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临床试验/NCT01168258
NCT01168258终止不适用

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

National Eye Institute (NEI)1 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2010年7月7日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
68
试验地点
1
主要终点
Genotype frequency of SNP in the study genes of DME participants and control participants.

研究概览

简要总结

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.

详细描述

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 advanced glycation end product (RAGE) genes are associated with the development of diabetic macular edema (DME).

Study Population:

Two hundred case participants with DME and 200 diabetic controls without DME will be enrolled.

Design:

研究设计

研究类型
Observational
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

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

次要结局

  • 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.

研究者

申办方类型
Nih

研究点 (1)

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