Atorvastatin for the Treatment of Retinal Vein Occlusion

Thrombosis Clinical Trial

— ATORVO  

Official title:

Atorvastatin Toronto Retinal Vein Occlusion Study (ATORVO)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00517257
• Other study ID #: NRA2580025
• Status: Recruiting
• Phase: Phase 3
• First received: August 14, 2007
• Last updated: June 23, 2008
• Start date: August 2007
• Est. completion date: September 2009

Study information

• Verified date: June 2008
• Source: University of Toronto
• Contact: Brigita Zile Zile, RN
• Phone: 416-864-6060
• Email: zileb[@]smh.toronto.on.ca
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: September 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Branch Retinal Vein Occlusion
• Central Retinal Vein Occlusion
• Retinal Vein Occlusion
• Retinal Vein Thrombosis
• Thrombosis
• Venous Thrombosis

Intervention

Drug:
• Atorvastatin
80 mg orally once daily for 24 weeks
• Placebo
Placebo tablet orally once daily for 24 weeks

Locations

Country	Name	City	State
Canada	St. Michael's Hospital	Toronto	Ontario

Sponsors (6)

Lead Sponsor	Collaborator
University of Toronto	Canadian Heart Research Centre, Ontario Association of Optometrists, Pfizer, St. Michael's Hospital, Toronto, Toronto Ophthalmological Society

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		24 weeks
Secondary	Prevention of ocular neovascularization or need for laser treatment by 24 weeks.		24 weeks
Secondary	Reduction in macular edema, measured by optical coherence tomography at 24 weeks.		24 weeks
Secondary	Mean change in The National Eye Institute 25-Item Visual Function Questionnaire-25 (VFQ-25) score from 0 to 24 weeks.		24 weeks
Secondary	Composite of non-fatal myocardial infarction, hospitalization for acute coronary syndrome, receipt of coronary revascularization, stroke or death, by 52 weeks.		24 weeks
Secondary	Mean change in the concentration of serum total cholesterol, LDL-cholesterol and highly sensitive C-reactive protein at 0 and 24 weeks.		24 weeks