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

NCT00542178 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 3472

Last updated 2018-07-24

Study results available
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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.

Conditions

Interventions

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

Sponsors & Collaborators

  • National Eye Institute (NEI)

    collaborator NIH

  • National Heart, Lung, and Blood Institute (NHLBI)

    lead NIH

Principal Investigators

  • Walter T. Ambrosius, PhD · Wake Forest University Health Sciences

  • Emily Y. Chew, MD · National Eye Institute (NEI)

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
FACTORIAL

Eligibility

Min Age
40 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-10-31
Primary Completion
2009-12-31
Completion
2009-12-31

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00542178 on ClinicalTrials.gov