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

Last updated: June 27, 2018
Sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Overall Status: Completed

Phase

3

Condition

Retina

Diabetic Retinopathy

Treatment

N/A

Clinical Study ID

NCT00542178
509
N01HC95178-19
  • Ages 40-79
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participating in the ACCORD study

Exclusion

Exclusion Criteria:

  • Has had laser photocoagulation for DR

  • Has had vitrectomy surgery for DR

Study Design

Total Participants: 3472
Study Start date:
October 01, 2003
Estimated Completion Date:
December 31, 2009

Study 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.

Connect with a study center

  • McMaster University

    Hamilton, Ontario L8L 2X2
    Canada

    Site Not Available

  • The Berman Center for Clinical Research

    Minneapolis, Minnesota 55404
    United States

    Site Not Available

  • Columbia University

    New York, New York 10032
    United States

    Site Not Available

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina 27157
    United States

    Site Not Available

  • Case Western Reserve University

    Cleveland, Ohio 44106-4951
    United States

    Site Not Available

  • Veterans Affairs

    Memphis, Tennessee 38104-2193
    United States

    Site Not Available

  • University of Washington

    Seattle, Washington 98109
    United States

    Site Not Available

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