Atorvastatin for the Treatment of Retinal Vein Occlusion

Last updated: June 23, 2008
Sponsor: University of Toronto
Overall Status: Trial Status Unknown

Phase

3

Condition

Venous Thrombosis

Thrombosis

Venous Thromboembolism

Treatment

N/A

Clinical Study ID

NCT00517257
NRA2580025
  • Ages > 40
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The ATORVO study is designed to determine whether atorvastatin (Lipitor) can improve vision, when compared to placebo

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adults aged 40 years and older

  • Diagnosed with CRVO or BRVO

  • Visual acuity of 20/40 or worse in the affected eye

  • Onset of current symptoms of loss of vision within the past 60 days

  • Ability to understand spoken English

Exclusion

Exclusion Criteria:

  • Current use of a statin or fibrate medication

  • Known cardiovascular disease or revascularization, including coronary artery disease (myocardial infarction or angina), stroke or peripheral artery occlusion

  • Known diabetes mellitus

  • Known liver disease

  • Serum low-density lipoprotein cholesterol (LDL-C) > 5.0 mmol/L

  • Baseline serum triglycerides > 6.0 mmol/L

  • Serum ALT above 115 U/L (i.e., 2.5 x upper limit of normal)

  • Baseline serum creatinine > 250 µmol/L

  • Ocular surgery within the past 90 days

  • Planned ocular or cataract surgery within the study period

  • Known retinal disease: age-related macular degeneration, retinal detachment or macularhole, or past history of vein occlusion

  • Women who are pregnant or who are breastfeeding

  • Participation in another clinical trial concurrently or within 30 days prior toscreening

  • Known allergy to fluorescein dye

  • Current use of cyclosporine medication.

  • Current use of an HIV protease inhibitor medication.

Study Design

Total Participants: 180
Study Start date:
August 01, 2007
Estimated Completion Date:
September 30, 2009

Study Description

Retinal vein occlusion (RVO), a common cause of visual loss in the Western world, is a disease whose etiology resembles that of classic atherosclerosis. A therapy that lowers the risk of arterial and venous thrombosis would seem to be a reasonable approach to managing this disease, for which there is currently no treatment.

ATORVO is a randomized double-masked clinical trial comparing a daily dose of 80 mg of atorvastatin to matched placebo in persons recently diagnosed with RVO. At 24 weeks after randomization, we will evaluate each participant's visual acuity and the presence of secondary complications related to RVO.

Connect with a study center

  • St. Michael's Hospital

    Toronto, Ontario M5B 1W8
    Canada

    Active - Recruiting

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