Atorvastatin for the Treatment of Retinal Vein Occlusion

NCT00517257

Last updated date
Study Location
St. Michael's Hospital
Toronto, Ontario, M5B 1W8, Canada
Contact
416-864-6060

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Retinal Vein Occlusion, Retinal Vein Thrombosis, Central Retinal Vein Occlusion, Branch Retinal Vein Occlusion, Thrombosis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
40 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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Retinal Vein Occlusion, Retinal Vein Thrombosis, Central Retinal Vein Occlusion, Branch Retinal Vein Occlusion, ThrombosisAtorvastatin for the Treatment of Retinal Vein Occlusion
NCT00517257
  1. Toronto, Ontario
ALL GENDERS
40 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Atorvastatin for the Treatment of Retinal Vein Occlusion
Official Title  ICMJE Atorvastatin Toronto Retinal Vein Occlusion Study (ATORVO)
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Retinal Vein Occlusion
  • Retinal Vein Thrombosis
  • Central Retinal Vein Occlusion
  • Branch Retinal Vein Occlusion
  • Thrombosis
Intervention  ICMJE
  • Drug: Atorvastatin
    80 mg orally once daily for 24 weeks
    Other Name: Lipitor
  • Drug: Placebo
    Placebo tablet orally once daily for 24 weeks
Study Arms  ICMJE
  • Experimental: A
    Atorvastatin 80 mg orally once daily for 24 weeks
    Intervention: Drug: Atorvastatin
  • Placebo Comparator: P
    Placebo tablet orally once daily for 24 weeks
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: August 14, 2007)
180
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2009
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00517257
Other Study ID Numbers  ICMJE NRA2580025
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE University of Toronto
Collaborators  ICMJE
  • St. Michael's Hospital, Toronto
  • Pfizer
  • Canadian Heart Research Centre
  • Ontario Association of Optometrists
  • Toronto Ophthalmological Society
Investigators  ICMJE
Principal Investigator:Joel G Ray, MD MScSt. Michael's Hospital, University of Toronto
Principal Investigator:David Wong, MDSt. Michael's Hospital, University of Toronto
PRS Account University of Toronto
Verification Date June 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP