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

Phase 4

Withdrawn

• Conditions: Diabetes; Glaucoma
• Interventions: Drug: Placebo; Drug: Rosuvastatin

• Registration Number: NCT00913562
• Lead Sponsor: Medical University of Vienna

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2009-06-03
• Study First Submitted QC: 2009-06-03
• Study First Posted: 2009-06-04
• Status Verified: 2014-11
• Primary Completion: 2014-11
• Study Completion: 2014-11
• Last Update Submitted: 2014-11-20
• Last Update Posted: 2014-11-21

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control patients with glaucoma	Placebo	Placebo
Patients with diabetes	Rosuvastatin	Rosuvastatin
Patients with glaucoma	Rosuvastatin	Rosuvastatin
Control patients with diabetes	Placebo	Placebo

Primary Outcome Measures

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

Trial Locations

Locations (1)

Department of Clinical Pharmacology, Medical University of Vienna; 🇦🇹 Vienna, Austria