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

Glaucoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00709449
• Other study ID #: OPHT-011007
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: June 27, 2008
• Last updated: November 30, 2009
• Start date: May 2008
• Est. completion date: March 2009

Study information

• Verified date: November 2009
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Agency for Health and Food Safety
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Macular Degeneration
• Regional Blood Flow

Intervention

Drug:
• moxaverine
intravenous infusion of 150 mg in 250 ml NaCl, applied over 30 minutes.
• moxaverine
intravenous infusion of 150 mg in 250 ml NaCl, applied over 30 minutes.
• moxaverine
intravenous infusion of 150 mg in 250 ml NaCl, applied over 30 minutes.

Locations

Country	Name	City	State
Austria	Department of Clinical Pharmacology, Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Choroidal and optic nerve head blood flow		2 hours	No
Secondary	Retrobulbar flow velocities		2 hours	No
Secondary	Retinal blood flow velocity		2 hours	No
Secondary	Retinal venous and arterial diameters		2 hours	No
Secondary	Intraocular pressure		2 hours	No
Secondary	Systolic and diastolic blood pressure		2 hours	No