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Atorvastatin for the Treatment of Retinal Vein Occlusion (ATORVO)

This study is currently recruiting participants.
Verified by University of Toronto, June 2008

Sponsors and Collaborators: University of Toronto
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
  Purpose

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


Condition Intervention Phase
Retinal Vein Occlusion
Retinal Vein Thrombosis
Central Retinal Vein Occlusion
Branch Retinal Vein Occlusion
Thrombosis
Drug: Atorvastatin
Drug: Placebo
Phase III

ChemIDplus related topics:   Atorvastatin    Atorvastatin calcium   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:   Atorvastatin Toronto Retinal Vein Occlusion Study (ATORVO)

Further study details as provided by University of Toronto:

Primary Outcome Measures:
  • 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:
  • 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 ]

Estimated Enrollment:   180
Study Start Date:   August 2007
Estimated Study Completion Date:   September 2009

Arms Assigned Interventions
A: Experimental
Atorvastatin 80 mg orally once daily for 24 weeks
Drug: Atorvastatin
80 mg orally once daily for 24 weeks
P: Placebo Comparator
Placebo tablet orally once daily for 24 weeks
Drug: Placebo
Placebo tablet orally once daily for 24 weeks

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.

  Eligibility
Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Criteria

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.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00517257

Contacts
Contact: Brigita Zile Zile, RN     416-864-6060 ext 4130     zileb@smh.toronto.on.ca    
Contact: Joel Ray, MD MSc     416-864-6060 ext 6752     rayj@smh.toronto.on.ca    

Locations
Canada, Ontario
St. Michael's Hospital     Recruiting
      Toronto, Ontario, Canada, M5B 1W8
      Contact: Brigita Zile, RN CCRP     416-864-6060 ext 4130     zileb@smh.toronto.on.ca    
      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
Pfizer
Canadian Heart Research Centre
Ontario Association of Optometrists
Toronto Ophthalmological Society

Investigators
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    
  More Information


Study ID Numbers:   NRA2580025
First Received:   August 14, 2007
Last Updated:   June 23, 2008
ClinicalTrials.gov Identifier:   NCT00517257
Health Authority:   Canada: Health Canada

Keywords provided by University of Toronto:
Retinal vein occlusion  
Retinal vein thrombosis  
Central retinal vein occlusion  
Branch retinal vein occlusion  
Visual loss  
Atorvastatin
Statin
Neovascularization
Thrombosis

Study placed in the following topic categories:
Embolism and Thrombosis
Embolism
Eye Diseases
Retinal Vein Occlusion
Vascular Diseases
Venous Thrombosis
Neovascularization, Pathologic
Atorvastatin
Retinal Diseases
Thrombosis
Vision, Low

Additional relevant MeSH terms:
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Antilipemic Agents
Enzyme Inhibitors
Cardiovascular Diseases
Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 07, 2008




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