Evaluating How the Treatments in the Action to Control Cardiovascular Risk in Diabetes (ACCORD) Study Affect Diabetic Retinopathy (The ACCORD Eye Study)
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| ClinicalTrials.gov Identifier: NCT00542178 |
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Recruitment Status :
Completed
First Posted : October 10, 2007
Results First Posted : November 26, 2013
Last Update Posted : July 24, 2018
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| Condition or disease | Intervention/treatment | 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 |
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 (Clinical Trial) |
| Actual Enrollment : | 3472 participants |
| Allocation: | Randomized |
| Intervention Model: | Factorial Assignment |
| Masking: | Double (Participant, Investigator) |
| Primary Purpose: | Prevention |
| Official Title: | Action to Control Cardiovascular Risk in Diabetes (ACCORD) Eye Study |
| Study Start Date : | October 2003 |
| Actual Primary Completion Date : | December 2009 |
| Actual Study Completion Date : | December 2009 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Intensive glycemia control
A strategy of intensive glycemia treatment to HbA1c less than 6%
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Drug: Hypoglycemic Agents
Multiple drugs including insulins and oral hypoglycemia agents for HbA1c less than 6% |
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Active Comparator: Standard glycemia control
A strategy of multiple drugs to treat HbA1c to 7.0% - 7.9%
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Drug: Standard glycemia control
A strategy of glycemia drugs for HbA1c 7% - 7.9% |
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Experimental: Intensive BP control
A strategy of BP treatment for SBP less than 120 mm Hg
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Drug: Intensive BP treatment
A strategy of multiple BP agents to reduce SBP less than 120 mm Hg |
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Active Comparator: Standard BP control
A strategy of BP treatment for SBP less than 140 mm Hg
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Drug: Standard BP control
A strategy of BP drugs for SBP less than 140 mm Hg |
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Experimental: Fibrate
Blinded fenofibrate + simvastatin 20-40 mg/d
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Drug: Fenofibrate
Blinded fenofibrate Drug: Simvastatin Simvastatin 20-40 mg/d |
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Placebo Comparator: Fibrate Placebo
Blinded placebo + simvastatin 20-40 mg/d
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Drug: Simvastatin
Simvastatin 20-40 mg/d Drug: Placebo Placebo |
- 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.
- Loss of Visual Acuity [ Time Frame: Measured at Year 4 ]
- Cataract Extraction [ Time Frame: Measured at Year 4 ]
- Development or Progression of Macular Edema [ Time Frame: Measured at Year 4 ]
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| Ages Eligible for Study: | 40 Years to 79 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Participating in the ACCORD study
Exclusion Criteria:
- Has had laser photocoagulation for DR
- Has had vitrectomy surgery for DR
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00542178
| 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 Health Sciences | |
| Principal Investigator: | Emily Y. Chew, MD | National Eye Institute (NEI) |
Publications of Results:
Other Publications:
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 |
| Other Study ID Numbers: |
509 N01HC95178-19 ( U.S. NIH Grant/Contract ) |
| First Posted: | October 10, 2007 Key Record Dates |
| Results First Posted: | November 26, 2013 |
| Last Update Posted: | July 24, 2018 |
| Last Verified: | October 2016 |
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Type 2 Diabetes Mellitus Cardiovascular Diseases |
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Retinal Diseases Diabetic Retinopathy Eye Diseases Diabetic Angiopathies Vascular Diseases Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Endocrine System Diseases Hypoglycemic Agents |
Simvastatin Fenofibrate Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Enzyme Inhibitors Physiological Effects of Drugs |