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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

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ClinicalTrials.gov Identifier: NCT00709449
Recruitment Status : Completed
First Posted : July 3, 2008
Last Update Posted : December 1, 2009
Sponsor:
Information provided by:
Medical University of Vienna

Study Description
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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.


Condition or disease Intervention/treatment Phase
Macular Degeneration Glaucoma Regional Blood Flow Drug: moxaverine Phase 2 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : May 2008
Actual Primary Completion Date : March 2009
Actual Study Completion Date : March 2009

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: 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 Name: 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 Name: Collateral i


Outcome Measures
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Primary Outcome Measures :
  1. Choroidal and optic nerve head blood flow [ Time Frame: 2 hours ]

Secondary Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00709449


Locations
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Austria
Department of Clinical Pharmacology, Medical University of Vienna
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
More Information
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Responsible Party: Gerhard Garhöfer, MD, Department of Clinical Pharmacology, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT00709449    
Other Study ID Numbers: OPHT-011007
First Posted: July 3, 2008    Key Record Dates
Last Update Posted: December 1, 2009
Last Verified: November 2009
Keywords provided by Medical University of Vienna:
Age-related macular degeneration
Glaucoma
Additional relevant MeSH terms:
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Glaucoma
Macular Degeneration
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases
Retinal Degeneration
Retinal Diseases
Papaverine
Moxaverine
 Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Urological Agents