Atorvastatin for the Treatment of Retinal Vein Occlusion - Full Text View

Sponsor:	University of Toronto
Collaborators:	St. Michael's Hospital, Toronto Pfizer Canadian Heart Research Centre Ontario Association of Optometrists Toronto Ophthalmological Society
Information provided by:	University of Toronto
ClinicalTrials.gov Identifier:	NCT00517257

Purpose

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

Condition	Intervention	Phase
Retinal Vein Occlusion Retinal Vein Thrombosis Central Retinal Vein Occlusion Branch Retinal Vein Occlusion Thrombosis	Drug: Atorvastatin Drug: Placebo	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Atorvastatin Toronto Retinal Vein Occlusion Study (ATORVO)

Resource links provided by NLM:

MedlinePlus related topics: Deep Vein Thrombosis

Drug Information available for: Atorvastatin Atorvastatin calcium

U.S. FDA Resources

Further study details as provided by University of Toronto:

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. [ Time Frame: 24 weeks ]

Secondary Outcome Measures:

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

Estimated Enrollment:	180
Study Start Date:	August 2007
Estimated Study Completion Date:	September 2009

Arms	Assigned Interventions
A: Experimental Atorvastatin 80 mg orally once daily for 24 weeks	Drug: Atorvastatin 80 mg orally once daily for 24 weeks
P: Placebo Comparator Placebo tablet orally once daily for 24 weeks	Drug: Placebo Placebo tablet orally once daily for 24 weeks

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

Ages Eligible for Study:	40 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00517257

Contacts

Contact: Brigita Zile Zile, RN	416-864-6060 ext 4130	zileb@smh.toronto.on.ca
Contact: Joel Ray, MD MSc	416-864-6060 ext 6752	rayj@smh.toronto.on.ca

Locations

Canada, Ontario
St. Michael's Hospital	Recruiting
Toronto, Ontario, Canada, M5B 1W8
Contact: Brigita Zile, RN CCRP 416-864-6060 ext 4130 zileb@smh.toronto.on.ca
Principal Investigator: Joel G Ray, MD MSc
Principal Investigator: David T Wong, MD
Sub-Investigator: Larry Leiter, MD
Sub-Investigator: Shaun Goodman, MD MSc
Sub-Investigator: Anatoly Langer, MD

Sponsors and Collaborators

University of Toronto

St. Michael's Hospital, 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

More Information

No publications provided

Study ID Numbers:	NRA2580025
Study First Received:	August 14, 2007
Last Updated:	June 23, 2008
ClinicalTrials.gov Identifier:	NCT00517257 History of Changes
Health Authority:	Canada: Health Canada

Keywords provided by University of Toronto:

Retinal vein occlusion
Retinal vein thrombosis
Central retinal vein occlusion
Branch retinal vein occlusion
Visual loss

Atorvastatin
Statin
Neovascularization
Thrombosis

Additional relevant MeSH terms:

Antimetabolites
Molecular Mechanisms of Pharmacological Action
Eye Diseases
Antilipemic Agents
Vascular Diseases
Enzyme Inhibitors
Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions

Thrombosis
Embolism and Thrombosis
Therapeutic Uses
Retinal Vein Occlusion
Venous Thrombosis
Cardiovascular Diseases
Retinal Diseases
Atorvastatin

ClinicalTrials.gov processed this record on February 08, 2010