Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Evaluating How the Treatments in the Action to Control Cardiovascular Risk in Diabetes (ACCORD) Study Affect Diabetic Retinopathy (The ACCORD Eye Study)
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
National Eye Institute (NEI)
Information provided by: National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier: NCT00542178
  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: Blood Sugar Control
Drug: Blood Lipids Control
Drug: Blood Pressure Control
Phase III

MedlinePlus related topics: Diabetes Diabetic Eye Problems Retinal Disorders
Drug Information available for: Lipids
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized, Double Blind (Subject, Investigator), Factorial Assignment, Efficacy Study
Official Title: Action to Control Cardiovascular Risk in Diabetes (ACCORD) Eye Study

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

Primary Outcome Measures:
  • Progression of DR of at least 3 stages on the Early Treatment Diabetic Retinopathy Study (ETDRS) scale, photocoagulation, and vitrectomy [ Time Frame: Measured at Year 4 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Loss of visual acuity, cataract extraction, and development or progression of macular edema [ Time Frame: Measured at Year 4 ] [ Designated as safety issue: No ]

Enrollment: 4054
Study Start Date: October 2003
Estimated Study Completion Date: June 2009
Estimated Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Active Comparator
Intensive Blood Sugar Control and Active Fibrate Drug
Drug: Blood Sugar Control
Intensive or Standard Glycemia as described in the ACCORD trial
Drug: Blood Lipids Control
Placebo vs. Active Lipid Lowering Drugs as described in the ACCORD trial
2: Active Comparator
Intensive Blood Sugar Control and Placebo Fibrate Drug
Drug: Blood Sugar Control
Intensive or Standard Glycemia as described in the ACCORD trial
Drug: Blood Lipids Control
Placebo vs. Active Lipid Lowering Drugs as described in the ACCORD trial
3: Active Comparator
Intensive Blood Sugar Control and Intensive Blood Pressure Control
Drug: Blood Sugar Control
Intensive or Standard Glycemia as described in the ACCORD trial
Drug: Blood Pressure Control
Intensive or Standard Blood Pressure levels as described in the ACCORD trial
4: Active Comparator
Intensive Blood Sugar Control and Standard Blood Pressure Control
Drug: Blood Sugar Control
Intensive or Standard Glycemia as described in the ACCORD trial
Drug: Blood Pressure Control
Intensive or Standard Blood Pressure levels as described in the ACCORD trial
5: Active Comparator
Standard Blood Sugar Control and Active Fibrate Drug
Drug: Blood Sugar Control
Intensive or Standard Glycemia as described in the ACCORD trial
Drug: Blood Lipids Control
Placebo vs. Active Lipid Lowering Drugs as described in the ACCORD trial
6: Active Comparator
Standard Blood Sugar Control and Placebo Fibrate Drug
Drug: Blood Sugar Control
Intensive or Standard Glycemia as described in the ACCORD trial
Drug: Blood Lipids Control
Placebo vs. Active Lipid Lowering Drugs as described in the ACCORD trial
7: Active Comparator
Standard Blood Sugar Control and Intensive Blood Pressure Control
Drug: Blood Sugar Control
Intensive or Standard Glycemia as described in the ACCORD trial
Drug: Blood Pressure Control
Intensive or Standard Blood Pressure levels as described in the ACCORD trial
8: Active Comparator
Standard Blood Sugar Control and Standard Blood Pressure Control
Drug: Blood Sugar Control
Intensive or Standard Glycemia as described in the ACCORD trial
Drug: Blood Pressure Control
Intensive or Standard Blood Pressure levels as described in the ACCORD trial

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
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 University
Principal Investigator: Emily Y. Chew, MD National Eye Institute (NEI)
  More Information

Click here for the ACCORD Ancillary Studies Web site  This link exits the ClinicalTrials.gov site
Click here for the ACCORD Study Web site  This link exits the ClinicalTrials.gov site

Publications:
Responsible Party: National Heart, Lung, and Blood Institute (NHLBI) ( Denise Simons-Morton, MD, PhD )
Study ID Numbers: 509, N01 HC095178-19
Study First Received: October 9, 2007
Last Updated: July 29, 2008
ClinicalTrials.gov Identifier: NCT00542178  
Health Authority: United States: Federal Government

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

Study placed in the following topic categories:
Diabetic Retinopathy
Eye Diseases
Diabetes Mellitus, Type 2
Vascular Diseases
Diabetes Mellitus
Endocrine System Diseases
Endocrinopathy
Diabetes Complications
Retinal Diseases
Diabetic Angiopathies

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 15, 2009