Effect of Rosuvastatin on Endothelial Function in Patients With Diabetes and Glaucoma

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 Overview

• Status: Withdrawn
• Conditions: Glaucoma; Diabetes
• Intervention / Treatment: Drug: Rosuvastatin; Drug: Placebo

• Study Type: Interventional
• Phase: Phase 4

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria, 1090
    • Department of Clinical Pharmacology, Medical University of Vienna

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Patients with diabetes; Rosuvastatin	Drug: Rosuvastatin; one tablet rosuvastatin 10 mg per day for 12 weeks
Active Comparator: Patients with glaucoma; Rosuvastatin	Drug: Rosuvastatin; one tablet rosuvastatin 10 mg per day for 12 weeks
Placebo Comparator: Control patients with diabetes; Placebo	Drug: Placebo; one tablet a day for 12 weeks
Placebo Comparator: Control patients with glaucoma; Placebo	Drug: Placebo; one tablet a day for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Flicker induced vasodilatation	10 minutes blood flow measurements on 3 study days - up to12 weeks of treatment with rosuvastatin

Collaborators and Investigators

• Sponsor: Medical University of Vienna

Study record dates

Study Major Dates

• Study Start: June 1, 2009
• Primary Completion (Actual): November 1, 2014
• Study Completion (Actual): November 1, 2014

Study Registration Dates

• First Submitted: June 3, 2009
• First Submitted That Met QC Criteria: June 3, 2009
• First Posted (Estimate): June 4, 2009

Study Record Updates

• Last Update Posted (Estimate): November 21, 2014
• Last Update Submitted That Met QC Criteria: November 20, 2014
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Keywords: Regional Blood Flow; Ocular Physiology
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Eye Diseases; Endocrine System Diseases; Ocular Hypertension; Glaucoma; Diabetes Mellitus; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Rosuvastatin Calcium
• Other Study ID Numbers: OPHT-040908