Blood Factors and Diabetic Retinopathy

Sponsor

National Eye Institute (NEI) (NIH)

Overall Status

Completed

CT.gov ID

NCT00005761

Collaborator

(none)

173

Enrollment

Location

126.5

Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study will determine whether certain factors in the blood are associated with the severity of diabetic retinopathy.

Patients age 10 years and older with diabetes mellitus and diabetic retinopathy may be eligible for this study. Those enrolled will represent a range of diabetic retinopathy from minimal to severe. Participants will undergo the following procedures:

medical history
thorough eye examination
photographs of the eye
blood tests to measure blood lipids (cholesterol and triglycerides) and serum creatinine (for kidney function)
blood tests to measure levels of blood factors (cell adhesion molecules, chemokines and vascular endothelial growth factor) that may be related to the progression of diabetic retinopathy
blood pressure measurement
urinalysis

This study may lead to a better understanding of how diabetic retinopathy develops and progresses.

Condition or Disease	Intervention/Treatment	Phase
Diabetic Retinopathy

Detailed Description

Participants with a range of severity of diabetic retinopathy and healthy volunteers will be evaluated once for serum levels of cell adhesion molecules, chemokines and vascular endothelial growth factor. This study may lead to a better understanding of the pathogenesis of diabetic retinopathy and the identifying of possible targets for treatment. All study participants will undergo an ocular exam and ophthalmic photography. Blood is drawn for the analysis of these serum factors.

Study Design

Study Type:

Observational

Actual Enrollment :

173 participants

Official Title:

Study of Association of Serum Factors With Diabetic Retinopathy

Study Start Date :

May 23, 2000

Study Completion Date :

Dec 7, 2010

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

10 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

VOLUNTEER INCLUSION CRITERIA:

Volunteers will be able to enroll if they:

Have the ability to understand and sign an informed consent.
Are able and willing to give a blood sample.
Are healthy as determined by study Investigator.
Have no chronic diseases.
Do not exhibit any clinical indications of diabetes.

PARTICIPANT INCLUSION CRITERIA:

Participants will be able to enroll if they:

Have the ability to understand and sign an informed consent.
Are able and willing to give a blood sample.
Have a clinical diagnosis of diabetes based on any one of the following criteria:

Documented history of plasma glucose value greater than or equal to 210 mg/dl on three different occasions.
Fasting blood sugar greater than or equal to 150 mg/dl on three different occasions.
Documented history of ketoacidosis.
Insulin dependency.
Documented history of abnormal glucose tolerance test.

EXCLUSION CRITERIA:

Neither volunteers nor participants will be eligible if they:

Are under the age of 10.
Have severe systemic disease(s) that compromise our ability to obtain an adequate examination.
Have any of the following ocular characteristics or conditions in both eyes:

Opacities of the ocular media, limitations or pupillary dilation or any other problems sufficient to preclude good, quality stereo fundus photographs.
Ocular disease which confounds assessment of diabetic retinopathy such as advanced age-related macular degeneration, central serous choroidopathy, optic atrophy, retinal vein occlusion, active uveitis, significant explained or unexplained visual field loss, or any other type of retinopathy or retinal degeneration.
Chronic requirement for any ocular medication for other diseases, such as glaucoma.