Clinical trial NCT00517257: Atorvastatin for the Treatment of Retinal Vein Occlusion
Official title: Atorvastatin Toronto Retinal Vein Occlusion Study (ATORVO)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Retinal Vein Occlusion
Retinal Vein Thrombosis
Central Retinal Vein Occlusion
Branch Retinal Vein Occlusion
Thrombosis
Keywords: Retinal vein occlusion
Retinal vein thrombosis
Central retinal vein occlusion
Branch retinal vein occlusion
Visual loss
Atorvastatin
Statin
Neovascularization
Thrombosis
Lead sponsor: University of Toronto
Sponsor class: OTHER
Collaborators: name: Unity Health Toronto
name: Pfizer
name: Canadian Heart Research Centre
name: Ontario Association of Optometrists
name: Toronto Ophthalmological Society
First posted: 2007-08-16
Enrollment: 180
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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 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.

Primary outcomes:
measure: 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.
timeFrame: 24 weeks
Secondary outcomes:
measure: Prevention of ocular neovascularization or need for laser treatment by 24 weeks.
timeFrame: 24 weeks
measure: Reduction in macular edema, measured by optical coherence tomography at 24 weeks.
timeFrame: 24 weeks
measure: Mean change in The National Eye Institute 25-Item Visual Function Questionnaire-25 (VFQ-25) score from 0 to 24 weeks.
timeFrame: 24 weeks
measure: Composite of non-fatal myocardial infarction, hospitalization for acute coronary syndrome, receipt of coronary revascularization, stroke or death, by 52 weeks.
timeFrame: 24 weeks
measure: Mean change in the concentration of serum total cholesterol, LDL-cholesterol and highly sensitive C-reactive protein at 0 and 24 weeks.
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
Study officials:
affiliation: St. Michael's Hospital, University of Toronto
name: Joel G Ray, MD MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Michael's Hospital, University of Toronto
name: David Wong, MD
role: PRINCIPAL_INVESTIGATOR
References: