We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Evaluating How the Treatments in the Action to Control Cardiovascular Risk in Diabetes (ACCORD) Study Affect Diabetic Retinopathy (The ACCORD Eye Study)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00542178
Recruitment Status : Completed
First Posted : October 10, 2007
Results First Posted : November 26, 2013
Last Update Posted : July 24, 2018
Sponsor:
Collaborator:
National Eye Institute (NEI)
Information provided by (Responsible Party):
National Heart, Lung, and Blood Institute (NHLBI)

Tracking Information
First Submitted Date  ICMJE October 9, 2007
First Posted Date  ICMJE October 10, 2007
Results First Submitted Date  ICMJE April 27, 2012
Results First Posted Date  ICMJE November 26, 2013
Last Update Posted Date July 24, 2018
Study Start Date  ICMJE October 2003
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 27, 2018)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: October 9, 2007)
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 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 27, 2018)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: October 9, 2007)
Loss of visual acuity, cataract extraction, and development or progression of macular edema [ Time Frame: Measured at Year 4 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluating How the Treatments in the Action to Control Cardiovascular Risk in Diabetes (ACCORD) Study Affect Diabetic Retinopathy (The ACCORD Eye Study)
Official Title  ICMJE Action to Control Cardiovascular Risk in Diabetes (ACCORD) Eye Study
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE Diabetic Retinopathy
Intervention  ICMJE
  • Drug: Hypoglycemic Agents
    Multiple drugs including insulins and oral hypoglycemia agents for HbA1c less than 6%
  • Drug: Standard glycemia control
    A strategy of glycemia drugs for HbA1c 7% - 7.9%
  • Drug: Intensive BP treatment
    A strategy of multiple BP agents to reduce SBP less than 120 mm Hg
  • Drug: Standard BP control
    A strategy of BP drugs for SBP less than 140 mm Hg
  • Drug: Fenofibrate
    Blinded fenofibrate
  • Drug: Simvastatin
    Simvastatin 20-40 mg/d
  • Drug: Placebo
    Placebo
Study Arms  ICMJE
  • Experimental: Intensive glycemia control
    A strategy of intensive glycemia treatment to HbA1c less than 6%
    Intervention: Drug: Hypoglycemic Agents
  • Active Comparator: Standard glycemia control
    A strategy of multiple drugs to treat HbA1c to 7.0% - 7.9%
    Intervention: Drug: Standard glycemia control
  • Experimental: Intensive BP control
    A strategy of BP treatment for SBP less than 120 mm Hg
    Intervention: Drug: Intensive BP treatment
  • Active Comparator: Standard BP control
    A strategy of BP treatment for SBP less than 140 mm Hg
    Intervention: Drug: Standard BP control
  • Experimental: Fibrate
    Blinded fenofibrate + simvastatin 20-40 mg/d
    Interventions:
    • Drug: Fenofibrate
    • Drug: Simvastatin
  • Placebo Comparator: Fibrate Placebo
    Blinded placebo + simvastatin 20-40 mg/d
    Interventions:
    • Drug: Simvastatin
    • Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 22, 2013)
3472
Original Actual Enrollment  ICMJE
 (submitted: October 9, 2007)
4054
Actual Study Completion Date  ICMJE December 2009
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Participating in the ACCORD study

Exclusion Criteria:

  • Has had laser photocoagulation for DR
  • Has had vitrectomy surgery for DR
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 79 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00542178
Other Study ID Numbers  ICMJE 509
N01HC95178-19 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party National Heart, Lung, and Blood Institute (NHLBI)
Original Responsible Party Not Provided
Current Study Sponsor  ICMJE National Heart, Lung, and Blood Institute (NHLBI)
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE National Eye Institute (NEI)
Investigators  ICMJE
Principal Investigator: Walter T. Ambrosius, PhD Wake Forest University Health Sciences
Principal Investigator: Emily Y. Chew, MD National Eye Institute (NEI)
PRS Account National Heart, Lung, and Blood Institute (NHLBI)
Verification Date October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP