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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

Primary Purpose

Macular Degeneration, Glaucoma, Regional Blood Flow

Status

Completed

Phase

Phase 2

Locations

Austria

Study Type

Interventional

Intervention

moxaverine

About this trial

This is an interventional treatment trial for Macular Degeneration focused on measuring Age-related macular degeneration, Glaucoma

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Department of Clinical Pharmacology, Medical University of Vienna

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Arm Description

20 patients with age related macular degeneration

20 patients with primary open angle glaucoma

20 age and sex matched control subjects

Outcomes

Primary Outcome Measures

Choroidal and optic nerve head blood flow

Secondary Outcome Measures

Retrobulbar flow velocities

Retinal blood flow velocity

Retinal venous and arterial diameters

Intraocular pressure

Systolic and diastolic blood pressure

Full Information

NCT ID

NCT00709449

First Posted

June 27, 2008

Last Updated

November 30, 2009

Sponsor

Medical University of Vienna

1. Study Identification

Unique Protocol Identification Number

NCT00709449

Brief 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

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 Type

Interventional

2. Study Status

Record Verification Date

November 2009

Overall Recruitment Status

Completed

Study Start Date

May 2008 (undefined)

Primary Completion Date

March 2009 (Actual)

Study Completion Date

March 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Medical University of Vienna

4. Oversight

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Macular Degeneration, Glaucoma, Regional Blood Flow

Keywords

Age-related macular degeneration, Glaucoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

20 patients with age related macular degeneration

Arm Title

Arm Type

Experimental

Arm Description

20 patients with primary open angle glaucoma

Arm Title

Arm Type

Experimental

Arm Description

20 age and sex matched control subjects

Intervention Type

Drug

Intervention Name(s)

moxaverine

Other Intervention Name(s)

Collateral i

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

moxaverine

Other Intervention Name(s)

Collateral i

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

moxaverine

Other Intervention Name(s)

Collateral i

Intervention Description

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

Primary Outcome Measure Information:

Title

Choroidal and optic nerve head blood flow

Time Frame

2 hours

Secondary Outcome Measure Information:

Title

Retrobulbar flow velocities

Time Frame

2 hours

Title

Retinal blood flow velocity

Time Frame

2 hours

Title

Retinal venous and arterial diameters

Time Frame

2 hours

Title

Intraocular pressure

Time Frame

2 hours

Title

Systolic and diastolic blood pressure

Time Frame

2 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Department of Clinical Pharmacology, Medical University of Vienna

City

Vienna

ZIP/Postal Code

1090

Country

Austria

12. IPD Sharing Statement

Learn more about this trial

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

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