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| Tracking Information | |||||||||
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| First Received Date ICMJE | May 26, 2000 | ||||||||
| Last Updated Date | September 30, 2009 | ||||||||
| Start Date ICMJE | May 2000 | ||||||||
| Estimated Primary Completion Date | April 2005 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE | |||||||||
| Original Primary Outcome Measures ICMJE | |||||||||
| Change History | Complete list of historical versions of study NCT00005761 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | |||||||||
| Original Secondary Outcome Measures ICMJE | |||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Blood Factors and Diabetic Retinopathy | ||||||||
| Official Title ICMJE | Study of Association of Serum Factors With Diabetic Retinopathy | ||||||||
| Brief 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:
This study may lead to a better understanding of how diabetic retinopathy develops and progresses. |
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| 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. |
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| Study Phase | |||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | |||||||||
| Condition ICMJE | Diabetic Retinopathy | ||||||||
| Intervention ICMJE | |||||||||
| Study Arms / Comparison Groups | |||||||||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Enrollment ICMJE | 225 | ||||||||
| Completion Date | |||||||||
| Estimated Primary Completion Date | April 2005 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
Subjects will be able to enroll if they:
EXCLUSION CRITERIA: Subjects will not be eligible if they:
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| Gender | Both | ||||||||
| Ages | 10 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00005761 | ||||||||
| Responsible Party | |||||||||
| Study ID Numbers ICMJE | 000135, 00-EI-0135 | ||||||||
| Study Sponsor ICMJE | National Eye Institute (NEI) | ||||||||
| Collaborators ICMJE | |||||||||
| Investigators ICMJE | |||||||||
| Information Provided By | National Institutes of Health Clinical Center (CC) | ||||||||
| Verification Date | September 2009 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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