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Atorvastatin for the Treatment of Retinal Vein Occlusion (ATORVO)

Primary Purpose

Retinal Vein Occlusion, Retinal Vein Thrombosis, Central Retinal Vein Occlusion

Status
Unknown status
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Atorvastatin
Placebo
Sponsored by
University of Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Retinal Vein Occlusion focused on measuring Retinal vein occlusion, Retinal vein thrombosis, Central retinal vein occlusion, Branch retinal vein occlusion, Visual loss, Atorvastatin, Statin, Neovascularization, Thrombosis

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • St. Michael's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

A

P

Arm Description

Atorvastatin 80 mg orally once daily for 24 weeks

Placebo tablet orally once daily for 24 weeks

Outcomes

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.

Secondary Outcome Measures

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

Full Information

First Posted
August 14, 2007
Last Updated
June 23, 2008
Sponsor
University of Toronto
Collaborators
Unity Health Toronto, Pfizer, Canadian Heart Research Centre, Ontario Association of Optometrists, Toronto Ophthalmological Society
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1. Study Identification

Unique Protocol Identification Number
NCT00517257
Brief Title
Atorvastatin for the Treatment of Retinal Vein Occlusion
Acronym
ATORVO
Official Title
Atorvastatin Toronto Retinal Vein Occlusion Study (ATORVO)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2008
Overall Recruitment Status
Unknown status
Study Start Date
August 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
University of Toronto
Collaborators
Unity Health Toronto, Pfizer, Canadian Heart Research Centre, Ontario Association of Optometrists, Toronto Ophthalmological Society

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
Atorvastatin 80 mg orally once daily for 24 weeks
Arm Title
P
Arm Type
Placebo Comparator
Arm Description
Placebo tablet orally once daily for 24 weeks
Intervention Type
Drug
Intervention Name(s)
Atorvastatin
Other Intervention Name(s)
Lipitor
Intervention Description
80 mg orally once daily for 24 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo tablet orally once daily for 24 weeks
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Prevention of ocular neovascularization or need for laser treatment by 24 weeks.
Time Frame
24 weeks
Title
Reduction in macular edema, measured by optical coherence tomography at 24 weeks.
Time Frame
24 weeks
Title
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
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Brigita Zile Zile, RN
Phone
416-864-6060
Ext
4130
Email
zileb@smh.toronto.on.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Joel Ray, MD MSc
Phone
416-864-6060
Ext
6752
Email
rayj@smh.toronto.on.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joel G Ray, MD MSc
Organizational Affiliation
St. Michael's Hospital, University of Toronto
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David Wong, MD
Organizational Affiliation
St. Michael's Hospital, University of Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Michael's Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1W8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brigita Zile, RN CCRP
Phone
416-864-6060
Ext
4130
Email
zileb@smh.toronto.on.ca
First Name & Middle Initial & Last Name & Degree
Joel G Ray, MD MSc
First Name & Middle Initial & Last Name & Degree
David T Wong, MD
First Name & Middle Initial & Last Name & Degree
Larry Leiter, MD
First Name & Middle Initial & Last Name & Degree
Shaun Goodman, MD MSc
First Name & Middle Initial & Last Name & Degree
Anatoly Langer, MD

12. IPD Sharing Statement

Learn more about this trial

Atorvastatin for the Treatment of Retinal Vein Occlusion

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