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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Diabetic Retinopathy

Intervention / Treatment
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* Drug: Hypoglycemic Agents
* Drug: Standard glycemia control
* Drug: Intensive BP treatment
* Drug: Standard BP control
* Drug: Fenofibrate
* Drug: Simvastatin
* Drug: Placebo


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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intensive glycemia control<br>A strategy of intensive glycemia treatment to HbA1c less than 6% | Drug: Hypoglycemic Agents<br>* Multiple drugs including insulins and oral hypoglycemia agents for HbA1c less than 6%<br>|
| Active Comparator: Standard glycemia control<br>A strategy of multiple drugs to treat HbA1c to 7.0% - 7.9% | Drug: Standard glycemia control<br>* A strategy of glycemia drugs for HbA1c 7% - 7.9%<br>|
| Experimental: Intensive BP control<br>A strategy of BP treatment for SBP less than 120 mm Hg | Drug: Intensive BP treatment<br>* A strategy of multiple BP agents to reduce SBP less than 120 mm Hg<br>|
| Active Comparator: Standard BP control<br>A strategy of BP treatment for SBP less than 140 mm Hg | Drug: Standard BP control<br>* A strategy of BP drugs for SBP less than 140 mm Hg<br>|
| Experimental: Fibrate<br>Blinded fenofibrate + simvastatin 20-40 mg/d | Drug: Fenofibrate<br>* Blinded fenofibrate<br>Drug: Simvastatin<br>* Simvastatin 20-40 mg/d<br>|
| Placebo Comparator: Fibrate Placebo<br>Blinded placebo + simvastatin 20-40 mg/d | Drug: Simvastatin<br>* Simvastatin 20-40 mg/d<br>Drug: Placebo<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | 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. | Measured at Year 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 2 Diabetes Mellitus, Cardiovascular Diseases