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Effects of Moxaverine and Placebo on Ocular Blood Flow

Sponsor
Medical University of Vienna (Other)
Overall Status
Completed
CT.gov ID
NCT00709423
Collaborator
(none)
16
Enrollment
1
Location
2
Arms
2
Duration (Months)
8
Patients Per Site Per Month

Study Details

Study Description

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
Phase 2

Study Design

Study Type:
Interventional
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 :
Mar 1, 2007
Actual Primary Completion Date :
May 1, 2007
Actual Study Completion Date :
May 1, 2007

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 1

Drug: Moxaverine

Drug: Moxaverin 150mg
intravenous administration
Other Names:
  • Collateral i

    		•
    Placebo Comparator: 2

    Drug: NaCl
    intravenous administration

    Outcome Measures

    Primary Outcome Measures

    1. Retinal blood flow (Laser Doppler Velocimetry, Retinal Vessel Analyzer) [2 hours]

    2. Choroidal and optic nerve head blood flow (Laser Doppler Flowmetry) [2 hours]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 35 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Locations

    Site City State Country Postal Code
    1 Department of Clincal Pharmacology, Medical University of Vienna Vienna Austria 1090

    Sponsors and Collaborators

    • Medical University of Vienna

    Investigators

    • Principal Investigator: Michael Wolzt, MD, Department of Clincal Pharmacology, Medical University of Vienna

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00709423
    Other Study ID Numbers:
    • OPHT-161106
    First Posted:
    Jul 3, 2008
    Last Update Posted:
    Jul 3, 2008
    Last Verified:
    Jun 1, 2008
    Additional relevant MeSH terms:
    Moxaverine

    Study Results

    No Results Posted as of Jul 3, 2008