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Completed

NCT Number: NCT00542178

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

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.

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Key information

Age range

40 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

McMaster University, Hamilton, Ontario, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participating in the ACCORD study

Exclusion criteria

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

Treatment and study plan

Hypoglycemic Agents

Drug

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

Standard glycemia control

Drug

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

Intensive BP treatment

Drug

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

Standard BP control

Drug

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

fenofibrate

Drug

Blinded fenofibrate

simvastatin

Drug

Simvastatin 20-40 mg/d

Placebo

Drug

Placebo

Primary outcomes

  1. 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

    Time frame: 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 outcomes

  1. Loss of Visual Acuity

    Time frame: Measured at Year 4

  2. Cataract Extraction

    Time frame: Measured at Year 4

  3. Development or Progression of Macular Edema

    Time frame: Measured at Year 4

Sponsors and collaborators

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Nih

Collaborators

  • National Eye Institute (NEI)

Registry information

Official study title

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

Important dates

Study start
2003
Primary completion
2009
Study completion
2009
First posted
Oct 10, 2007
Registry last updated
Jul 24, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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