The ATORVO study is designed to determine whether atorvastatin (Lipitor) can improve vision, when compared to placebo
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
180
80 mg orally once daily for 24 weeks
Placebo tablet orally once daily for 24 weeks
St. Michael's Hospital
Toronto, Ontario, Canada
RECRUITINGDifference 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
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
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