Protocol Number: 00-EI-0135

Title:

Study of Association of Serum Factors with Diabetic Retinopathy

Number:

00-EI-0135

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.

Sponsoring Institute:

National Eye Institute (NEI)

Recruitment Detail

Type: Active Accrual Of New Subjects

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): None

Eligibility Criteria:

INCLUSION CRITERIA:

1. Patients with a diagnosis of diabetes mellitus (types 1 and 2) and presence of diabetic retinopathy will be entered into this study.

2. Patients may have mild nonproliferative diabetic retinopathy to proliferative retinopathy (previously treated or untreated), with or without clinically significant macular edema.

3. Participants will be be age 10 or older.

General Medical:

Clinical diagnosis of diabetes based on any one of the following criteria:

1. Documented history of plasma glucose value greater than or equal to 210 mg/dl on 3 different occasions;

2. Fasting blood sugar greater than or equal to 150 mg/dl on 3 different occasions;

3. Documented history of ketoacidosis;

4. Insulin dependency;

5. Documented history of abnormal glucose tolerance test.

EXCLUSION CRITERIA:

General Ocular:

A. Opacities of the ocular media, limitations of pupillary dilation or any other problems sufficient to preclude good quality stereo fundus photographs;

B. 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.

C. Chronic requirement for any ocular medication for other diseases such as glaucoma.

Special Instructions: Currently Not Provided

Keywords:

Types 1 & 2 Diabetes

Cell Adhesion Molecules

Chemokines

Vascular Endothelial Growth Factor

Cross-sectional

Serum Levels

Recruitment Keywords:

Diabetic Retinopathy

Conditions:

Diabetic Retinopathy

Investigational Drug(s):

None

Investigational Device(s):

None

Contacts:

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citations:

Platelet abnormalities in diabetes mellitus

Enhanced prothrombin and intrinsic factor X activation on blood platelets from diabetic patients

Cell biology of endothelial cells

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
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