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Sponsors and Collaborators: |
University of Toronto St. Michael's Hospital, Toronto Pfizer Canadian Heart Research Centre Ontario Association of Optometrists Toronto Ophthalmological Society |
Information provided by: | University of Toronto |
ClinicalTrials.gov Identifier: | NCT00517257 |
The ATORVO study is designed to determine whether atorvastatin (Lipitor) can improve vision, when compared to placebo
Condition | Intervention | Phase |
Retinal Vein Occlusion Retinal Vein Thrombosis Central Retinal Vein Occlusion Branch Retinal Vein Occlusion Thrombosis |
Drug: Atorvastatin Drug: Placebo |
Phase III |
ChemIDplus related topics: | Atorvastatin Atorvastatin calcium |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Atorvastatin Toronto Retinal Vein Occlusion Study (ATORVO) |
Estimated Enrollment: | 180 |
Study Start Date: | August 2007 |
Estimated Study Completion Date: | September 2009 |
Arms | Assigned Interventions |
A: Experimental
Atorvastatin 80 mg orally once daily for 24 weeks
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Drug: Atorvastatin
80 mg orally once daily for 24 weeks
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P: Placebo Comparator
Placebo tablet orally once daily for 24 weeks
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Drug: Placebo
Placebo tablet orally once daily for 24 weeks
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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.
Ages Eligible for Study: | 40 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Brigita Zile Zile, RN | 416-864-6060 ext 4130 | zileb@smh.toronto.on.ca |
Contact: Joel Ray, MD MSc | 416-864-6060 ext 6752 | rayj@smh.toronto.on.ca |
Canada, Ontario | |||||
St. Michael's Hospital | Recruiting | ||||
Toronto, Ontario, Canada, M5B 1W8 | |||||
Contact: Brigita Zile, RN CCRP 416-864-6060 ext 4130 zileb@smh.toronto.on.ca | |||||
Principal Investigator: Joel G Ray, MD MSc | |||||
Principal Investigator: David T Wong, MD | |||||
Sub-Investigator: Larry Leiter, MD | |||||
Sub-Investigator: Shaun Goodman, MD MSc | |||||
Sub-Investigator: Anatoly Langer, MD |
University of Toronto |
St. Michael's Hospital, Toronto |
Pfizer |
Canadian Heart Research Centre |
Ontario Association of Optometrists |
Toronto Ophthalmological Society |
Principal Investigator: | Joel G Ray, MD MSc | St. Michael's Hospital, University of Toronto |
Principal Investigator: | David Wong, MD | St. Michael's Hospital, University of Toronto |
Study ID Numbers: | NRA2580025 |
First Received: | August 14, 2007 |
Last Updated: | June 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00517257 |
Health Authority: | Canada: Health Canada |
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