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临床试验/NCT03630562
NCT03630562已完成不适用

Assay of Pro-angiogenic Cytokines in Exudative Age-Related Macular Degeneration

Centre Hospitalier Universitaire de Nice1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2018年11月26日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
1
主要终点
Change of pro-angiogenic cytokines concentration in the aqueous humor of patients with exudative AMD at 3 months

研究概览

简要总结

Anti-VEGF intravitreal injections are the treatment of choice in age-related macular degeneration (AMD). However 37% of patients are unresponsive or poorly responsive to these therapies. It is still not possible to foresee the patient's response to anti-VEGF injections. A poor response may be related to an activation of alternative pro-angiogenic pathways with over expression of many other pro-angiogenic cytokines.

The primary goal of this study is to measure the aqueous humor concentration of pro-angiogenic cytokines in AMD patients.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

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

  • Age > 18 years
  • Diagnosis of exudative age-related macular degeneration requiring intravitreal anti-VEGF treatment.
  • Patient for whom the last intravitreal injection of anti-VEGF in the eye is strictly more than 3 months
  • Signature of informed consent
  • Affiliation to the French social security system

排除标准

  • Pregnant or nursing patient (a urinary pregnancy test will be performed)
  • Systemic treatment with anti-VEGF
  • Intravitreal treatment with anti-VEGF for less than 3 months regardless of the treated eye.
  • Retinal pathology that can modify the secretion of pro-inflammatory cytokines such as diabetic retinopathy, venous occlusions, intermediate and posterior uveitis.
  • Diabetes Mellitus
  • High Myopia
  • Simultaneous participation in another clinical research protocol in exudative AMD
  • Person under guardianship, under curatorship, deprived of liberty

结局指标

主要结局

Change of pro-angiogenic cytokines concentration in the aqueous humor of patients with exudative AMD at 3 months

时间窗: At Month 3

次要结局

  • Dose of VEGF in the aqueous humor of patients with exudative AMD(At Day 0, Month 1, Month 2, Month 3)
  • Dose of pro inflammatory cytokines in the aqueous humor of patients with exudative AMD(At Day 0, Month 1, Month 2, Month 3)
  • Measurement of visual acuity with Snellen chart(At Day 0, Month 1, Month 2, Month 3)
  • Measurement of visual acuity with ETDRS visual acuity chart(At Day 0, Month 1, Month 2, Month 3)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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