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

History of Changes

Tracking Information

First Received Date ^ICMJE

July 1, 2008

Last Updated Date

July 2, 2008

Start Date ^ICMJE

March 2007

Primary Completion Date

May 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00709423 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Effects of Moxaverine and Placebo on Ocular Blood Flow

Official Title ^ICMJE

A Randomized, Double-Masked, Placebo-Controlled Two Cross Over Study Comparing the Effects of Moxaverine and Placebo on Ocular Blood Flow

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Regional Blood Flow
Ocular Physiology
Retina

Intervention ^ICMJE

Drug: Moxaverine
Drug: Moxaverin 150mg
intravenous administration

Other Name: Collateral i
Drug: NaCl
intravenous administration

Study Arm (s)

Active Comparator: 1
Interventions:
- Drug: Moxaverine
- Drug: Moxaverin 150mg
Placebo Comparator: 2
Intervention: Drug: NaCl

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

May 2007

Primary Completion Date

May 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 35 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Austria

Administrative Information

NCT Number ^ICMJE

NCT00709423

Other Study ID Numbers ^ICMJE

OPHT-161106

Has Data Monitoring Committee

Yes

Responsible Party

Dorothea Gross, Ursapharm, Germany

Study Sponsor ^ICMJE

Medical University of Vienna

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Michael Wolzt, MD

Department of Clincal Pharmacology, Medical University of Vienna

Information Provided By

Medical University of Vienna

Verification Date

June 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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