Completed

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

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What is being tested

Hypoglycemic Agents

+ Standard glycemia control

+ Intensive BP treatment

Drug
Who is being recruted

Cardiovascular Diseases+10

+ Diabetes Mellitus

+ Diabetes Mellitus, Type 2

From 40 to 79 Years
+3 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Prevention Study

Placebo-ControlledPhase 3
Interventional
Study Start: October 2003
See protocol details

Summary

Principal SponsorNational Heart, Lung, and Blood Institute (NHLBI)
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: October 1, 2003

Actual date on which the first participant was enrolled.

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 TitleAction to Control Cardiovascular Risk in Diabetes (ACCORD) Eye Study
NCT00542178
Principal SponsorNational Heart, Lung, and Blood Institute (NHLBI)
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

3472 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 40 to 79 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Cardiovascular DiseasesDiabetes MellitusDiabetes Mellitus, Type 2Diabetic AngiopathiesDiabetic RetinopathyEndocrine System DiseasesEye DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesRetinal DiseasesVascular DiseasesGlucose Metabolism DisordersDiabetes Complications

Criteria

1 inclusion criteria required to participate
Participating in the ACCORD study

2 exclusion criteria prevent from participating
Has had laser photocoagulation for DR

Has had vitrectomy surgery for DR

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

6 intervention groups are designated in this study

16.667% chance of being blinded to the placebo group

Treatment Groups

Group I

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

Group II

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

Group III

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

Group IV

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

Group 5

Experimental
Blinded fenofibrate + simvastatin 20-40 mg/d

Group 6

Placebo
Blinded placebo + simvastatin 20-40 mg/d

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 7 locations

Suspended

The Berman Center for Clinical Research

Minneapolis, United StatesOpen The Berman Center for Clinical Research in Google Maps
Suspended

Columbia University

New York, United States
Suspended

Wake Forest University Health Sciences

Winston-Salem, United States
Suspended

Case Western Reserve University

Cleveland, United States
Completed7 Study Centers