Atorvastatin for the Treatment of Retinal Vein Occlusion
NCT ID: NCT00517257
Last Updated: 2008-06-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
180 participants
INTERVENTIONAL
2007-08-31
2009-09-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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A
Atorvastatin 80 mg orally once daily for 24 weeks
Atorvastatin
80 mg orally once daily for 24 weeks
P
Placebo tablet orally once daily for 24 weeks
Placebo
Placebo tablet orally once daily for 24 weeks
Interventions
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Atorvastatin
80 mg orally once daily for 24 weeks
Placebo
Placebo tablet orally once daily for 24 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
40 Years
ALL
Yes
Sponsors
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Unity Health Toronto
OTHER
Pfizer
INDUSTRY
Canadian Heart Research Centre
OTHER
Ontario Association of Optometrists
OTHER
Toronto Ophthalmological Society
UNKNOWN
University of Toronto
OTHER
Principal Investigators
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Joel G Ray, MD MSc
Role: PRINCIPAL_INVESTIGATOR
St. Michael's Hospital, University of Toronto
David Wong, MD
Role: PRINCIPAL_INVESTIGATOR
St. Michael's Hospital, University of Toronto
Locations
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St. Michael's Hospital
Toronto, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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Brigita Zile, RN CCRP
Role: primary
Other Identifiers
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NRA2580025
Identifier Type: -
Identifier Source: org_study_id