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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by Medical University of Vienna.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT00913562
First received: June 3, 2009
Last updated: NA
Last verified: June 2009
History: No changes posted
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 - baseline, after 6 and 12 weeks of treatment with rosuvastatin ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: June 2009
Estimated Study Completion Date: June 2010
Estimated Primary Completion Date: April 2010 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Gerhard Garhofer, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT00913562     History of Changes
Other Study ID Numbers: OPHT-040908
Study First Received: June 3, 2009
Last Updated: June 3, 2009
Health Authority: Austria: Agency for Health and Food Safety

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
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 18, 2014