Effects of Moxaverine and Placebo on Ocular Blood Flow

NCT00709423 | Completed Phase 2 DMC

• 1 other identifier: OPHT-161106
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Regional Blood Flow; Ocular Physiology; Retina

Outcome Measures

Primary Outcomes (2)

• Retinal blood flow (Laser Doppler Velocimetry, Retinal Vessel Analyzer)

  2 hours

• Choroidal and optic nerve head blood flow (Laser Doppler Flowmetry)

  2 hours

Study Arms (2)

1

ACTIVE COMPARATOR

Drug: Moxaverine; Drug: Moxaverin 150mg

2

PLACEBO COMPARATOR

Drug: NaCl

Interventions

Moxaverine DRUG

1

Moxaverin 150mg DRUG

intravenous administration

Also known as: Collateral i

1

NaCl DRUG

intravenous administration

2

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Department of Clincal Pharmacology, Medical University of Vienna

Vienna, 1090, Austria

Location

MeSH Terms

Interventions

moxaverine

Study Officials

• Michael Wolzt, MD

  Department of Clincal Pharmacology, Medical University of Vienna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 1, 2008
• First Posted: July 3, 2008
• Study Start: March 1, 2007
• Primary Completion: May 1, 2007
• Study Completion: May 1, 2007
• Last Updated: July 3, 2008

Record last verified: 2008-06

Locations

AU (1)