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

NCT ID: NCT01629680

Last Updated: 2012-06-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-31
• Study Completion Date: 2011-06-30

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.

Conditions

Effect of Orally Administrated Moxaverine on Ocular Blood Flow

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: TRIPLE

Study Groups

Healthy subjects I

Group Type: EXPERIMENTAL

Moxaverine

Intervention Type: DRUG

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

Healthy subjects II

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

coated tablets identical in number and appearance as the study drug

Interventions

Moxaverine

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

Intervention Type: DRUG

Placebo

coated tablets identical in number and appearance as the study drug

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Medical University of Vienna

OTHER

Sponsor Role: lead

Responsible Party

Gerhard Garhofer

Associate Prof. PD Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gerhard Garhoefer, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Clinical Pharmacology, Medical University of Vienna

Locations

Department of Clinical Pharmacology, Medical University of Vienna

Vienna, , Austria

Countries

Austria

Other Identifiers

OPHT-080210

Identifier Type: -

Identifier Source: org_study_id