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Blood Factors and Diabetic Retinopathy
This study is currently recruiting participants.
Study NCT00005761   Information provided by National Institutes of Health Clinical Center (CC)
First Received: May 26, 2000   Last Updated: September 30, 2009   History of Changes

May 26, 2000
September 30, 2009
May 2000
April 2005   (final data collection date for primary outcome measure)
 
 
Complete list of historical versions of study NCT00005761 on ClinicalTrials.gov Archive Site
 
 
 
Blood Factors and Diabetic Retinopathy
Study of Association of Serum Factors With Diabetic Retinopathy

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.

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.

 
Observational
 
Diabetic Retinopathy
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
225
 
April 2005   (final data collection date for primary outcome measure)
  • INCLUSION CRITERIA:

Subjects will be able to enroll if they:

  1. Have the ability to understand and sign an informed consent.
  2. Are able and willing to give a blood sample.
  3. 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:

Subjects will not be eligible if they:

  1. Are under the age of 10.
  2. Have impaired decision making capabilities without an authorized designated representative.
  3. Have severe systemic disease(s) that compromise our ability to obtain an adequate examination.
  4. 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.
Both
10 Years and older
No
Contact: Patient Recruitment and Public Liaison Office (800) 411-1222 prpl@mail.cc.nih.gov
Contact: TTY 1-866-411-1010
United States
 
NCT00005761
 
000135, 00-EI-0135
National Eye Institute (NEI)
 
 
National Institutes of Health Clinical Center (CC)
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP