Official Title: “Atorvastatin Toronto Retinal Vein Occlusion Study (ATORVO)”

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

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

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.

Intervention(s) in this Clinical Trial

• Drug: Atorvastatin
  • 80 mg orally once daily for 24 weeks
• Drug: Placebo
  • Placebo tablet orally once daily for 24 weeks

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: A
  • Atorvastatin 80 mg orally once daily for 24 weeks
• Placebo Comparator: P
  • Placebo tablet orally once daily for 24 weeks

Primary Measures

• Difference in improvement of at least 15 letters (3 lines) in Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity in the affected eye at 24 weeks in patients on active treatment vs. placebo.
  • Time Frame: 24 weeks
    

Secondary Measures

• Prevention of ocular neovascularization or need for laser treatment by 24 weeks.
  • Time Frame: 24 weeks
    
• Reduction in macular edema, measured by optical coherence tomography at 24 weeks.
  • Time Frame: 24 weeks
    
• Mean change in The National Eye Institute 25-Item Visual Function Questionnaire-25 (VFQ-25) score from 0 to 24 weeks.
  • Time Frame: 24 weeks
    
• Composite of non-fatal myocardial infarction, hospitalization for acute coronary syndrome, receipt of coronary revascularization, stroke or death, by 52 weeks.
  • Time Frame: 24 weeks
    
• Mean change in the concentration of serum total cholesterol, LDL-cholesterol and highly sensitive C-reactive protein at 0 and 24 weeks.
  • Time Frame: 24 weeks
    

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 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 macular hole, 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 to screening
• Known allergy to fluorescein dye
• Current use of cyclosporine medication.
• Current use of an HIV protease inhibitor medication.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 40 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: University of Toronto

Overall Clinical Trial Officials and Contacts

Joel G Ray, MD MSc Principal Investigator St. Michael's Hospital, University of Toronto  

Overall Contact: Brigita Zile Zile, RN 416-864-6060 zileb@smh.toronto.on.ca

Information obtained from ClinicalTrials.gov on August 28, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00517257

Study ID Number: NRA2580025

ClinicalTrials.gov Identifier: NCT00517257

Health Authority: Canada: Health Canada