A Randomized, Placebo-controlled Study Investigating the Effects of Moxaverine on Ocular Blood Flow After Oral Administration in Healthy Subjects

NCT01629680 | Completed Phase 2 DMC

• 1 other identifier: OPHT-080210
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

A number of common eye diseases such as age-related macular degeneration and glaucoma 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. For many years, moxaverine has been used in the therapy of perfusion abnormalities in the brain, the heart and the extremities. This is based on a direct vasodilatatory effect of the drug, but also on the rheological properties of red blood cells. In two recent studies the investigators have shown that intravenous moxaverine increases choroidal and retrobulbar blood flow in healthy young subjects, in elderly people with healthy eyes and in patients with eye diseases associated with hypoperfusion. The present study aims to investigate, whether ocular blood flow is also improved after oral administration of moxaverine.

Conditions

Effect of Orally Administrated Moxaverine on Ocular Blood Flow

Keywords

moxaverine; ocular blood flow

Outcome Measures

Primary Outcomes (1)

• Choroidal and optic nerve head blood flow

  Change in choroidal and optic nerve head blood flow after administration of moxaverine compared to placebo (measured before administration and 6 hours after administration)

  2 weeks

Secondary Outcomes (1)

• Retrobulbar flow velocities

  2 weeks

Study Arms (2)

Healthy subjects I

EXPERIMENTAL

Drug: Moxaverine

Healthy subjects II

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Moxaverine DRUG

Moxaverine-hydrochloride, coated tablets containing 150 mg moxaverine (Kollateral forte, Ursapharm. Saarbrücken, Germany), dosage: 900 mg, administrated per os in three equal doses of 300 mg at two hour intervals

Healthy subjects I

Placebo DRUG

coated tablets identical in number and appearance as the study drug

Healthy subjects II

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, nonsmoker
• Body mass index between 16 and 30 kg/m²
• 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, ametropia \< 6 dpt, anisometropia \< 2 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 the study drug
• Blood donation during the previous 3 weeks
• Presence of any ocular pathology that interferes with the aims of the present study
• Hypersensitivity to moxaverine
• 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 Clinical Pharmacology, Medical University of Vienna

Vienna, 1090, Austria

Location

MeSH Terms

Interventions

moxaverine

Study Officials

• Gerhard Garhoefer, MD

  Department of Clinical Pharmacology, Medical University of Vienna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Prof. PD Dr

Study Record Dates

• First Submitted: June 11, 2012
• First Posted: June 27, 2012
• Study Start: October 1, 2010
• Primary Completion: March 1, 2011
• Study Completion: June 1, 2011
• Last Updated: June 27, 2012

Record last verified: 2012-06

Locations

AU (1)