Atorvastatin for the Treatment of Retinal Vein Occlusion (ATORVO)

University of Toronto

Status and phase

Unknown

Phase 3

Conditions

Retinal Vein Thrombosis

Thrombosis

Central Retinal Vein Occlusion

Retinal Vein Occlusion

Branch Retinal Vein Occlusion

Treatments

Drug: Placebo

Drug: Atorvastatin

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00517257

NRA2580025

Details and patient eligibility

About

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

Full 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.

Enrollment

180 estimated patients

Sex

All

Ages

40+ years old

Volunteers

Accepts Healthy Volunteers

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.