GlaucomaPhase 4NCT00913562
Effect of Rosuvastatin on Endothelial Function in Patients With Diabetes and Glaucoma
A Phase 4 study testing Rosuvastatin in people with Glaucoma and Diabetes, run by Medical University of Vienna at 1 site in Austria.
Trial summary
Endothelial dysfunction can be seen in a variety of vascular related ocular diseases such as glaucoma or diabetic retinopathy. There is accumulating evidence now that statins may at least partially improve endothelial function in several vascular beds, an effect that is probably independent of the lipid lowering… Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Rosuvastatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteAustria
- Study dates
- Jun 2009to Nov 2014
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diabetes patients:
- Men and women aged over 18 years.
- subjects with both hypercholesterolemia and normal lipid profile will be included.
- Diabetes type I or type II. Only patients with no signs of diabetic retinopathy (level 1) or patients with mild or moderate diabetic retinopathy will be included. Level of diabetic retinopathy will be assessed according to the modified Airlie House classification (1991).
- Normal laboratory values unless the investigator considers an abnormality to be clinically irrelevant.
- Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant.
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- -Normal ophthalmic findings, except diabetic retinopathy as described above, ametropia < 6 Dpt.
- Glaucoma patients:
- Men and women aged over 18 years.
- Subjects with both hypercholesterolemia and normal lipid profile will be included.
- Open angle glaucoma defined as pathological optic disc appearance and characteristic visual field loss. Visual field loss is defined as having a glaucoma hemifield test outside normal limits and/or a CPSD with P < 0.05 (Keltner et al. 2003).
- Normal laboratory values unless the investigator considers an abnormality to be clinically irrelevant.
- Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant.
- Normal ophthalmic findings, except glaucoma as described above, ametropia < 6 Dpt.
- sufficiently controlled intraocular pressure.
Who cannot join
- Abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study.
- Symptoms of a clinically relevant illness in the 3 weeks before the first study day.
- Previous or current treatment with statins.
- Current treatment with fibrates.
- History or presence of renal failure, creatine kinase (CK) and lactic dehydrogenase (LDH) above normal levels.
- History or presence of hepatic dysfunction, including increase of liver enzymes.
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- Patients with known hypersensitivity to the study drug or any ingredients.
- Patients with or with a history of myopathy.
- Systemic treatment with oral anticoagulants except low dose aspirin.
- Blood donation during the previous 3 weeks.
- Ametropia of 6 or more than 6 dpt.
- Presence of intraocular pathology other than non proliferative diabetic retinopathy for cohort I and glaucoma for cohort II.
- Ophthalmological surgery (including argon laser trabeculoplasty (ALT), trabeculectomy, deep sclerectomy) within the last 6 months before the study.
- History or family history of epilepsy.
- Pregnancy.
Trial locations and contacts
1 site in 1 country.
Austria1 site
Department of Clinical Pharmacology, Medical University of Vienna
Vienna, 1090
About this study
Endothelial dysfunction can be seen in a variety of vascular related ocular diseases such as glaucoma or diabetic retinopathy. There is accumulating evidence now that statins may at least partially improve endothelial function in several vascular beds, an effect that is probably independent of the lipid lowering effects of the statins.
Consequently, the current study seeks to investigate whether administration of 10 mg rosuvastatin by mouth (p.o.) for 12 weeks can improve the endothelial function in patients with glaucoma and diabetic retinopathy. For this purpose, flow mediated vasodilatation of the brachial artery and flicker induced vasodilatation of retinal vessels will be measured at baseline, after 6 and 12 weeks of treatment with rosuvastatin.
- Being tested
- Rosuvastatin, Placebo
- Keywords
- Ocular Physiology, Regional Blood Flow
- Medical subject headings
- Glaucoma, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RosuvastatinDrug
one tablet rosuvastatin 10 mg per day for 12 weeks
PlaceboDrug
one tablet a day for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Patients with diabetes | Active comparator | Rosuvastatin Receives: Drug: Rosuvastatin |
| Patients with glaucoma | Active comparator | Rosuvastatin Receives: Drug: Rosuvastatin |
| Control patients with diabetes | Placebo comparator | Placebo Receives: Drug: Placebo |
| Control patients with glaucoma | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Flicker induced vasodilatation
Measured: 10 minutes blood flow measurements on 3 study days - up to12 weeks of treatment with rosuvastatin
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2009 (estimated)
- Study startJun 2009
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies 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 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Investigators
- Gerhard Garhofer, MD, Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00913562
- Sponsor's protocol ID
- OPHT-040908
- Status last verified
- Nov 2014
- First submitted
- 3 Jun 2009
- Last updated
- 21 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Rosuvastatin on Endothelial Function in Patients With Diabetes and Glaucoma
- ClinicalTrials.gov ID
- NCT00913562
- Acronym / sponsor ID
- OPHT-040908
- Keywords
- Ocular Physiology, Regional Blood Flow
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 4 Jun 2009 (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.
Endothelial dysfunction can be seen in a variety of vascular related ocular diseases such as glaucoma or diabetic retinopathy. There is accumulating evidence now that statins may at least partially improve endothelial function in several vascular beds, an effect that is probably independent of the lipid lowering effects of the statins.
Consequently, the current study seeks to investigate whether administration of 10 mg rosuvastatin by mouth (p.o.) for 12 weeks can improve the endothelial function in patients with glaucoma and diabetic retinopathy. For this purpose, flow mediated vasodilatation of the brachial artery and flicker induced vasodilatation of retinal vessels will be measured at baseline, after 6 and 12 weeks of treatment with rosuvastatin.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Patients with diabetes | Active comparator | Drug: RosuvastatinRosuvastatin |
| Patients with glaucoma | Active comparator | Drug: RosuvastatinRosuvastatin |
| Control patients with diabetes | Placebo comparator | Drug: PlaceboPlacebo |
| Control patients with glaucoma | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Men and women aged over 18 years.
- subjects with both hypercholesterolemia and normal lipid profile will be included.
- Diabetes type I or type II. Only patients with no signs of diabetic retinopathy (level 1) or patients with mild or moderate diabetic retinopathy will be included. Level of diabetic retinopathy will be assessed according to the modified Airlie House classification (1991).
- Normal laboratory values unless the investigator considers an abnormality to be clinically irrelevant.
- Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant.
Key exclusion criteria (15 listed)
- Abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study.
- Symptoms of a clinically relevant illness in the 3 weeks before the first study day.
- Previous or current treatment with statins.
- Current treatment with fibrates.
- History or presence of renal failure, creatine kinase (CK) and lactic dehydrogenase (LDH) above normal levels.
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 |
|---|---|---|
| Rosuvastatinone tablet rosuvastatin 10 mg per day for 12 weeks | Drug | Patients with diabetes, Patients with glaucoma |
| Placeboone tablet a day for 12 weeks | Drug | Control patients with diabetes, Control patients with glaucoma |
Primary outcome
Flicker induced vasodilatation
Time frame: 10 minutes blood flow measurements on 3 study days - up to12 weeks of treatment with rosuvastatin
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2014.
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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.
Gerhard Garhofer, MD principal investigator
Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rosuvastatin in people with Glaucoma and Diabetes, 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 15 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: withdrawn, as of the sponsor's last update on 21 Nov 2014. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 was withdrawn before enrolling participants, so there are no results.
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?
Flicker induced vasodilatation (time frame: 10 minutes blood flow measurements on 3 study days - up to12 weeks of treatment with rosuvastatin). 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 21 Nov 2014.