Evaluating How the Treatments in the Action to Control Cardiovascular Risk in Diabetes (ACCORD) Study Affect Diabetic Retinopathy (The ACCORD Eye Study)
Action to Control Cardiovascular Risk in Diabetes (ACCORD) Eye Study
3 other identifiers
interventional
3,472
2 countries
7
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Oct 2003
Longer than P75 for phase_3
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2003
CompletedFirst Submitted
Initial submission to the registry
October 9, 2007
CompletedFirst Posted
Study publicly available on registry
October 10, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedResults Posted
Study results publicly available
November 26, 2013
CompletedJuly 24, 2018
October 1, 2016
6.2 years
October 9, 2007
April 27, 2012
June 27, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
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.
Measured at Year 4
Secondary Outcomes (3)
Loss of Visual Acuity
Measured at Year 4
Cataract Extraction
Measured at Year 4
Development or Progression of Macular Edema
Measured at Year 4
Study Arms (6)
Intensive glycemia control
EXPERIMENTALA strategy of intensive glycemia treatment to HbA1c less than 6%
Standard glycemia control
ACTIVE COMPARATORA strategy of multiple drugs to treat HbA1c to 7.0% - 7.9%
Intensive BP control
EXPERIMENTALA strategy of BP treatment for SBP less than 120 mm Hg
Standard BP control
ACTIVE COMPARATORA strategy of BP treatment for SBP less than 140 mm Hg
Fibrate
EXPERIMENTALBlinded fenofibrate + simvastatin 20-40 mg/d
Fibrate Placebo
PLACEBO COMPARATORBlinded placebo + simvastatin 20-40 mg/d
Interventions
Multiple drugs including insulins and oral hypoglycemia agents for HbA1c less than 6%
A strategy of glycemia drugs for HbA1c 7% - 7.9%
A strategy of multiple BP agents to reduce SBP less than 120 mm Hg
Eligibility Criteria
You may qualify if:
- Participating in the ACCORD study
You may not qualify if:
- Has had laser photocoagulation for DR
- Has had vitrectomy surgery for DR
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
The Berman Center for Clinical Research
Minneapolis, Minnesota, 55404, United States
Columbia University
New York, New York, 10032, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157, United States
Case Western Reserve University
Cleveland, Ohio, 44106-4951, United States
Veterans Affairs
Memphis, Tennessee, 38104-2193, United States
University of Washington
Seattle, Washington, 98109, United States
McMaster University
Hamilton, Ontario, L8L 2X2, Canada
Related Publications (7)
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.
PMID: 17599420BACKGROUNDACCORD 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.
PMID: 20587587RESULTDo 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.
PMID: 36975019DERIVEDAction 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.
PMID: 27289122DERIVEDChew 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.
PMID: 25172198DERIVEDWong 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.
PMID: 22709833DERIVEDAmbrosius 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.
PMID: 20212201DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
The glycemia trial was stopped early, potentially underestimating the reported effect of glycemia treatment on diabetic retinopathy.
Results Point of Contact
- Title
- Dr. Walter Ambrosius, PhD
- Organization
- Wake Forest University School of Medicine
Study Officials
- PRINCIPAL INVESTIGATOR
Walter T. Ambrosius, PhD
Wake Forest University Health Sciences
- PRINCIPAL INVESTIGATOR
Emily Y. Chew, MD
National Eye Institute (NEI)
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- FACTORIAL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 9, 2007
First Posted
October 10, 2007
Study Start
October 1, 2003
Primary Completion
December 1, 2009
Study Completion
December 1, 2009
Last Updated
July 24, 2018
Results First Posted
November 26, 2013
Record last verified: 2016-10