sCD160 in Sera and Intra-ocular Fluids: Association With Ischaemic Retinopathies
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- CHU de Reims
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- sCD160 concentration in the aqueous humor
研究概览
简要总结
CD160 represents a new angiogenic factor as its specific engagement by an agonist monoclonal antibody directed against human CD160 reduced angiogenesis of endothelial cells with a distinct mechanism from current angiogenic therapies that target the VEGF/VEGF-R pathway. A soluble form of CD160, sCD160, has been found to be highly expressed in the vitreous and the sera of patients with severe diabetic retinopathies, and can now be dosed with help of an ELISA test.
The investigators aim to evaluate the association between ischaemic retinopathies (patients with or without) and sCD160 concentrations in the vitreous, the aqueous humour and the serum.
详细描述
120 patients enrolled for ophthalmic surgery (cataract or posterior segment surgery (epiretinal membrane, macular hole, vitrectomy)) will be recruited in the Department of Ophthalmology, Robert Debré Hospital, Reims, France.
Each patient will benefit a complete ophthalmologic examination, and either an aqueous sampling (cataract) or a vitreous sampling (posterior segment) along with a serum sampling at the beginning of the surgery. ELISA test will be performed on vitreous or aqueous samples in triplicates. Luminex will be performed on vitreous samples in order to determine the concentrations of several ischemia biomarkers (VEGF, PlGF, Platelet-derived growth factor (PDGF-B), SDF-1, Angpt2, InterIeukin IL-6, IL-8, CD105, Monocyte chemoattractant protein 1 (MCP-1), IL-10, interferon-inducible protein-10 ( IP-10), IL-1B and CD106, RAGE).
Primary objective is:
- Evaluation of the association between ischaemic retinopathies (patients with or without) and sCD160 concentrations of the vitreous or the aqueous humours.
Secondary objectives are:
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
- 否
入选标准
- •over 18 years old
- •with social security affiliation
- •willing to participate this study non-inclusion criteria :
- •any prior (3 months) or concomitant treatment with anti-VEGF therapy, corticosteroids, or immunosuppressive agents
- •any history of previous vitreoretinal surgery, ocular tumor, severe ocular trauma, severe intraocular, periocular infection, inflammation, or radiation
- •any serious allergy to the fluorescein sodium for injection in angiography
- •any history of previous systemic anti-VEGF treatment
- •any history of inflammatory or auto-immune disease
- •any active extraocular inflammation or infection in the last 4 weeks before surgery
排除标准
- •Patients with C-reactive protein CRP > 10mg/mL (serum sampling during surgery)
研究组 & 干预措施
Patients with ophthalmic surgery
干预措施: sampling of ophthalmic liquid (Other)
结局指标
主要结局
sCD160 concentration in the aqueous humor
时间窗: Day 0
ELISA test
sCD160 concentration in the vitreous humor
时间窗: Day 0
ELISA test
次要结局
- Vascular endothelial growth factor (VEGF)(Day 0)
- Diabetic retinopathy severity(Day 0)
- sCD160 concentration in the serum(Day 0)
- Stromal cell-derived factor 1 (SDF-1)(Day 0)
- Placenta Growth Factor-1(PlGF)(Day 0)