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
Diabetic Retinopathy

50 patients with a range of severity of diabetic retinopathy 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.

Patients will undergo an ocular exam and ophthalmic photography. Blood is drawn for the analysis of these serum factors.

Genders Eligible for Study:  Both

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.

Maryland
      National Eye Institute (NEI), 9000 Rockville Pike,  Bethesda,  Maryland,  20892,  United States; Recruiting

Study ID Numbers:  000135; 00-EI-0135
Record last reviewed:  June 14, 2004
Last Updated:  June 14, 2004
Record first received:  May 26, 2000
ClinicalTrials.gov Identifier:  NCT00005761
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2004-11-04