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

Phase 2

Completed

• Conditions: Macular Degeneration; Glaucoma; Regional Blood Flow
• Interventions: Drug: moxaverine

• Registration Number: NCT00709449
• Lead Sponsor: Medical University of Vienna

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-05
• Study First Submitted: 2008-06-27
• Study First Submitted QC: 2008-07-02
• Study First Posted: 2008-07-03
• Primary Completion: 2009-03
• Study Completion: 2009-03
• Status Verified: 2009-11
• Last Update Submitted: 2009-11-30
• Last Update Posted: 2009-12-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	moxaverine	20 patients with age related macular degeneration
2	moxaverine	20 patients with primary open angle glaucoma
3	moxaverine	20 age and sex matched control subjects

Primary Outcome Measures

Name	Time	Method
Choroidal and optic nerve head blood flow	2 hours

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Department of Clinical Pharmacology, Medical University of Vienna; 🇦🇹 Vienna, Austria