A Randomized, Placebo-controlled Study Investigating the Effects of Moxaverine on Ocular Blood Flow After Oral Administration in Healthy Subjects

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized, Placebo-controlled Study Investigating the Effects of Moxaverine on Ocular Blood Flow After Oral Administration in Healthy Subjects

Conditions
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Effect of Orally Administrated Moxaverine on Ocular Blood Flow

Intervention / Treatment
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* Drug: Moxaverine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Healthy subjects I<br> | Drug: Moxaverine<br>* Moxaverine-hydrochloride, coated tablets containing 150 mg moxaverine (Kollateral forte, Ursapharm. Saarbrücken, Germany), dosage: 900 mg, administrated per os in three equal doses of 300 mg at two hour intervals<br>|
| Placebo Comparator: Healthy subjects II<br> | Drug: Placebo<br>* coated tablets identical in number and appearance as the study drug<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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moxaverine, ocular blood flow