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

• ClinicalTrials.gov Identifier: NCT00913562
• Recruitment Status: Withdrawn
• First Posted: June 4, 2009
• Last Update Posted: November 21, 2014
• Sponsor: Medical University of Vienna
• Information provided by: Medical University of Vienna

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.

Condition or disease	Intervention/treatment	Phase
Glaucoma; Diabetes	Drug: Rosuvastatin; Drug: Placebo	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 0 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Basic Science
• Official Title: Effect of Rosuvastatin on Endothelial Function in Patients With Diabetes and Glaucoma
• Study Start Date: June 2009
• Actual Primary Completion Date: November 2014
• Actual Study Completion Date: November 2014

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Flicker induced vasodilatation [ Time Frame: 10 minutes blood flow measurements on 3 study days - up to12 weeks of treatment with rosuvastatin ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

Austria

Department of Clinical Pharmacology, Medical University of Vienna

Vienna, Austria, 1090

Sponsors and Collaborators

Medical University of Vienna

Investigators

• Principal Investigator: Gerhard Garhofer, MD; Medical University of Vienna

More Information

• Responsible Party: Gerhard Garhofer, Medical University of Vienna
• ClinicalTrials.gov Identifier: NCT00913562
• Other Study ID Numbers: OPHT-040908
• First Posted: June 4, 2009
• Last Update Posted: November 21, 2014
• Last Verified: November 2014

Keywords provided by Medical University of Vienna:

Ocular Physiology; Regional Blood Flow

Additional relevant MeSH terms:

Glaucoma; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Ocular Hypertension; Eye Diseases; Rosuvastatin Calcium; Anticholesteremic Agents; Hypolipidemic Agents; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Enzyme Inhibitors