Effects of Moxaverine and Placebo on Ocular Blood Flow

Study Overview
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Brief Summary
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A number of common eye diseases such as retinal artery and vein occlusion, diabetic retinopathy, age-related macular degeneration, glaucoma and anterior ischemic optic neuropathy 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. Since many years, moxaverine is used in the therapy of perfusion abnormalities in the brain, the heart and the extremities. This is based on a direct vasodilator effect of the drug, but also on the rheological properties of red blood cells. Whether moxaverine affects blood flow in the eye is unknown. The present study aims to investigate whether moxaverine may improves blood flow in the eye after systemic administration.

Official Title
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A Randomized, Double-Masked, Placebo-Controlled Two Cross Over Study Comparing the Effects of Moxaverine and Placebo on Ocular Blood Flow

Conditions
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Regional Blood Flow, Ocular Physiology, Retina

Intervention / Treatment
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* Drug: Moxaverine
* Drug: Moxaverin 150mg
* Drug: NaCl


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women aged between 18 and 35 years, nonsmokers Body mass index between 15th and 85th percentile 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, ametropy < 3 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 study drugs Blood donation during the previous 3 weeks Ametropy >= 3 dpt 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: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br> | Drug: Moxaverine<br> <br> Drug: Moxaverin 150mg<br>* intravenous administration<br>* Other names: Collateral i;|
| Placebo Comparator: 2<br> | Drug: NaCl<br>* intravenous administration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retinal blood flow (Laser Doppler Velocimetry, Retinal Vessel Analyzer) |  | 2 hours | 
| Choroidal and optic nerve head blood flow (Laser Doppler Flowmetry) |  | 2 hours |