Status:
WITHDRAWN
Effect of Rosuvastatin on Endothelial Function in Patients With Diabetes and Glaucoma
Lead Sponsor:
Medical University of Vienna
Conditions:
Glaucoma
Diabetes
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 im...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2014
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00913562
Start Date
June 1 2009
End Date
November 1 2014
Last Update
November 21 2014
Active Locations (1)
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1
Department of Clinical Pharmacology, Medical University of Vienna
Vienna, Austria, 1090