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

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00913562
• Other study ID #: OPHT-040908
• Status: Withdrawn
• Phase: Phase 4
• First received: June 3, 2009
• Last updated: November 20, 2014
• Start date: June 2009
• Est. completion date: November 2014

Study information

• Verified date: November 2014
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Agency for Health and Food Safety
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Diabetes
• Glaucoma

Intervention

Drug:
• Rosuvastatin
one tablet rosuvastatin 10 mg per day for 12 weeks
• Placebo
one tablet a day for 12 weeks

Locations

Country	Name	City	State
Austria	Department of Clinical Pharmacology, Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Flicker induced vasodilatation		10 minutes blood flow measurements on 3 study days - up to12 weeks of treatment with rosuvastatin	No