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Atorvastatin for the Treatment of Retinal Vein Occlusion (ATORVO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00517257
Recruitment Status : Unknown
Verified June 2008 by University of Toronto.
Recruitment status was:  Recruiting
First Posted : August 16, 2007
Last Update Posted : June 25, 2008
St. Michael's Hospital, Toronto
Canadian Heart Research Centre
Ontario Association of Optometrists
Toronto Ophthalmological Society
Information provided by:
University of Toronto

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

Condition or disease Intervention/treatment Phase
Retinal Vein Occlusion Retinal Vein Thrombosis Central Retinal Vein Occlusion Branch Retinal Vein Occlusion Thrombosis Drug: Atorvastatin Drug: Placebo Phase 3

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Atorvastatin Toronto Retinal Vein Occlusion Study (ATORVO)
Study Start Date : August 2007
Estimated Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: A
Atorvastatin 80 mg orally once daily for 24 weeks
Drug: Atorvastatin
80 mg orally once daily for 24 weeks
Other Name: Lipitor

Placebo Comparator: P
Placebo tablet orally once daily for 24 weeks
Drug: Placebo
Placebo tablet orally once daily for 24 weeks

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Prevention of ocular neovascularization or need for laser treatment by 24 weeks. [ Time Frame: 24 weeks ]
  2. Reduction in macular edema, measured by optical coherence tomography at 24 weeks. [ Time Frame: 24 weeks ]
  3. 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 ]
  4. 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 ]
  5. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00517257

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Contact: Brigita Zile Zile, RN 416-864-6060 ext 4130
Contact: Joel Ray, MD MSc 416-864-6060 ext 6752

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Canada, Ontario
St. Michael's Hospital Recruiting
Toronto, Ontario, Canada, M5B 1W8
Contact: Brigita Zile, RN CCRP    416-864-6060 ext 4130   
Principal Investigator: Joel G Ray, MD MSc         
Principal Investigator: David T Wong, MD         
Sub-Investigator: Larry Leiter, MD         
Sub-Investigator: Shaun Goodman, MD MSc         
Sub-Investigator: Anatoly Langer, MD         
Sponsors and Collaborators
University of Toronto
St. Michael's Hospital, Toronto
Canadian Heart Research Centre
Ontario Association of Optometrists
Toronto Ophthalmological Society
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Principal Investigator: Joel G Ray, MD MSc St. Michael's Hospital, University of Toronto
Principal Investigator: David Wong, MD St. Michael's Hospital, University of Toronto
Layout table for additonal information Identifier: NCT00517257    
Other Study ID Numbers: NRA2580025
First Posted: August 16, 2007    Key Record Dates
Last Update Posted: June 25, 2008
Last Verified: June 2008
Keywords provided by University of Toronto:
Retinal vein occlusion
Retinal vein thrombosis
Central retinal vein occlusion
Branch retinal vein occlusion
Visual loss
Additional relevant MeSH terms:
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Retinal Vein Occlusion
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Retinal Diseases
Eye Diseases
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors