Atorvastatin for the Treatment of Retinal Vein Occlusion

• Status: Unknown status
• Trial end date: 2009-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Toronto
• Collaborators: Canadian Heart Research Centre; Ontario Association of Optometrists; Pfizer; St. Michael's Hospital, Toronto; Toronto Ophthalmological Society; Unity Health Toronto
• Treatments: Atorvastatin; Atorvastatin Calcium

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.