NCT00517257

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
180

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Aug 2007

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2007

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

August 14, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 16, 2007

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

June 25, 2008

Status Verified

June 1, 2008

First QC Date

August 14, 2007

Last Update Submit

June 23, 2008

Conditions

Retinal Vein OcclusionRetinal Vein ThrombosisCentral Retinal Vein OcclusionBranch Retinal Vein OcclusionThrombosis

Keywords

Retinal vein occlusionRetinal vein thrombosisCentral retinal vein occlusionBranch retinal vein occlusionVisual lossAtorvastatinStatinNeovascularizationThrombosis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • 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

Study Arms (2)

A

EXPERIMENTAL

Atorvastatin 80 mg orally once daily for 24 weeks

Drug: Atorvastatin

P

PLACEBO COMPARATOR

Placebo tablet orally once daily for 24 weeks

Drug: Placebo

Interventions

AtorvastatinDRUG

80 mg orally once daily for 24 weeks

Also known as: Lipitor
A
PlaceboDRUG

Placebo tablet orally once daily for 24 weeks

P

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

RECRUITING

MeSH Terms

Conditions

Retinal Vein OcclusionThrombosisVision DisordersNeovascularization, Pathologic

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesVenous ThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsMetaplasiaPathologic Processes

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipids

Study Officials

  • Joel G Ray, MD MSc

    St. Michael's Hospital, University of Toronto

    PRINCIPAL INVESTIGATOR

  • David Wong, MD

    St. Michael's Hospital, University of Toronto

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Brigita Zile Zile, RN

CONTACT

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

Joel Ray, MD MSc

CONTACT

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

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 14, 2007

First Posted

August 16, 2007

Study Start

August 1, 2007

Study Completion

September 1, 2009

Last Updated

June 25, 2008

Record last verified: 2008-06

Locations

CA(1)