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An Open Study Comparing the Effects of Moxaverine on Ocular Blood Flow in Patients With Age- Related Macular Degeneration, Primary Open Angle Glaucoma and Healthy Control Subjects

NCT ID: NCT00709449

Last Updated: 2009-12-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2009-03-31

Brief Summary

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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 a recent study the investigators have shown that intravenous moxaverine increases choroidal blood flow in healthy young subjects. The present study aims to investigate, whether moxaverine also improves blood flow in the diseased eye after systemic administration.

Detailed Description

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Conditions

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Macular Degeneration Glaucoma Regional Blood Flow

Keywords

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Age-related macular degeneration Glaucoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

20 patients with age related macular degeneration

Group Type EXPERIMENTAL

moxaverine

Intervention Type DRUG

intravenous infusion of 150 mg in 250 ml NaCl, applied over 30 minutes.

2

20 patients with primary open angle glaucoma

Group Type EXPERIMENTAL

moxaverine

Intervention Type DRUG

intravenous infusion of 150 mg in 250 ml NaCl, applied over 30 minutes.

3

20 age and sex matched control subjects

Group Type EXPERIMENTAL

moxaverine

Intervention Type DRUG

intravenous infusion of 150 mg in 250 ml NaCl, applied over 30 minutes.

Interventions

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moxaverine

intravenous infusion of 150 mg in 250 ml NaCl, applied over 30 minutes.

Intervention Type DRUG

moxaverine

intravenous infusion of 150 mg in 250 ml NaCl, applied over 30 minutes.

Intervention Type DRUG

moxaverine

intravenous infusion of 150 mg in 250 ml NaCl, applied over 30 minutes.

Intervention Type DRUG

Other Intervention Names

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Collateral i Collateral i Collateral i

Eligibility Criteria

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Inclusion Criteria

* Men and women aged over 50 years
* Ametropia of less than 6 diopters and anisometropia of less than 2 diopters
* Clear non-lenticular ocular media

AMD patients:

* Patients with nonexudative AMD
* Visual acuity in the study eye \> 20/60

Glaucoma patients:

* Unilateral or bilateral primary open angle glaucoma
* At least 3 reliable visual field testings
* Treated intraocular pressure \< 21 mmHg,
* Visual field mean deviation MD \<10 (Humphrey 30-2)

Healthy control subjects:

* Age- , gender- and sex- matched to the two patient groups,
* Matched with regard to smoking habits of the two patient group
* No observable eye diseases

Exclusion Criteria

* 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
* Abuse of alcoholic beverages or drugs, participation in a clinical trial in the 3 weeks preceding the study
* Known diabetes mellitus
* Presence of any ocular pathology that interferes with the aims of the present study
* Intraocular surgery within the last 3 weeks
* Hypersensitivity to moxaverine
* Acute gastric bleeding, massive cerebral hemorrhage related to stroke
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Medical University of Vienna

OTHER

Sponsor Role lead

Responsible Party

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Department of Clinical Pharmacology, Medical University of Vienna

Locations

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Department of Clinical Pharmacology, Medical University of Vienna

Vienna, , Austria

Site Status

Countries

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Austria

Other Identifiers

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OPHT-011007

Identifier Type: -

Identifier Source: org_study_id