Back to resultsEffect of Rosuvastatin on Endothelial Function in Patients With Diabetes and Glaucoma
Primary Purpose
Glaucoma, Diabetes
Status
Withdrawn
Phase
Phase 4
Locations
Austria
Study Type
Interventional
Intervention
Rosuvastatin
Placebo
Sponsored by
About this trial
This is an interventional basic science trial for Glaucoma focused on measuring Ocular Physiology, Regional Blood Flow
Eligibility Criteria
Inclusion Criteria:
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.
- -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.
Exclusion Criteria:
- 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.
- 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.
Sites / Locations
- Department of Clinical Pharmacology, Medical University of Vienna
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Placebo Comparator
Placebo Comparator
Arm Label
Patients with diabetes
Patients with glaucoma
Control patients with diabetes
Control patients with glaucoma
Arm Description
Rosuvastatin
Rosuvastatin
Placebo
Placebo
Outcomes
Primary Outcome Measures
Flicker induced vasodilatation
Secondary Outcome Measures
Full Information
NCT ID
NCT00913562
First Posted
June 3, 2009
Last Updated
November 20, 2014
Sponsor
Medical University of Vienna
1. Study Identification
Unique Protocol Identification Number
NCT00913562
Brief Title
Effect of Rosuvastatin on Endothelial Function in Patients With Diabetes and Glaucoma
Official Title
Effect of Rosuvastatin on Endothelial Function in Patients With Diabetes and Glaucoma
Study Type
Interventional
2. Study Status
Record Verification Date
November 2014
Overall Recruitment Status
Withdrawn
Study Start Date
June 2009 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
November 2014 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Medical University of Vienna
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Diabetes
Keywords
Ocular Physiology, Regional Blood Flow
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients with diabetes
Arm Type
Active Comparator
Arm Description
Rosuvastatin
Arm Title
Patients with glaucoma
Arm Type
Active Comparator
Arm Description
Rosuvastatin
Arm Title
Control patients with diabetes
Arm Type
Placebo Comparator
Arm Description
Placebo
Arm Title
Control patients with glaucoma
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Rosuvastatin
Intervention Description
one tablet rosuvastatin 10 mg per day for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
one tablet a day for 12 weeks
Primary Outcome Measure Information:
Title
Flicker induced vasodilatation
Time Frame
10 minutes blood flow measurements on 3 study days - up to12 weeks of treatment with rosuvastatin
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
-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.
Exclusion Criteria:
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.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gerhard Garhofer, MD
Organizational Affiliation
Medical University of Vienna
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Clinical Pharmacology, Medical University of Vienna
City
Vienna
ZIP/Postal Code
1090
Country
Austria
12. IPD Sharing Statement
Learn more about this trial
Effect of Rosuvastatin on Endothelial Function in Patients With Diabetes and Glaucoma
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