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

This study has been withdrawn prior to enrollment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00913562
First Posted: June 4, 2009
Last Update Posted: November 21, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Medical University of Vienna
  Purpose

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 Intervention Phase
Glaucoma Diabetes Drug: Rosuvastatin Drug: Placebo Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Medical University of Vienna:

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

Enrollment: 0
Study Start Date: June 2009
Study Completion Date: November 2014
Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00913562


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     History of Changes
Other Study ID Numbers: OPHT-040908
First Submitted: June 3, 2009
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:
Diabetes Mellitus
Glaucoma
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