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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

This study has been completed.
Sponsor:
Information provided by:
Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT00709449
First received: June 27, 2008
Last updated: November 30, 2009
Last verified: November 2009
History of Changes
  Purpose

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 Intervention Phase
Macular Degeneration
Glaucoma
Regional Blood Flow
 Drug: moxaverine
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • Choroidal and optic nerve head blood flow [ Time Frame: 2 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Retrobulbar flow velocities [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
  • Retinal blood flow velocity [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
  • Retinal venous and arterial diameters [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
  • Intraocular pressure [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
  • Systolic and diastolic blood pressure [ Time Frame: 2 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: May 2008
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00709449

Locations
Austria
Department of Clinical Pharmacology, Medical University of Vienna
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
  More Information

No publications provided

Responsible Party: Gerhard Garhöfer, MD, Department of Clinical Pharmacology, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT00709449     History of Changes
Other Study ID Numbers: OPHT-011007
Study First Received: June 27, 2008
Last Updated: November 30, 2009
Health Authority: Austria: Agency for Health and Food Safety

Keywords provided by Medical University of Vienna:
Age-related macular degeneration
Glaucoma

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Macular Degeneration
Ocular Hypertension
Eye Diseases
Retinal Degeneration
Retinal Diseases
Moxaverine
Papaverine
Parasympatholytics
 Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013