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Atorvastatin for the Treatment of Retinal Vein Occlusion (ATORVO)

The recruitment status of this study is unknown because the information has not been verified recently.
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
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Atorvastatin Toronto Retinal Vein Occlusion Study (ATORVO)

Resource links provided by NLM:

U.S. FDA Resources

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
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

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

No publications provided

ClinicalTrials.gov Identifier: NCT00517257     History of Changes
Other Study ID Numbers: NRA2580025
Study First Received: August 14, 2007
Last Updated: June 23, 2008
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

Additional relevant MeSH terms:
Retinal Vein Occlusion
Thrombosis
Venous Thrombosis
Retinal Diseases
Eye Diseases
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Atorvastatin
 Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013