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

Phase 2

Completed

• Conditions: Effect of Orally Administrated Moxaverine on Ocular Blood Flow
• Interventions: Drug: Moxaverine; Drug: Placebo

• Registration Number: NCT01629680
• Lead Sponsor: Medical University of Vienna

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10
• Primary Completion: 2011-03
• Study Completion: 2011-06
• Status Verified: 2012-06
• Study First Submitted: 2012-06-11
• Study First Submitted QC: 2012-06-26
• Last Update Submitted: 2012-06-26
• Study First Posted: 2012-06-27
• Last Update Posted: 2012-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Healthy subjects I	Moxaverine	-
Healthy subjects II	Placebo	-

Primary Outcome Measures

Name	Time	Method
Choroidal and optic nerve head blood flow	2 weeks	Change in choroidal and optic nerve head blood flow after administration of moxaverine compared to placebo (measured before administration and 6 hours after administration)

Secondary Outcome Measures

Name	Time	Method
Retrobulbar flow velocities	2 weeks	Change in retrobulbar flow velocities after administration of moxaverine compared to placebo (measured before administration and 6 hours after administration)

Trial Locations

Locations (1)

Department of Clinical Pharmacology, Medical University of Vienna; 🇦🇹 Vienna, Austria