Title
Atorvastatin for the Treatment of Retinal Vein Occlusion
Atorvastatin Toronto Retinal Vein Occlusion Study (ATORVO)
Phase
Phase 3Lead Sponsor
University of TorontoStudy Type
InterventionalStatus
Unknown statusIndication/Condition
Branch Retinal Vein Occlusion Thrombosis ...Intervention/Treatment
atorvastatin ...Study Participants
180The 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.
80 mg orally once daily for 24 weeks
Placebo tablet orally once daily for 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.
