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An Open Study Comparing the Effects of Moxaverine on Ocular Blood Flow in Patients With Age- Related Macular Degeneration, Primary Open Angle Glaucoma and Healthy Control Subjects

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Medical University of Vienna

Status and phase

Completed
Phase 3
Phase 2

Conditions

Macular Degeneration
Regional Blood Flow
Glaucoma

Treatments

Drug: moxaverine

Study type

Interventional

Funder types

Other

Identifiers

NCT00709449
OPHT-011007

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 a recent study the investigators have shown that intravenous moxaverine increases choroidal blood flow in healthy young subjects. The present study aims to investigate, whether moxaverine also improves blood flow in the diseased eye after systemic administration.

Enrollment

60 estimated patients

Sex

All

Ages

50+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Men and women aged over 50 years
  • Ametropia of less than 6 diopters and anisometropia of less than 2 diopters
  • Clear non-lenticular ocular media

AMD patients:

  • Patients with nonexudative AMD
  • Visual acuity in the study eye > 20/60

Glaucoma patients:

  • Unilateral or bilateral primary open angle glaucoma
  • At least 3 reliable visual field testings
  • Treated intraocular pressure < 21 mmHg,
  • Visual field mean deviation MD <10 (Humphrey 30-2)

Healthy control subjects:

  • Age- , gender- and sex- matched to the two patient groups,
  • Matched with regard to smoking habits of the two patient group
  • No observable eye diseases

Exclusion criteria

  • 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
  • Abuse of alcoholic beverages or drugs, participation in a clinical trial in the 3 weeks preceding the study
  • Known diabetes mellitus
  • Presence of any ocular pathology that interferes with the aims of the present study
  • Intraocular surgery within the last 3 weeks
  • Hypersensitivity to moxaverine
  • Acute gastric bleeding, massive cerebral hemorrhage related to stroke

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

60 participants in 3 patient groups

1
Experimental group
Description:
20 patients with age related macular degeneration
Treatment:
Drug: moxaverine
Drug: moxaverine
Drug: moxaverine
2
Experimental group
Description:
20 patients with primary open angle glaucoma
Treatment:
Drug: moxaverine
Drug: moxaverine
Drug: moxaverine
3
Experimental group
Description:
20 age and sex matched control subjects
Treatment:
Drug: moxaverine
Drug: moxaverine
Drug: moxaverine

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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