Macular DegenerationPhase 2/3NCT00709449
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
A Phase 2/3 study testing moxaverine in people with Macular Degeneration and Glaucoma, run by Medical University of Vienna at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Macular Degeneration, Glaucoma, Regional Blood Flow
- What is being tested?
- moxaverine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteAustria
- Study dates
- May 2008to Mar 2009
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 15Show fewer
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Austria1 site
Department of Clinical Pharmacology, Medical University of Vienna
Vienna, 1090
About this study
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.
- Conditions
- Macular Degeneration, Glaucoma, Regional Blood Flow
- Being tested
- moxaverine
- Keywords
- Age-related macular degeneration, Glaucoma
- Medical subject headings
- Macular Degeneration, Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
moxaverineDrug
Also called Collateral i
intravenous infusion of 150 mg in 250 ml NaCl, applied over 30 minutes.
moxaverineDrug
Also called Collateral i
intravenous infusion of 150 mg in 250 ml NaCl, applied over 30 minutes.
moxaverineDrug
Also called Collateral i
intravenous infusion of 150 mg in 250 ml NaCl, applied over 30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 20 patients with age related macular degeneration Receives: Drug: moxaverine |
| 2 | Experimental | 20 patients with primary open angle glaucoma Receives: Drug: moxaverine |
| 3 | Experimental | 20 age and sex matched control subjects Receives: Drug: moxaverine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Choroidal and optic nerve head blood flow
Measured: 2 hours
Secondary outcomes (5)
Retrobulbar flow velocities
Measured: 2 hours
Retinal blood flow velocity
Measured: 2 hours
Retinal venous and arterial diameters
Measured: 2 hours
Intraocular pressure
Measured: 2 hours
Systolic and diastolic blood pressure
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2008 (estimated)
- Study startMay 2008
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Macular DegenerationStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00709449
- Sponsor's protocol ID
- OPHT-011007
- Status last verified
- Nov 2009
- First submitted
- 27 Jun 2008
- Last updated
- 1 Dec 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00709449
- Acronym / sponsor ID
- OPHT-011007
- Conditions
- Macular Degeneration, Glaucoma, Regional Blood Flow
- Keywords
- Age-related macular degeneration, Glaucoma
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 3 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: moxaverine20 patients with age related macular degeneration |
| 2 | Experimental | Drug: moxaverine20 patients with primary open angle glaucoma |
| 3 | Experimental | Drug: moxaverine20 age and sex matched control subjects |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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
- Patients with nonexudative AMD
- Visual acuity in the study eye > 20/60
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| moxaverineAlso: Collateral iintravenous infusion of 150 mg in 250 ml NaCl, applied over 30 minutes. | Drug | 1 |
| moxaverineAlso: Collateral iintravenous infusion of 150 mg in 250 ml NaCl, applied over 30 minutes. | Drug | 2 |
| moxaverineAlso: Collateral iintravenous infusion of 150 mg in 250 ml NaCl, applied over 30 minutes. | Drug | 3 |
Primary outcome
Choroidal and optic nerve head blood flow
Time frame: 2 hours
5 secondary outcomes
Retrobulbar flow velocities
Time frame: 2 hours
Retinal blood flow velocity
Time frame: 2 hours
Retinal venous and arterial diameters
Time frame: 2 hours
Intraocular pressure
Time frame: 2 hours
Systolic and diastolic blood pressure
Time frame: 2 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing moxaverine in people with Macular Degeneration and Glaucoma, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Choroidal and optic nerve head blood flow (time frame: 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2009.