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Atorvastatin for the Treatment of Retinal Vein Occlusion (ATORVO)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2008 by University of Toronto.
Recruitment status was:  Recruiting
Sponsor:
Collaborators:
St. Michael's Hospital, Toronto
Pfizer
Canadian Heart Research Centre
Ontario Association of Optometrists
Toronto Ophthalmological Society
Information provided by:
University of Toronto
ClinicalTrials.gov Identifier:
NCT00517257
First received: August 14, 2007
Last updated: June 23, 2008
Last verified: June 2008
History of Changes
August 14, 2007
June 23, 2008
August 2007
Not Provided
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 ]
Same as current
Complete list of historical versions of study NCT00517257 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Atorvastatin for the Treatment of Retinal Vein Occlusion
Atorvastatin Toronto Retinal Vein Occlusion Study (ATORVO)
The 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.
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Retinal Vein Occlusion
  • Retinal Vein Thrombosis
  • Central Retinal Vein Occlusion
  • Branch Retinal Vein Occlusion
  • Thrombosis
  • Drug: Atorvastatin
    80 mg orally once daily for 24 weeks
    Other Name: Lipitor
  • Drug: Placebo
    Placebo tablet orally once daily for 24 weeks
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
180
September 2009
Not Provided

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.
Sexes Eligible for Study: All
40 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
 
NCT00517257
NRA2580025
Yes
Not Provided
Not Provided
Not Provided
University of Toronto
  • St. Michael's Hospital, Toronto
  • Pfizer
  • Canadian Heart Research Centre
  • Ontario Association of Optometrists
  • Toronto Ophthalmological Society
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
University of Toronto
June 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP