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Blood Factors and Diabetic Retinopathy
This study is currently recruiting participants.
Verified by National Institutes of Health Clinical Center (CC), September 2008
First Received: May 26, 2000   Last Updated: October 6, 2008   History of Changes
Sponsored by: National Eye Institute (NEI)
Information provided by: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00005761
  Purpose

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

MedlinePlus related topics: Adhesions Diabetes Diabetic Eye Problems Retinal Disorders
U.S. FDA Resources
Study Type: Observational
Official Title: Study of Association of Serum Factors With Diabetic Retinopathy

Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 225
Study Start Date: May 2000
Detailed Description:

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

Ages Eligible for Study:   10 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005761

Contacts
Contact: Patient Recruitment and Public Liaison Office (800) 411-1222 prpl@mail.cc.nih.gov
Contact: TTY 1-866-411-1010

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
  More Information

Additional Information:
Publications:
Study ID Numbers: 000135, 00-EI-0135
Study First Received: May 26, 2000
Last Updated: October 6, 2008
ClinicalTrials.gov Identifier: NCT00005761     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Types 1 & 2 Diabetes
Cell Adhesion Molecules
Chemokines
Vascular Endothelial Growth Factor
Cross-sectional
Serum Levels
Diabetic Retinopathy

Study placed in the following topic categories:
Diabetic Retinopathy
Eye Diseases
Vascular Diseases
Diabetes Mellitus
Mitogens
Endocrine System Diseases
Adhesions
Endocrinopathy
Endothelial Growth Factors
Diabetes Complications
Retinal Diseases
Diabetic Angiopathies

Additional relevant MeSH terms:
Diabetic Retinopathy
Eye Diseases
Diabetes Mellitus
Vascular Diseases
Endocrine System Diseases
Cardiovascular Diseases
Diabetes Complications
Retinal Diseases
Diabetic Angiopathies

ClinicalTrials.gov processed this record on May 07, 2009