Plasma Levels of Vascular Endothelial Growth Factor Before and After Intravitreal Injection of Aflibercept in Patients With Exudative Age-related Macular Degeneration
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 主要终点
- Mean change in VEGF plasma concentration (pg/mL)
研究概览
简要总结
The purpose of this study is to examine the plasma concentration of vascular endothelial growth factor (VEGF) after standard treatment with one of the newest growth factor inhibitors, aflibercept (Eylea).
Patients with exudative age-related macular degeneration (AMD) are treated today with anti-growth factors (anti-VEGF). Eylea appears to have a longer duration of action in the eye and a more powerful effect on the edema in the macula than previously used growth factor inhibitors. This means that the disease can be controlled with fewer number of injections into the eye and the investigators can therefore reduce the risk of complications associated with this type of treatment.
It is unclear what the plasma VEGF concentration after treatment with Eylea into the eye in patients with wet age-related macular degeneration is.
详细描述
Macular edema secondary to exudative age-related macular degeneration is treated today primarily with vascular endothelial growth factor inhibitors, anti-VEGF.
There are currently four anti-VEGF drugs that are either approved or off-label used in ophthalmology. Pegaptanib (Macugen, Pfizer), ranibizumab (Lucentis, Novartis) aflibercept (Eylea, Bayer) and bevacizumab Avastin, Roche) . They have different molecules and pharmacodynamics .
VEGF plays an important role in many physiological and pathophysiological mechanisms. Studies have shown that even low-dose intravitreal treatment with bevacizumab leads to significant reduction of VEGF plasma concentration up to a month after treatment in patients with exudative AMD.
No significant systemic effect could be detected after intravitreal administration of ranibizumab or pegaptanib.
The purpose of this study is :
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women with exudative AMD
- •Central Retinal Thickness ≥ 250 microns
- •Best corrected visual acuity 20/25-20/320
- •Age ≥ 60 years
- •Only one eye will be applicable for recruitment
- •Informed signed consent according to International Conference on Harmonisation Good Clinical Practice should be in place prior to study .
排除标准
- •Bilateral disease
- •Treatment with intravitreal injections in the past three months
- •Patients who have previously undergone vitrectomy
- •Choroidal neovascular membrane secondary to other disease than AMD
- •Macula edema of other etiology than wet AMD
- •Intraocular pressure ≥ 30 mmHg in mydriasis
- •Active uveitis or infectious condition in the study eye
- •Patients using systemic anti inflammatory therapy ( steroids)
- •Patients using systemic anti-VEGF treatment
- •Blod pressure which is not well regulated
- •Dialysis or in need of transplantation resulting from renal failure
- •Heart attack, stroke, transient ischemic attack in the last 6 months
- •New York Heart Association class II , III , IV
- •Known allergy to aflibercept , fluorescein or povidone iodine
- •Unable to follow the study procedures
结局指标
主要结局
Mean change in VEGF plasma concentration (pg/mL)
时间窗: 6 months
次要结局
- Number of non-responders(6 months)
- Central Retinal Thickness as measured by Optical coherence tomography expressed in microns(6 months)
- Mean change in Visual Acuity as measured with the Snellen chart(6 months)
研究者
ANCA ROALD
MD, PhD
Oslo University Hospital