Study of the Modification of the Retinal Nerve Fiber Layer in Patients Treated With Intravitreous Injection of Anti-VEGF
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 3
- 主要终点
- change in RNFL's thickness in the nasal quadrant of the optic nerve after intra-vitreous Injection of Anti-VEGF
研究概览
简要总结
The intra-vitreous injection (IVT) of anti-VEGF (vascular endothelial growth factor) is currently the standard treatment for retinal neovascularization. The VEGF stimulates endothelial cells' proliferation and migration. It also increases microvascular permeability. If the VEGFs have proven their efficiency in the decrease of choroidal neovascular proliferation, their impact of the head of the optic nerve's microvasculature is yet unknown. Knowing that this microvasculature provides the retinal nerve fibers with oxygen, located in the area of the head of the optic nerve, a vasoconstriction induced by the anti-VEGF may have an incidence on the loss of retinal nerve fibers.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- 否
入选标准
- •Age ≥18 years old
- •Patients treated with anti-VEGF according to the French summary of product characteristics (SPC)
- •Patients who have been informed of the trial and who are not opposed to participate in the study
排除标准
- •Patients presenting a retinal condition, including the optic nerve
- •Patients treated with anti-VEGF in both eyes
- •Pregnant women
- •Lack of affiliation to social security or universal health coverage
结局指标
主要结局
change in RNFL's thickness in the nasal quadrant of the optic nerve after intra-vitreous Injection of Anti-VEGF
时间窗: Change from baseline RNFL's thickness at Month 12
RNFL's thickness (in microns) measured with the Heildelberg glaucoma module of the spectral domain Optical Cohérence Tomographie (OCT Spectralis, Heidelberg engeening).
次要结局
未报告次要终点