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Effects of Moxaverine and Placebo on Ocular Blood Flow

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00709423
Recruitment Status : Completed
First Posted : July 3, 2008
Last Update Posted : July 3, 2008
Sponsor:
Information provided by:
Medical University of Vienna

Study Description
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Brief Summary:

A number of common eye diseases such as retinal artery and vein occlusion, diabetic retinopathy, age-related macular degeneration, glaucoma and anterior ischemic optic neuropathy 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.

Since many years, moxaverine is used in the therapy of perfusion abnormalities in the brain, the heart and the extremities. This is based on a direct vasodilator effect of the drug, but also on the rheological properties of red blood cells. Whether moxaverine affects blood flow in the eye is unknown. The present study aims to investigate whether moxaverine may improves blood flow in the eye after systemic administration.


Condition or disease Intervention/treatment Phase
Regional Blood Flow Ocular Physiology Retina Drug: Moxaverine Drug: Moxaverin 150mg Drug: NaCl Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Masked, Placebo-Controlled Two Cross Over Study Comparing the Effects of Moxaverine and Placebo on Ocular Blood Flow
Study Start Date : March 2007
Actual Primary Completion Date : May 2007
Actual Study Completion Date : May 2007

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 1 Drug: Moxaverine
Drug: Moxaverin 150mg
intravenous administration
Other Name: Collateral i
Placebo Comparator: 2 Drug: NaCl
intravenous administration


Outcome Measures
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Primary Outcome Measures :
  1. Retinal blood flow (Laser Doppler Velocimetry, Retinal Vessel Analyzer) [ Time Frame: 2 hours ]
  2. Choroidal and optic nerve head blood flow (Laser Doppler Flowmetry) [ Time Frame: 2 hours ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Men and women aged between 18 and 35 years, nonsmokers
  • Body mass index between 15th and 85th percentile
  • Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
  • Normal laboratory values unless the investigator considers an abnormality to be clinically irrelevant
  • Normal ophthalmic findings, ametropy < 3 dpt.

Exclusion Criteria:

  • Regular use of medication, abuse of alcoholic beverages or drugs, participation in a clinical trial in the 3 weeks preceding the study
  • Treatment in the previous 3 weeks with any drug
  • Symptoms of a clinically relevant illness in the 3 weeks before the first study day
  • History or presence of gastrointestinal, liver or kidney disease, or other conditions known to interfere with distribution, metabolism or excretion of study drugs
  • Blood donation during the previous 3 weeks
  • Ametropy >= 3 dpt
  • Acute gastric bleeding, massive cerebral hemorrhage related to stroke
  • Women: pregnancy or lactation
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): NCT00709423


Locations
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Austria
Department of Clincal Pharmacology, Medical University of Vienna
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
Investigators
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Principal Investigator: Michael Wolzt, MD Department of Clincal Pharmacology, Medical University of Vienna
More Information
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Responsible Party: Dorothea Gross, Ursapharm, Germany
ClinicalTrials.gov Identifier: NCT00709423    
Other Study ID Numbers: OPHT-161106
First Posted: July 3, 2008    Key Record Dates
Last Update Posted: July 3, 2008
Last Verified: June 2008
Additional relevant MeSH terms:
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Moxaverine
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs