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

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

Sponsors

Lead Sponsor: National Heart, Lung, and Blood Institute (NHLBI)

Collaborator: National Eye Institute (NEI)

Source National Heart, Lung, and Blood Institute (NHLBI)
Brief Summary

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.

Detailed 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.

Overall Status Completed
Start Date 2003-10-01
Completion Date 2009-12-01
Primary Completion Date 2009-12-01
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
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 Measured at Year 4
Secondary Outcome
Measure Time Frame
Loss of Visual Acuity Measured at Year 4
Cataract Extraction Measured at Year 4
Development or Progression of Macular Edema Measured at Year 4
Enrollment 3472
Condition
Intervention

Intervention Type: Drug

Intervention Name: Hypoglycemic Agents

Description: Multiple drugs including insulins and oral hypoglycemia agents for HbA1c less than 6%

Arm Group Label: Intensive glycemia control

Intervention Type: Drug

Intervention Name: Standard glycemia control

Description: A strategy of glycemia drugs for HbA1c 7% - 7.9%

Arm Group Label: Standard glycemia control

Intervention Type: Drug

Intervention Name: Intensive BP treatment

Description: A strategy of multiple BP agents to reduce SBP less than 120 mm Hg

Arm Group Label: Intensive BP control

Intervention Type: Drug

Intervention Name: Standard BP control

Description: A strategy of BP drugs for SBP less than 140 mm Hg

Arm Group Label: Standard BP control

Intervention Type: Drug

Intervention Name: Fenofibrate

Description: Blinded fenofibrate

Arm Group Label: Fibrate

Intervention Type: Drug

Intervention Name: Simvastatin

Description: Simvastatin 20-40 mg/d

Intervention Type: Drug

Intervention Name: Placebo

Description: Placebo

Arm Group Label: Fibrate Placebo

Eligibility

Criteria:

Inclusion Criteria: - Participating in the ACCORD study Exclusion Criteria: - Has had laser photocoagulation for DR - Has had vitrectomy surgery for DR

Gender:

All

Minimum Age:

40 Years

Maximum Age:

79 Years

Healthy Volunteers:

No

Overall Official
Location
Facility:
The Berman Center for Clinical Research | Minneapolis, Minnesota, 55404, United States
Columbia University | New York, New York, 10032, United States
Wake Forest University Health Sciences | Winston-Salem, North Carolina, 27157, United States
Case Western Reserve University | Cleveland, Ohio, 44106-4951, United States
Veterans Affairs | Memphis, Tennessee, 38104-2193, United States
University of Washington | Seattle, Washington, 98109, United States
McMaster University | Hamilton, Ontario, L8L 2X2, Canada
Location Countries

Canada

United States

Verification Date

2016-10-01

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 6
Arm Group

Label: Intensive glycemia control

Type: Experimental

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

Label: Standard glycemia control

Type: Active Comparator

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

Label: Intensive BP control

Type: Experimental

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

Label: Standard BP control

Type: Active Comparator

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

Label: Fibrate

Type: Experimental

Description: Blinded fenofibrate + simvastatin 20-40 mg/d

Label: Fibrate Placebo

Type: Placebo Comparator

Description: Blinded placebo + simvastatin 20-40 mg/d

Study Design Info

Allocation: Randomized

Intervention Model: Factorial Assignment

Primary Purpose: Prevention

Masking: Double (Participant, Investigator)

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