Status:
TERMINATED
Evaluation of Single Nucleotide Polymorphisms (SNPs) in Patients With and Without Diabetic Macular Edema
Lead Sponsor:
National Eye Institute (NEI)
Conditions:
Diabetic Retinopathy
Diabetic Macular Edema
Eligibility:
All Genders
18+ years
Brief Summary
Background: \- Diabetic macular edema (DME) is a common condition in people with diabetes. DME occurs when blood vessels in the eye leak fluid, resulting in swelling inside the back of the eye and pr...
Detailed Description
Objective: The objective of this study is to test the hypothesis that genetic polymorphisms of vascular endothelial growth factor (VEGF), erythropoietin (EPO), endothelin-1 (EDN1) and receptor for ad...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- All participants must meet the following criteria:
- Participant is diagnosed with type 2 diabetes prior to enrollment.
- Participant must understand and sign this protocol s informed consent document and agree to provide a blood sample for analysis.
- Participant must be 18 years of age or older.\<TAB\>
- DME Participants (cases):
- Participant is diagnosed with active DME defined by fluorescein leakage associated with either central retinal thickness greater than 260 microns on spectral domain OCT or cystic changes present on OCT.
- OR
- Participant has evidence of focal laser scars indicative of prior DME Investigators will verify the laser therapy was performed for DME via medical records, fluorescein angiograms or photographs.
- Non-DME Participants (controls)
- Participant has no evidence of DME defined fluorescein leakage associated with either central retinal thickness greater than 260 microns on spectral domain OCT or cystic changes present on OCT.
- Participant has no evidence of focal laser scars indicative of prior DME.
- EXCLUSION CRITERIA:
- Participant has another retinal disease that may confound the evaluation of the DME. Examples include vein occlusions, uveitic macular edema or neovascular age-related macular degeneration.
- Participant has opacities of the ocular media, limitations of pupillary dilation or other problems sufficient to preclude adequate dilated examination.
Exclusion
Key Trial Info
Start Date :
July 7 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 7 2013
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT01168258
Start Date
July 7 2010
End Date
August 7 2013
Last Update
October 6 2017
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892