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

Phase 3

Completed

• Conditions: Diabetic Retinopathy
• Interventions: Drug: Intensive BP treatment; Drug: Standard BP control; Drug: Fenofibrate; Drug: Hypoglycemic Agents; Drug: Standard glycemia control; Drug: Simvastatin; Drug: Placebo

• Registration Number: NCT00542178
• Lead Sponsor: 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.

Study Timeline

• Study Start: 2003-10
• Study First Submitted: 2007-10-09
• Study First Submitted QC: 2007-10-09
• Study First Posted: 2007-10-10
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Results First Submitted: 2012-04-27
• Results First Submitted QC: 2013-11-22
• Results First Posted: 2013-11-26
• Status Verified: 2016-10
• Last Update Submitted: 2018-06-27
• Last Update Posted: 2018-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3472

Inclusion Criteria

• Participating in the ACCORD study

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Intensive BP control	Intensive BP treatment	A strategy of BP treatment for SBP less than 120 mm Hg
Standard BP control	Standard BP control	A strategy of BP treatment for SBP less than 140 mm Hg
Fibrate	Fenofibrate	Blinded fenofibrate + simvastatin 20-40 mg/d
Fibrate	Simvastatin	Blinded fenofibrate + simvastatin 20-40 mg/d
Fibrate Placebo	Placebo	Blinded placebo + simvastatin 20-40 mg/d
Intensive glycemia control	Hypoglycemic Agents	A strategy of intensive glycemia treatment to HbA1c less than 6%
Standard glycemia control	Standard glycemia control	A strategy of multiple drugs to treat HbA1c to 7.0% - 7.9%
Fibrate Placebo	Simvastatin	Blinded placebo + simvastatin 20-40 mg/d

Primary Outcome Measures

Name	Time	Method
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	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.

Secondary Outcome Measures

Name	Time	Method
Loss of Visual Acuity	Measured at Year 4
Cataract Extraction	Measured at Year 4
Development or Progression of Macular Edema	Measured at Year 4

Trial Locations

Locations (7)

Veterans Affairs; 🇺🇸 Memphis, Tennessee, United States

Columbia University; 🇺🇸 New York, New York, United States

The Berman Center for Clinical Research; 🇺🇸 Minneapolis, Minnesota, United States

Wake Forest University Health Sciences; 🇺🇸 Winston-Salem, North Carolina, United States

University of Washington; 🇺🇸 Seattle, Washington, United States

McMaster University; 🇨🇦 Hamilton, Ontario, Canada

Case Western Reserve University; 🇺🇸 Cleveland, Ohio, United States