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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Macular Degeneration, Glaucoma, Regional Blood Flow

Intervention / Treatment
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* Drug: moxaverine
* Drug: moxaverine
* Drug: moxaverine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>20 patients with age related macular degeneration | Drug: moxaverine<br>* intravenous infusion of 150 mg in 250 ml NaCl, applied over 30 minutes.<br>* Other names: Collateral i;|
| Experimental: 2<br>20 patients with primary open angle glaucoma | Drug: moxaverine<br>* intravenous infusion of 150 mg in 250 ml NaCl, applied over 30 minutes.<br>* Other names: Collateral i;|
| Experimental: 3<br>20 age and sex matched control subjects | Drug: moxaverine<br>* intravenous infusion of 150 mg in 250 ml NaCl, applied over 30 minutes.<br>* Other names: Collateral i;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Choroidal and optic nerve head blood flow |  | 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Age-related macular degeneration, Glaucoma