Home
Search
Study Topics
Glossary
|
|
|
|
|
|
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 |
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 |
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 |
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
|
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.
Ages Eligible for Study: | 40 Years to 79 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
Principal Investigator: | Walter T. Ambrosius, PhD | Wake Forest University |
Principal Investigator: | Emily Y. Chew, MD | National Eye Institute (NEI) |
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 |
Type 2 Diabetes Mellitus Cardiovascular Diseases |
Diabetic Retinopathy Eye Diseases Diabetes Mellitus, Type 2 Vascular Diseases Diabetes Mellitus |
Endocrine System Diseases Endocrinopathy Diabetes Complications Retinal Diseases Diabetic Angiopathies |
Cardiovascular Diseases |