Atorvastatin Toronto Retinal Vein Occlusion Study (ATORVO)
试验速览
- 阶段
- 3 期
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
The ATORVO study is designed to determine whether atorvastatin (Lipitor) can improve vision, when compared to placebo
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
A
Atorvastatin 80 mg orally once daily for 24 weeks
干预措施: Atorvastatin (Drug)
P
Placebo tablet orally once daily for 24 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
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.
时间窗: 24 weeks
次要结局
- Mean change in the concentration of serum total cholesterol, LDL-cholesterol and highly sensitive C-reactive protein at 0 and 24 weeks.(24 weeks)
- 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)