NCT00709449

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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started May 2008

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 27, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 3, 2008

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

December 1, 2009

Status Verified

November 1, 2009

Enrollment Period

10 months

First QC Date

June 27, 2008

Last Update Submit

November 30, 2009

Conditions

Macular DegenerationGlaucomaRegional Blood Flow

Keywords

Age-related macular degenerationGlaucoma

Outcome Measures

Primary Outcomes (1)

  • Choroidal and optic nerve head blood flow

    2 hours

Secondary Outcomes (5)

  • Retrobulbar flow velocities

    2 hours

  • Retinal blood flow velocity

    2 hours

  • Retinal venous and arterial diameters

    2 hours

  • Intraocular pressure

    2 hours

  • Systolic and diastolic blood pressure

    2 hours

Study Arms (3)

1

EXPERIMENTAL

20 patients with age related macular degeneration

Drug: moxaverine

2

EXPERIMENTAL

20 patients with primary open angle glaucoma

Drug: moxaverine

3

EXPERIMENTAL

20 age and sex matched control subjects

Drug: moxaverine

Interventions

moxaverineDRUG

intravenous infusion of 150 mg in 250 ml NaCl, applied over 30 minutes.

Also known as: Collateral i
1

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Clinical Pharmacology, Medical University of Vienna

Vienna, 1090, Austria

Location

MeSH Terms

Conditions

Macular DegenerationGlaucoma

Interventions

moxaverine

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye DiseasesOcular Hypertension

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 27, 2008

First Posted

July 3, 2008

Study Start

May 1, 2008

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

December 1, 2009

Record last verified: 2009-11

Locations

AU(1)