Effects of Moxaverine and Placebo on Ocular Blood Flow

Regional Blood Flow Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00709423
• Other study ID #: OPHT-161106
• Status: Completed
• Phase: Phase 2
• First received: July 1, 2008
• Last updated: July 2, 2008
• Start date: March 2007
• Est. completion date: May 2007

Study information

• Verified date: June 2008
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Agency for Health and Food Safety
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: May 2007
• Est. primary completion date: May 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 35 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Ocular Physiology
• Regional Blood Flow
• Retina

Intervention

Drug:
• Moxaverine

• Moxaverin 150mg
intravenous administration
• NaCl
intravenous administration

Locations

Country	Name	City	State
Austria	Department of Clincal Pharmacology, Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Retinal blood flow (Laser Doppler Velocimetry, Retinal Vessel Analyzer)		2 hours	No
Primary	Choroidal and optic nerve head blood flow (Laser Doppler Flowmetry)		2 hours	No