ATORVO: Atorvastatin for the Treatment of Retinal Vein Occlusion

Sponsor

University of Toronto (Other)

Overall Status

Unknown status

CT.gov ID

NCT00517257

Collaborator

Unity Health Toronto (Other), Pfizer (Industry), Canadian Heart Research Centre (Other), Ontario Association of Optometrists (Other), Toronto Ophthalmological Society (Other)

180

Enrollment

Location

Arms

Duration (Months)

7.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Retinal Vein Occlusion Retinal Vein Thrombosis Central Retinal Vein Occlusion Branch Retinal Vein Occlusion Thrombosis	Drug: Atorvastatin Drug: Placebo	Phase 3

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

180 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Atorvastatin Toronto Retinal Vein Occlusion Study (ATORVO)

Study Start Date :

Aug 1, 2007

Anticipated Study Completion Date :

Sep 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: A Atorvastatin 80 mg orally once daily for 24 weeks	Drug: Atorvastatin 80 mg orally once daily for 24 weeks Other Names: Lipitor
Placebo Comparator: P Placebo tablet orally once daily for 24 weeks	Drug: Placebo Placebo tablet orally once daily for 24 weeks

Arm

Intervention/Treatment

Experimental: A

Atorvastatin 80 mg orally once daily for 24 weeks

Drug: Atorvastatin

80 mg orally once daily for 24 weeks

Other Names:

Lipitor

Placebo Comparator: P

Placebo tablet orally once daily for 24 weeks

Drug: Placebo

Placebo tablet orally once daily for 24 weeks

Outcome Measures

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. [24 weeks]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Locations

	Site	City	State	Country	Postal Code
1	St. Michael's Hospital	Toronto	Ontario	Canada	M5B 1W8

Sponsors and Collaborators

University of Toronto
Unity Health 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