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| Name | Class |
|---|---|
| Unity Health Toronto | OTHER |
| Pfizer | INDUSTRY |
| Canadian Heart Research Centre | OTHER |
| Ontario Association of Optometrists |
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The ATORVO study is designed to determine whether atorvastatin (Lipitor) can improve vision, when compared to placebo
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | Atorvastatin 80 mg orally once daily for 24 weeks |
|
| P | Placebo Comparator | Placebo tablet orally once daily for 24 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atorvastatin | Drug | 80 mg orally once daily for 24 weeks |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Brigita Zile Zile, RN | Contact | 416-864-6060 | 4130 | zileb@smh.toronto.on.ca |
| Joel Ray, MD MSc | Contact | 416-864-6060 | 6752 | rayj@smh.toronto.on.ca |
| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Michael's Hospital | Recruiting | Toronto | Ontario | M5B 1W8 | Canada |
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| ID | Term |
|---|---|
| D012170 | Retinal Vein Occlusion |
| D013927 | Thrombosis |
| D014786 | Vision Disorders |
| D009389 | Neovascularization, Pathologic |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D020246 | Venous Thrombosis |
| D016769 | Embolism and Thrombosis |
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| ID | Term |
|---|---|
| D000069059 | Atorvastatin |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| OTHER |
| Toronto Ophthalmological Society | UNKNOWN |
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| Placebo | Drug | Placebo tablet orally once daily for 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 |
| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008679 | Metaplasia |
| D010335 | Pathologic Processes |
| D006538 |
| Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |