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Blood Factors and Diabetic Retinopathy



Blood Factors and Diabetic Retinopathy

For Condition: Diabetic Retinopathy
Status: Recruiting
Sponsor(s): National Eye Institute (NEI) ,
Synopsis: 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.
Details: 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.
Eligibility:
Study Type:
  Observational, Natural History
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry 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.
Total Enrollment: 175

Location and Contact Information:

National Eye Institute (NEI) *Recruiting*
Bethesda,  Maryland,  20892
United States
Recruiting Patient  and Public Liaison Office 1-800-411-1222


Additional Information:
Study ID Numbers:
  000135;  00-EI-0135
Study Start Date: May 23, 2000
Record last reviewed: June 2, 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005761

Other Diabetic Retinopathy Studies:
1. Screening for Studies on Retinovascular Diseases

2. Diabetic Retinopathy Study (DRS)

3. Blood Factors and Diabetic Retinopathy

4. Diabetic Retinopathy Vitrectomy Study (DRVS)

5. Pilot Study of Laser Photocoagulation Therapy for Diabetic Macular Edema

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Blood Factors and Diabetic Retinopathy

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