Evaluating How the Treatments in the Action to Control Cardiovascular Risk in Diabetes (ACCORD) Study Affect Diabetic Retinopathy (The ACCORD Eye Study)

National Institutes of Health (NIH)

Status and phase: Completed; Phase 3

Conditions: Diabetic Retinopathy

Treatments: Drug: Standard BP control; Drug: Intensive BP treatment; Drug: Hypoglycemic Agents; Drug: Simvastatin; Drug: Standard glycemia control; Drug: Placebo; Drug: Fenofibrate

Study type: Interventional

Funder types: NIH

Identifiers

NCT00542178

N01HC95178-19 (U.S. NIH Grant/Contract)

509

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 3,472 patients

Sex: All

Ages: 40 to 79 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participating in the ACCORD study

Exclusion criteria

• Has had laser photocoagulation for DR
• Has had vitrectomy surgery for DR

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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3,472 participants in 6 patient groups, including a placebo group

Intensive glycemia control

Experimental group

Description:

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

Treatment:

Drug: Hypoglycemic Agents

Standard glycemia control

Active Comparator group

Description:

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

Treatment:

Drug: Standard glycemia control

Intensive BP control

Experimental group

Description:

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

Treatment:

Drug: Intensive BP treatment

Standard BP control

Active Comparator group

Description:

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

Treatment:

Drug: Standard BP control

Fibrate

Experimental group

Description:

Blinded fenofibrate + simvastatin 20-40 mg/d

Treatment:

Drug: Fenofibrate

Drug: Simvastatin

Fibrate Placebo

Placebo Comparator group

Description:

Blinded placebo + simvastatin 20-40 mg/d

Treatment:

Drug: Placebo

Drug: Simvastatin