Atorvastatin for the Treatment of Retinal Vein Occlusion

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

Detailed Description
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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.

Official Title
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Atorvastatin Toronto Retinal Vein Occlusion Study (ATORVO)

Conditions
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Retinal Vein Occlusion, Retinal Vein Thrombosis, Central Retinal Vein Occlusion, Branch Retinal Vein Occlusion, Thrombosis

Intervention / Treatment
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* Drug: Atorvastatin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Atorvastatin 80 mg orally once daily for 24 weeks | Drug: Atorvastatin<br>* 80 mg orally once daily for 24 weeks<br>* Other names: Lipitor;|
| Placebo Comparator: P<br>Placebo tablet orally once daily for 24 weeks | Drug: Placebo<br>* Placebo tablet orally once daily for 24 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | 24 weeks | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Retinal vein occlusion, Retinal vein thrombosis, Central retinal vein occlusion, Branch retinal vein occlusion, Visual loss, Atorvastatin, Statin, Neovascularization, Thrombosis