Recruiting
Phase 3

Atorvastatin

Sponsor:

University of Toronto

Code:

NCT00517257

Conditions

Retinal Vein Occlusion

Retinal Vein Thrombosis

Central Retinal Vein Occlusion

Branch Retinal Vein Occlusion

Thrombosis

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Accepted

Interventions

Atorvastatin

Placebo

Study Details

Brief summary:

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

Conditions

Retinal Vein Occlusion

Retinal Vein Thrombosis

Central Retinal Vein Occlusion

Branch Retinal Vein Occlusion

Thrombosis

Study ID

NCT00517257

Start date

Aug, 2007

Status verified date

Jun, 2008

Completion date

Sep, 2009

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

180 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: A

Atorvastatin 80 mg orally once daily for 24 weeks

placebo comparator: P

Placebo tablet orally once daily for 24 weeks

Interventions

Atorvastatin

80 mg orally once daily for 24 weeks

Placebo

Placebo tablet orally once daily for 24 weeks

Primary outcome 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. [ Time Frame: 24 weeks ]

Central Contacts and Locations

Central contacts

Brigita Zile Zile, RN

416-864-6060zileb@smh.toronto.on.ca

Joel Ray, MD MSc

416-864-6060rayj@smh.toronto.on.ca

Locations

St. Michael's Hospital

Recruiting

Toronto, Ontario, Canada, M5B 1W8

Contacts

Brigita Zile, RN CCRP

416-864-6060zileb@smh.toronto.on.ca

Principal Investigator:

Joel G Ray, MD MSc

More Information

Sponsor

University of Toronto

Last update posted

Jun 25, 2008

Last verified

Jun, 2008

Keywords

  • Retinal vein occlusion
  • Retinal vein thrombosis
  • Central retinal vein occlusion
  • Branch retinal vein occlusion
  • Visual loss
  • Atorvastatin
  • Statin
  • Neovascularization
  • Thrombosis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Toronto on 2008-06-25.