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临床试验/NCT04439708
NCT04439708招募中不适用

Biomarkers Analysis of Mineralocortoid Receptor Activation in the Serum and Ocular Fluid of Patients With Choroidal Neovascularization

Institut National de la Santé Et de la Recherche Médicale, France4 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2020年7月6日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
250
试验地点
4
主要终点
biomarker analysis in blood and aqueous humor of patients with neovascularization and controls

研究概览

简要总结

The aim of the study is to find biomarkers in the blood and aqueous humor of patients with type 1 choroidal neovascularization and correlate them with the response to anti-VEGF treatment.

详细描述

Age-related macular degeneration (AMD) is the most frequent cause of blindness in industrialized countries. Multiple molecular pathways have been implicated in the pathogenesis of choroidal neovascularization (CNV). Currently, the treatment relies on neutralization of VEGF (Vascular Endothelial Growth Factor). However some patients have an incomplete response to anti-VEGF treatment. A recent study suggested the implication of the mineralocorticoid receptor pathway in the formation of CNV.

The study (of investigators) aim is to evaluate the concentation of metabolites of MR pathway in the blood and aqueous humor of patients with CNV and compared them with patients without CNV in order to increase our understanding of CNV pathogenesis and find potential biomarker of response to anti-VEGF treatment.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients of group 1:
  • Patients with type 1 choroidal neovascularization in a context of central serous chorioretinoathy or age related macular degeneration
  • Patients without intravitreal injection or last intravitreal injection > 3 months
  • Informed signed consent
  • Patients of group 2:
  • Patients without choroidal neovascularization
  • Patients with intraocular surgery (cataract or vitrectomy surgery)
  • Signed consent

排除标准

  • Myocardial infarction < 12 months
  • Chronic renal failure
  • Inflammatory disease
  • Infectious disease :HIV, viral hepatitis, tuberculosis
  • Type 1 or 2 Diabetes
  • Patients treated by mineralocorticoid antagonist treatment.
  • Type 2 or 3 choroidal neovascularization
  • Pregnant woman

结局指标

主要结局

biomarker analysis in blood and aqueous humor of patients with neovascularization and controls

时间窗: 24 months

Biomarker concentrations (pg/ml) will be evaluated with ELISA (Enzyme Linked ImmunoSorbent Assay).

次要结局

  • biomarkers and treatment response(24 months)

研究者

发起方
Institut National de la Santé Et de la Recherche Médicale, France
申办方类型
Other Gov
责任方
Sponsor

研究点 (4)

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