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

Diabetic Retinopathy Clinical Trial

Official title:

Action to Control Cardiovascular Risk in Diabetes (ACCORD) Eye Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00542178
• Other study ID #: 509
• Secondary ID: N01HC95178-19
• Status: Completed
• Phase: Phase 3
• Start date: October 2003
• Est. completion date: December 2009

Study information

• Verified date: October 2016
• Source: National Heart, Lung, and Blood Institute (NHLBI)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3472
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 79 Years

Eligibility

Inclusion Criteria:

• Participating in the ACCORD study

Exclusion Criteria:

• Has had laser photocoagulation for DR

• Has had vitrectomy surgery for DR

Related Conditions & MeSH terms

• Diabetic Retinopathy
• Retinal Diseases

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Canada	McMaster University	Hamilton	Ontario
United States	Case Western Reserve University	Cleveland	Ohio
United States	Veterans Affairs	Memphis	Tennessee
United States	The Berman Center for Clinical Research	Minneapolis	Minnesota
United States	Columbia University	New York	New York
United States	University of Washington	Seattle	Washington
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
National Heart, Lung, and Blood Institute (NHLBI)	National Eye Institute (NEI)

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (2)

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 — View Citation

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. Epub 2007 Apr 13. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Loss of Visual Acuity		Measured at Year 4
Secondary	Cataract Extraction		Measured at Year 4
Secondary	Development or Progression of Macular Edema		Measured at Year 4

External Links

•   Click here for the ACCORD Ancillary Studies Web site
•   Click here for the ACCORD Study Web site