moxaverine on Ocular Blood Flow After Oral Administration in Healthy Subjects
| Verified date | June 2012 |
| Source | Medical University of Vienna |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Austria: Agency for Health and Food Safety |
| Study type | Interventional |
A number of common eye diseases such as age-related macular degeneration and glaucoma are
associated with ocular perfusion abnormalities. Although this is well recognized there is
not much possibility to improve blood flow to the posterior pole of the eye in these
diseases.
For many years, moxaverine has been used in the therapy of perfusion abnormalities in the
brain, the heart and the extremities. This is based on a direct vasodilatatory effect of the
drug, but also on the rheological properties of red blood cells. In two recent studies the
investigators have shown that intravenous moxaverine increases choroidal and retrobulbar
blood flow in healthy young subjects, in elderly people with healthy eyes and in patients
with eye diseases associated with hypoperfusion. The present study aims to investigate,
whether ocular blood flow is also improved after oral administration of moxaverine.
| Status | Completed |
| Enrollment | 16 |
| Est. completion date | June 2011 |
| Est. primary completion date | March 2011 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 18 Years to 35 Years |
| Eligibility |
Inclusion Criteria: - Men and women aged between 18 and 35 years, nonsmoker - Body mass index between 16 and 30 kg/m² - Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant - Normal laboratory values unless the investigator considers an abnormality to be clinically irrelevant - Normal ophthalmic findings, ametropia < 6 dpt, anisometropia < 2 dpt Exclusion Criteria: - Regular use of medication, abuse of alcoholic beverages or drugs - Participation in a clinical trial in the 3 weeks preceding the study - Treatment in the previous 3 weeks with any drug - Symptoms of a clinically relevant illness in the 3 weeks before the first study day - History or presence of gastrointestinal, liver or kidney disease, or other conditions known to interfere with distribution, metabolism or excretion of the study drug - Blood donation during the previous 3 weeks - Presence of any ocular pathology that interferes with the aims of the present study - Hypersensitivity to moxaverine - Acute gastric bleeding, massive cerebral hemorrhage related to stroke - Women: pregnancy or lactation |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Basic Science
| Country | Name | City | State |
|---|---|---|---|
| Austria | Department of Clinical Pharmacology, Medical University of Vienna | Vienna |
| Lead Sponsor | Collaborator |
|---|---|
| Medical University of Vienna |
Austria,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Choroidal and optic nerve head blood flow | Change in choroidal and optic nerve head blood flow after administration of moxaverine compared to placebo (measured before administration and 6 hours after administration) | 2 weeks | No |
| Secondary | Retrobulbar flow velocities | Change in retrobulbar flow velocities after administration of moxaverine compared to placebo (measured before administration and 6 hours after administration) | 2 weeks | No |