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

Sponsor

Medical University of Vienna (Other)

Overall Status

Completed

CT.gov ID

NCT00709449

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 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.

Condition or Disease	Intervention/Treatment	Phase
Macular Degeneration Glaucoma Regional Blood Flow	Drug: moxaverine Drug: moxaverine Drug: moxaverine	Phase 2/Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

May 1, 2008

Actual Primary Completion Date :

Mar 1, 2009

Actual Study Completion Date :

Mar 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 20 patients with age related macular degeneration	Drug: moxaverine intravenous infusion of 150 mg in 250 ml NaCl, applied over 30 minutes. Other Names: Collateral i
Experimental: 2 20 patients with primary open angle glaucoma	Drug: moxaverine intravenous infusion of 150 mg in 250 ml NaCl, applied over 30 minutes. Other Names: Collateral i
Experimental: 3 20 age and sex matched control subjects	Drug: moxaverine intravenous infusion of 150 mg in 250 ml NaCl, applied over 30 minutes. Other Names: Collateral i

Arm

Intervention/Treatment

Experimental: 1

20 patients with age related macular degeneration

Drug: moxaverine

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

Other Names:

Collateral i

Experimental: 2

20 patients with primary open angle glaucoma

Drug: moxaverine

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

Other Names:

Collateral i

Experimental: 3

20 age and sex matched control subjects

Drug: moxaverine

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

Other Names:

Collateral i

Outcome Measures

Primary Outcome Measures

Choroidal and optic nerve head blood flow [2 hours]

Secondary Outcome Measures

Retrobulbar flow velocities [2 hours]
Retinal blood flow velocity [2 hours]
Retinal venous and arterial diameters [2 hours]
Intraocular pressure [2 hours]
Systolic and diastolic blood pressure [2 hours]

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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