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

Sponsor

Medical University of Vienna (Other)

Overall Status

Completed

CT.gov ID

NCT01629680

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Effect of Orally Administrated Moxaverine on Ocular Blood Flow	Drug: Moxaverine Drug: Placebo	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

16 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Basic Science

Official Title:

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

Study Start Date :

Oct 1, 2010

Actual Primary Completion Date :

Mar 1, 2011

Actual Study Completion Date :

Jun 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Healthy subjects I	Drug: 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
Placebo Comparator: Healthy subjects II	Drug: Placebo coated tablets identical in number and appearance as the study drug

Arm

Intervention/Treatment

Experimental: Healthy subjects I

Drug: 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

Placebo Comparator: Healthy subjects II

Drug: Placebo

coated tablets identical in number and appearance as the study drug

Outcome Measures

Primary Outcome Measures

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

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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 35 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Clinical Pharmacology, Medical University of Vienna	Vienna		Austria	1090

Sponsors and Collaborators

Medical University of Vienna

Investigators

Principal Investigator: Gerhard Garhoefer, MD, Department of Clinical Pharmacology, Medical University of Vienna

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Gerhard Garhofer, Associate Prof. PD Dr, Medical University of Vienna

ClinicalTrials.gov Identifier:

NCT01629680

Other Study ID Numbers:

OPHT-080210

First Posted:

Jun 27, 2012

Last Update Posted:

Jun 27, 2012

Last Verified:

Jun 1, 2012

Keywords provided by Gerhard Garhofer, Associate Prof. PD Dr, Medical University of Vienna

moxaverine

ocular blood flow

Additional relevant MeSH terms:

Moxaverine

Study Results

No Results Posted as of Jun 27, 2012