Action to Control Cardiovascular Risk in Diabetes (ACCORD) Eye Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 3,472
- 试验地点
- 7
- 主要终点
- Number of Participants With Progression of Diabetic Retinopathy of at Least 3 Stages on the Early Treatment Diabetic Retinopathy Study (ETDRS) Scale, or Development of Proliferative Diabetic Retinopathy Necessitating Photocoagulation Therapy or Vitrectomy
研究概览
简要总结
Diabetic retinopathy (DR) is an eye disease that can occur in people with diabetes and can cause poor vision or blindness. The Action to Control Cardiovascular Risk in Diabetes (ACCORD) study is examining the effect of various treatments on cardiovascular disease in people with diabetes. This current study will examine the effects of the ACCORD treatments on the progression of DR in people participating in the ACCORD study.
详细描述
DR is the most common diabetic eye disease and is the leading cause of blindness in adults in the United States. It is caused by damage to the blood vessels of the retina, which is the light-sensitive outer layer of the eye. Retinal blood vessels are often affected by the high blood sugar levels associated with diabetes. Older people have an increased risk of developing DR; however, DR is likely to occur earlier and be more severe in anyone who has poorly controlled diabetes. Almost everyone who has had diabetes for more than 30 years will eventually show signs of DR. Symptoms of DR include poor night vision, seeing spots in front of the eyes, blurred vision, and blindness. The ACCORD study is a study that is examining the effects of different treatments on cardiovascular disease in people with diabetes. Participants in the ACCORD study will receive one of eight different combinations of treatment, including blood sugar control, blood pressure control, and cholesterol-controlling medication. This study will enroll participants in the ACCORD study and will examine the effects of the study treatments on DR. The results from this study may be used to develop new treatments to help prevent diabetes-related blindness.
Study visits will occur at baseline and Year 4. At each study visit, participants will have an eye exam and specialized fundus photographs taken of the back of the eye and retina.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 79 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participating in the ACCORD study
排除标准
- •Has had laser photocoagulation for DR
- •Has had vitrectomy surgery for DR
研究组 & 干预措施
Standard glycemia control
A strategy of multiple drugs to treat HbA1c to 7.0% - 7.9%
干预措施: Standard glycemia control (Drug)
Intensive glycemia control
A strategy of intensive glycemia treatment to HbA1c less than 6%
干预措施: Hypoglycemic Agents (Drug)
Intensive BP control
A strategy of BP treatment for SBP less than 120 mm Hg
干预措施: Intensive BP treatment (Drug)
Standard BP control
A strategy of BP treatment for SBP less than 140 mm Hg
干预措施: Standard BP control (Drug)
Fibrate
Blinded fenofibrate + simvastatin 20-40 mg/d
干预措施: Fenofibrate (Drug)
Fibrate
Blinded fenofibrate + simvastatin 20-40 mg/d
干预措施: Simvastatin (Drug)
Fibrate Placebo
Blinded placebo + simvastatin 20-40 mg/d
干预措施: Simvastatin (Drug)
Fibrate Placebo
Blinded placebo + simvastatin 20-40 mg/d
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants With Progression of Diabetic Retinopathy of at Least 3 Stages on the Early Treatment Diabetic Retinopathy Study (ETDRS) Scale, or Development of Proliferative Diabetic Retinopathy Necessitating Photocoagulation Therapy or Vitrectomy
时间窗: Measured at Year 4
Diabetic retinopathy status was defined according to the eye with the highest level on the ETDRS Final Severity Scale for Persons, as follows: no diabetic retinopathy, a level of less than 20; mild diabetic retinopathy, a level of 20; moderate nonproliferative diabetic retinopathy (NPDR), a level above 20 but less than 53; severe diabetic retinopathy, a level of 53 but less than 60; and proliferative diabetic retinopathy (PDR), a level of 60 or higher.
次要结局
- Loss of Visual Acuity(Measured at Year 4)
- Cataract Extraction(Measured at Year 4)
- Development or Progression of Macular Edema(Measured at Year 4)
