Evaluation of Single Nucleotide Polymorphisms (SNPs) in Patients With and Without Diabetic Macular Edema

NCT01168258 | Terminated

• 2 other identifiers: 10016910-EI-0169
• Study Type: observational
• Target: 68
• Locations: 1 country
• Sites: 1

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 progressive vision loss. Research has shown that good blood sugar control can reduce the risk and severity of DME. However, not all diabetic patients with poor blood sugar control develop DME, and some patients develop DME despite excellent blood sugar control. This suggests that other factors, such as genes or inherited traits, may predispose or protect a diabetic patient from developing DME. Objectives: \- To investigate genetic factors that may influence the development of diabetic macular edema. Eligibility: \- Individuals at least 18 years of age who have type 2 diabetes, with or without diabetic macular edema. Design:

• The study will require one visit to the National Institutes of Health eye clinic.
• Participants will be screened with a medical history and basic eye examination. Individuals who have certain eye diseases other than DME may not be allowed to enroll in the study.
• Participants will provide a blood sample, and will receive fluorescein angiography (an injection of fluorescein dye, after which a camera will take pictures of the dye as it flows through the blood vessels in the eye).
• No treatment will be provided as part of this protocol.

Conditions

Diabetic Retinopathy; Diabetic Macular Edema

Keywords

Diabetic Retinopathy; Diabetes; Single Nucleotide Polymorphism (SNP); Diabetic Macular Edema

Outcome Measures

Primary Outcomes (1)

• Genotype frequency of SNP in the study genes of DME participants and control participants.

Secondary Outcomes (1)

• Secondary outcomes are ophthalmic measurements, including visual acuity, FA and OCT data, to investigate associations between detected genetic polymorphisms and response to conventional diabetic retinopathy treatment.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Eye Institute (NEI): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Wild S, Roglic G, Green A, Sicree R, King H. Global prevalence of diabetes: estimates for the year 2000 and projections for 2030. Diabetes Care. 2004 May;27(5):1047-53. doi: 10.2337/diacare.27.5.1047.

  PMID: 15111519 BACKGROUND

• Risch NJ. Searching for genetic determinants in the new millennium. Nature. 2000 Jun 15;405(6788):847-56. doi: 10.1038/35015718.

  PMID: 10866211 BACKGROUND

• Martin ER, Lai EH, Gilbert JR, Rogala AR, Afshari AJ, Riley J, Finch KL, Stevens JF, Livak KJ, Slotterbeck BD, Slifer SH, Warren LL, Conneally PM, Schmechel DE, Purvis I, Pericak-Vance MA, Roses AD, Vance JM. SNPing away at complex diseases: analysis of single-nucleotide polymorphisms around APOE in Alzheimer disease. Am J Hum Genet. 2000 Aug;67(2):383-94. doi: 10.1086/303003. Epub 2000 Jun 21.

  PMID: 10869235 BACKGROUND

MeSH Terms

Conditions

Diabetic Retinopathy; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Endocrine System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Catherine Meyerle, M.D.

  National Eye Institute (NEI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH

Study Record Dates

• First Submitted: July 22, 2010
• First Posted: July 23, 2010
• Study Start: July 7, 2010
• Study Completion: August 7, 2013
• Last Updated: October 6, 2017

Record last verified: 2013-08-07

Locations

US (1)