Atorvastatin for the Treatment of Retinal Vein Occlusion (ATORVO)

Tracking Information
First Submitted Date ICMJE	August 14, 2007
First Posted Date ICMJE	August 16, 2007
Last Update Posted Date	June 25, 2008
Study Start Date ICMJE	August 2007
Primary Completion Date	Not Provided
Current Primary Outcome Measures ICMJE; (submitted: August 14, 2007)	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 ]
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00517257 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: August 14, 2007)	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 ]
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Atorvastatin for the Treatment of Retinal Vein Occlusion
Official Title ICMJE	Atorvastatin Toronto Retinal Vein Occlusion Study (ATORVO)
Brief Summary	The ATORVO study is designed to determine whether atorvastatin (Lipitor) can improve vision, when compared to placebo
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.
Study Type ICMJE	Interventional
Study Phase	Phase 3
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition ICMJE	Retinal Vein Occlusion; Retinal Vein Thrombosis; Central Retinal Vein Occlusion; Branch Retinal Vein Occlusion; Thrombosis
Intervention ICMJE	Drug: Atorvastatin 80 mg orally once daily for 24 weeks Other Name: Lipitor; Drug: Placebo Placebo tablet orally once daily for 24 weeks
Study Arms	Experimental: A Atorvastatin 80 mg orally once daily for 24 weeks Intervention: Drug: Atorvastatin; Placebo Comparator: P Placebo tablet orally once daily for 24 weeks Intervention: Drug: Placebo
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Unknown status
Estimated Enrollment ICMJE; (submitted: August 14, 2007)	180
Original Estimated Enrollment ICMJE	Same as current
Estimated Study Completion Date	September 2009
Primary Completion Date	Not Provided
Eligibility Criteria ICMJE	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.
Sex/Gender	Sexes Eligible for Study: All
Ages	40 Years and older (Adult, Senior)
Accepts Healthy Volunteers	Yes
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Canada
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00517257
Other Study ID Numbers ICMJE	NRA2580025
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Not Provided
Study Sponsor ICMJE	University of Toronto
Collaborators ICMJE	St. Michael's Hospital, Toronto; Pfizer; Canadian Heart Research Centre; Ontario Association of Optometrists; Toronto Ophthalmological Society
Investigators ICMJE	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
PRS Account	University of Toronto
Verification Date	June 2008
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP