Evaluating How the Treatments in the Action to Control Cardiovascular Risk in Diabetes (ACCORD) Study Affect Diabetic Retinopathy (The ACCORD Eye Study)
NCT ID: NCT00542178
Last Updated: 2018-07-24
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
3472 participants
INTERVENTIONAL
2003-10-31
2009-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
PREVENTION
DOUBLE
Study Groups
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Intensive glycemia control
A strategy of intensive glycemia treatment to HbA1c less than 6%
Hypoglycemic Agents
Multiple drugs including insulins and oral hypoglycemia agents for HbA1c less than 6%
Standard glycemia control
A strategy of multiple drugs to treat HbA1c to 7.0% - 7.9%
Standard glycemia control
A strategy of glycemia drugs for HbA1c 7% - 7.9%
Intensive BP control
A strategy of BP treatment for SBP less than 120 mm Hg
Intensive BP treatment
A strategy of multiple BP agents to reduce SBP less than 120 mm Hg
Standard BP control
A strategy of BP treatment for SBP less than 140 mm Hg
Standard BP control
A strategy of BP drugs for SBP less than 140 mm Hg
Fibrate
Blinded fenofibrate + simvastatin 20-40 mg/d
Fenofibrate
Blinded fenofibrate
Simvastatin
Simvastatin 20-40 mg/d
Fibrate Placebo
Blinded placebo + simvastatin 20-40 mg/d
Simvastatin
Simvastatin 20-40 mg/d
Placebo
Placebo
Interventions
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Hypoglycemic Agents
Multiple drugs including insulins and oral hypoglycemia agents for HbA1c less than 6%
Standard glycemia control
A strategy of glycemia drugs for HbA1c 7% - 7.9%
Intensive BP treatment
A strategy of multiple BP agents to reduce SBP less than 120 mm Hg
Standard BP control
A strategy of BP drugs for SBP less than 140 mm Hg
Fenofibrate
Blinded fenofibrate
Simvastatin
Simvastatin 20-40 mg/d
Placebo
Placebo
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Has had vitrectomy surgery for DR
40 Years
79 Years
ALL
No
Sponsors
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National Eye Institute (NEI)
NIH
National Heart, Lung, and Blood Institute (NHLBI)
NIH
Responsible Party
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Principal Investigators
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Walter T. Ambrosius, PhD
Role: PRINCIPAL_INVESTIGATOR
Wake Forest University Health Sciences
Emily Y. Chew, MD
Role: PRINCIPAL_INVESTIGATOR
National Eye Institute (NEI)
Locations
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The Berman Center for Clinical Research
Minneapolis, Minnesota, United States
Columbia University
New York, New York, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
Case Western Reserve University
Cleveland, Ohio, United States
Veterans Affairs
Memphis, Tennessee, United States
University of Washington
Seattle, Washington, United States
McMaster University
Hamilton, Ontario, Canada
Countries
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References
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Chew EY, Ambrosius WT, Howard LT, Greven CM, Johnson S, Danis RP, Davis MD, Genuth S, Domanski M; ACCORD Study Group. Rationale, design, and methods of the Action to Control Cardiovascular Risk in Diabetes Eye Study (ACCORD-EYE). Am J Cardiol. 2007 Jun 18;99(12A):103i-111i. doi: 10.1016/j.amjcard.2007.03.028. Epub 2007 Apr 13.
ACCORD Study Group; ACCORD Eye Study Group; Chew EY, Ambrosius WT, Davis MD, Danis RP, Gangaputra S, Greven CM, Hubbard L, Esser BA, Lovato JF, Perdue LH, Goff DC Jr, Cushman WC, Ginsberg HN, Elam MB, Genuth S, Gerstein HC, Schubart U, Fine LJ. Effects of medical therapies on retinopathy progression in type 2 diabetes. N Engl J Med. 2010 Jul 15;363(3):233-44. doi: 10.1056/NEJMoa1001288. Epub 2010 Jun 29.
Do DV, Han G, Abariga SA, Sleilati G, Vedula SS, Hawkins BS. Blood pressure control for diabetic retinopathy. Cochrane Database Syst Rev. 2023 Mar 28;3(3):CD006127. doi: 10.1002/14651858.CD006127.pub3.
Action to Control Cardiovascular Risk in Diabetes Follow-On (ACCORDION) Eye Study Group and the Action to Control Cardiovascular Risk in Diabetes Follow-On (ACCORDION) Study Group. Persistent Effects of Intensive Glycemic Control on Retinopathy in Type 2 Diabetes in the Action to Control Cardiovascular Risk in Diabetes (ACCORD) Follow-On Study. Diabetes Care. 2016 Jul;39(7):1089-100. doi: 10.2337/dc16-0024. Epub 2016 Jun 11.
Chew EY, Davis MD, Danis RP, Lovato JF, Perdue LH, Greven C, Genuth S, Goff DC, Leiter LA, Ismail-Beigi F, Ambrosius WT; Action to Control Cardiovascular Risk in Diabetes Eye Study Research Group. The effects of medical management on the progression of diabetic retinopathy in persons with type 2 diabetes: the Action to Control Cardiovascular Risk in Diabetes (ACCORD) Eye Study. Ophthalmology. 2014 Dec;121(12):2443-51. doi: 10.1016/j.ophtha.2014.07.019. Epub 2014 Aug 29.
Wong TY, Simo R, Mitchell P. Fenofibrate - a potential systemic treatment for diabetic retinopathy? Am J Ophthalmol. 2012 Jul;154(1):6-12. doi: 10.1016/j.ajo.2012.03.013.
Ambrosius WT, Danis RP, Goff DC Jr, Greven CM, Gerstein HC, Cohen RM, Riddle MC, Miller ME, Buse JB, Bonds DE, Peterson KA, Rosenberg YD, Perdue LH, Esser BA, Seaquist LA, Felicetta JV, Chew EY; ACCORD Study Group. Lack of association between thiazolidinediones and macular edema in type 2 diabetes: the ACCORD eye substudy. Arch Ophthalmol. 2010 Mar;128(3):312-8. doi: 10.1001/archophthalmol.2009.310.
Related Links
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Click here for the ACCORD Study Web site
Other Identifiers
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N01 HC095178-19
Identifier Type: -
Identifier Source: secondary_id
509
Identifier Type: -
Identifier Source: org_study_id
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