Clinical trial NCT01629680: A Randomized, Placebo-controlled Study Investigating the Effects of Moxaverine on Ocular Blood Flow After Oral Administration in Healthy Subjects
Official title: A Randomized, Placebo-controlled Study Investigating the Effects of Moxaverine on Ocular Blood Flow After Oral Administration in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Effect of Orally Administrated Moxaverine on Ocular Blood Flow
Keywords: moxaverine
ocular blood flow
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2012-06-27
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Choroidal and optic nerve head blood flow
timeFrame: 2 weeks
Secondary outcomes:
measure: Retrobulbar flow velocities
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Department of Clinical Pharmacology, Medical University of Vienna
Study officials:
affiliation: Department of Clinical Pharmacology, Medical University of Vienna
name: Gerhard Garhoefer, MD
role: PRINCIPAL_INVESTIGATOR
References: