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

June 27, 2018 updated by: National Heart, Lung, and Blood Institute (NHLBI)

Action to Control Cardiovascular Risk in Diabetes (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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

3472

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8L 2X2
        • McMaster University
  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55404
        • The Berman Center for Clinical Research
    • New York
      • New York, New York, United States, 10032
        • Columbia University
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest University Health Sciences
    • Ohio
      • Cleveland, Ohio, United States, 44106-4951
        • Case Western Reserve University
    • Tennessee
      • Memphis, Tennessee, United States, 38104-2193
        • Veterans Affairs
    • Washington
      • Seattle, Washington, United States, 98109
        • University of Washington

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Participating in the ACCORD study

Exclusion Criteria:

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

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Double

Arms and Interventions

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

What is the study measuring?

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
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.
Measured at Year 4

Secondary Outcome Measures

Outcome Measure
Time Frame
Loss of Visual Acuity
Time Frame: Measured at Year 4
Measured at Year 4
Cataract Extraction
Time Frame: Measured at Year 4
Measured at Year 4
Development or Progression of Macular Edema
Time Frame: Measured at Year 4
Measured at Year 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Collaborators

National Eye Institute (NEI)

Investigators

  • Principal Investigator: Emily Y. Chew, MD, National Eye Institute (NEI)
  • Principal Investigator: Walter T. Ambrosius, PhD, Wake Forest University Health Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2003

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

October 9, 2007

First Submitted That Met QC Criteria

October 9, 2007

First Posted (Estimate)

October 10, 2007

Study Record Updates

Last Update Posted (Actual)

July 24, 2018

Last Update Submitted That Met QC Criteria

June 27, 2018

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 509 (Guttmatcher Institute)
  • N01HC95178-19 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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