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

Medical University of Vienna

Status and phase

Completed

Phase 2

Conditions

Effect of Orally Administrated Moxaverine on Ocular Blood Flow

Treatments

Drug: Moxaverine

Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT01629680

OPHT-080210

Details and patient eligibility

About

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.

Enrollment

16 patients

Sex

All

Ages

18 to 35 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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

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 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