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

November 30, 2009 updated by: Medical University of Vienna

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, 1090
        • Department of Clinical Pharmacology, Medical University of Vienna

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Choroidal and optic nerve head blood flow
Time Frame: 2 hours
2 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Retrobulbar flow velocities
Time Frame: 2 hours
2 hours
Retinal blood flow velocity
Time Frame: 2 hours
2 hours
Retinal venous and arterial diameters
Time Frame: 2 hours
2 hours
Intraocular pressure
Time Frame: 2 hours
2 hours
Systolic and diastolic blood pressure
Time Frame: 2 hours
2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Vienna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2008

Primary Completion (Actual)

March 1, 2009

Study Completion (Actual)

March 1, 2009

Study Registration Dates

First Submitted

June 27, 2008

First Submitted That Met QC Criteria

July 2, 2008

First Posted (Estimate)

July 3, 2008

Study Record Updates

Last Update Posted (Estimate)

December 1, 2009

Last Update Submitted That Met QC Criteria

November 30, 2009

Last Verified

November 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OPHT-011007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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