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

Purpose

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	Intervention	Phase
Effect of Orally Administrated Moxaverine on Ocular Blood Flow	Drug: Moxaverine Drug: Placebo	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, 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

Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:

Choroidal and optic nerve head blood flow [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
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 [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
Change in retrobulbar flow velocities after administration of moxaverine compared to placebo (measured before administration and 6 hours after administration)

Enrollment:	16
Study Start Date:	October 2010
Study Completion Date:	June 2011
Primary Completion Date:	March 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility

Ages Eligible for Study:	18 Years to 35 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01629680

Locations

Austria
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

More Information

No publications provided

Responsible Party:	Gerhard Garhofer, Associate Prof. PD Dr, Medical University of Vienna
ClinicalTrials.gov Identifier:	NCT01629680 History of Changes
Other Study ID Numbers:	OPHT-080210
Study First Received:	June 11, 2012
Last Updated:	June 26, 2012
Health Authority:	Austria: Agency for Health and Food Safety

Keywords provided by Medical University of Vienna:

moxaverine
ocular blood flow

Additional relevant MeSH terms:

Moxaverine
Papaverine
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions

Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 21, 2013