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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00542178
First received: October 9, 2007
Last updated: November 22, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention Phase
Diabetic Retinopathy
Drug: Hypoglycemic Agents
Drug: Standard glycemia control
Drug: Intensive BP treatment
Drug: Standard BP control
Drug: Fenofibrate
Drug: Simvastatin
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Action to Control Cardiovascular Risk in Diabetes (ACCORD) Eye Study

Resource links provided by NLM:


Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Loss of Visual Acuity, Cataract Extraction, or Development or Progression of Macular Edema [ Time Frame: Measured at Year 4 ] [ Designated as safety issue: No ]

Enrollment: 3472
Study Start Date: October 2003
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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: Simvastatin
Simvastatin 20-40 mg/d
Drug: Placebo
Placebo

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.

  Eligibility

Ages Eligible for Study:   40 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participating in the ACCORD study

Exclusion Criteria:

  • Has had laser photocoagulation for DR
  • Has had vitrectomy surgery for DR
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00542178

Locations
United States, Minnesota
The Berman Center for Clinical Research
Minneapolis, Minnesota, United States, 55404
United States, New York
Columbia University
New York, New York, United States, 10032
United States, North Carolina
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
Case Western Reserve University
Cleveland, Ohio, United States, 44106-4951
United States, Tennessee
Veterans Affairs
Memphis, Tennessee, United States, 38104-2193
United States, Washington
University of Washington
Seattle, Washington, United States, 98109
Canada, Ontario
McMaster University
Hamilton, Ontario, Canada, L8L 2X2
Sponsors and Collaborators
Investigators
Principal Investigator: Walter T. Ambrosius, PhD Wake Forest School of Medicine
Principal Investigator: Emily Y. Chew, MD National Eye Institute (NEI)
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier: NCT00542178     History of Changes
Other Study ID Numbers: 509, N01 HC095178-19
Study First Received: October 9, 2007
Results First Received: April 27, 2012
Last Updated: November 22, 2013
Health Authority: United States: Federal Government

Keywords provided by National Heart, Lung, and Blood Institute (NHLBI):
Type 2 Diabetes Mellitus
Cardiovascular Diseases

Additional relevant MeSH terms:
Diabetic Retinopathy
Retinal Diseases
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Hypoglycemic Agents
Fenofibrate
Simvastatin
Physiological Effects of Drugs
Pharmacologic Actions
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Enzyme Inhibitors

ClinicalTrials.gov processed this record on July 20, 2014