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

NCT00913562 | Withdrawn Phase 4 DMC

• 1 other identifier: OPHT-040908
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Glaucoma; Diabetes

Keywords

Ocular Physiology; Regional Blood Flow

Outcome Measures

Primary Outcomes (1)

• Flicker induced vasodilatation

  10 minutes blood flow measurements on 3 study days - up to12 weeks of treatment with rosuvastatin

Study Arms (4)

Patients with diabetes

ACTIVE COMPARATOR

Rosuvastatin

Drug: Rosuvastatin

Patients with glaucoma

ACTIVE COMPARATOR

Rosuvastatin

Drug: Rosuvastatin

Control patients with diabetes

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Control patients with glaucoma

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Rosuvastatin DRUG

one tablet rosuvastatin 10 mg per day for 12 weeks

Patients with diabetes; Patients with glaucoma

Placebo DRUG

one tablet a day for 12 weeks

Control patients with diabetes; Control patients with glaucoma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Department of Clinical Pharmacology, Medical University of Vienna

Vienna, 1090, Austria

Location

MeSH Terms

Conditions

Glaucoma; Diabetes Mellitus

Interventions

Rosuvastatin Calcium

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Gerhard Garhofer, MD

  Medical University of Vienna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 3, 2009
• First Posted: June 4, 2009
• Study Start: June 1, 2009
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: November 21, 2014

Record last verified: 2014-11

Locations

AU (1)