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OpenTrials
Completed

NCT Number: NCT00709449

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

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.

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Key information

Conditions

Macular Degeneration Eye Diseases Glaucoma Ocular Hypertension Regional Blood Flow Retinal Degeneration Retinal Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Department of Clinical Pharmacology, Medical University of Vienna

Vienna, 1090, Austria

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Moxaverine

Drug

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

Other names: Collateral i

Primary outcomes

  1. Choroidal and optic nerve head blood flow

    Time frame: 2 hours

Secondary outcomes

  1. Retrobulbar flow velocities

    Time frame: 2 hours

  2. Retinal blood flow velocity

    Time frame: 2 hours

  3. Retinal venous and arterial diameters

    Time frame: 2 hours

  4. Intraocular pressure

    Time frame: 2 hours

  5. Systolic and diastolic blood pressure

    Time frame: 2 hours

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jul 3, 2008
Registry last updated
Dec 1, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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