Action to Control Cardiovascular Risk in Diabetes (ACCORD) Eye Study
Hypoglycemic Agents
+ Standard glycemia control
+ Intensive BP treatment
Cardiovascular Diseases+10
+ Diabetes Mellitus
+ Diabetes Mellitus, Type 2
Prevention Study
Summary
Study start date: October 1, 2003
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.3472 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Prevention Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 40 to 79 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.6 intervention groups are designated in this study
16.667% chance of being blinded to the placebo group
Treatment Groups
Group I
ExperimentalGroup II
Active ComparatorGroup III
ExperimentalGroup IV
Active ComparatorGroup 5
ExperimentalGroup 6
PlaceboStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 7 locations
The Berman Center for Clinical Research
Minneapolis, United StatesOpen The Berman Center for Clinical Research in Google MapsColumbia University
New York, United StatesWake Forest University Health Sciences
Winston-Salem, United StatesCase Western Reserve University
Cleveland, United States