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临床试验/NCT00542178
NCT00542178已完成3 期

Action to Control Cardiovascular Risk in Diabetes (ACCORD) Eye Study

National Heart, Lung, and Blood Institute (NHLBI)7 个研究点 分布在 2 个国家目标入组 3,472 人开始时间: 2003年10月最近更新:
适应症
干预措施
相关药物

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

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

Active Comparator

A strategy of multiple drugs to treat HbA1c to 7.0% - 7.9%

干预措施: Standard glycemia control (Drug)

Intensive glycemia control

Experimental

A strategy of intensive glycemia treatment to HbA1c less than 6%

干预措施: Hypoglycemic Agents (Drug)

Intensive BP control

Experimental

A strategy of BP treatment for SBP less than 120 mm Hg

干预措施: Intensive BP treatment (Drug)

Standard BP control

Active Comparator

A strategy of BP treatment for SBP less than 140 mm Hg

干预措施: Standard BP control (Drug)

Fibrate

Experimental

Blinded fenofibrate + simvastatin 20-40 mg/d

干预措施: Fenofibrate (Drug)

Fibrate

Experimental

Blinded fenofibrate + simvastatin 20-40 mg/d

干预措施: Simvastatin (Drug)

Fibrate Placebo

Placebo Comparator

Blinded placebo + simvastatin 20-40 mg/d

干预措施: Simvastatin (Drug)

Fibrate Placebo

Placebo Comparator

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)

研究者

申办方类型
Nih
责任方
Sponsor

研究点 (7)

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