Effects of Moxaverine and Placebo on Ocular Blood Flow

This study has been completed.
Sponsor:
Information provided by:
Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT00709423
First received: July 1, 2008
Last updated: July 2, 2008
Last verified: June 2008
  Purpose

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 Intervention Phase
Regional Blood Flow
Ocular Physiology
Retina
Drug: Moxaverine
Drug: Moxaverin 150mg
Drug: NaCl
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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

Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • Retinal blood flow (Laser Doppler Velocimetry, Retinal Vessel Analyzer) [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
  • Choroidal and optic nerve head blood flow (Laser Doppler Flowmetry) [ Time Frame: 2 hours ] [ Designated as safety issue: No ]

Enrollment: 16
Study Start Date: March 2007
Study Completion Date: May 2007
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Drug: Moxaverine Drug: Moxaverin 150mg
intravenous administration
Other Name: Collateral i
Placebo Comparator: 2 Drug: NaCl
intravenous administration

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Both
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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Please refer to this study by its ClinicalTrials.gov identifier: NCT00709423

Locations
Austria
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
  More Information

No publications provided

Responsible Party: Dorothea Gross, Ursapharm, Germany
ClinicalTrials.gov Identifier: NCT00709423     History of Changes
Other Study ID Numbers: OPHT-161106
Study First Received: July 1, 2008
Last Updated: July 2, 2008
Health Authority: Austria: Agency for Health and Food Safety

Additional relevant MeSH terms:
Moxaverine
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014