Targeted Fluorescence Imaging Using Bevacizumab-800CW Within Age-related Macular Degeneration (AMD) Patients to Evaluate the Upregulation of VEGF
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Feasibility: the possibility of measuring the specific uptake of fluorescence within the eye using both scanning laser angiography and optical coherence tomography.
研究概览
简要总结
Rationale:
To track performance of intravitreal distribution of anti-VEGF-A (Bevazicumab-800CW) and provide information about neovascularization and inflammation in Age-Related Macular Degeneration (AMD), thereby predicting progression and optimizing treatment
Objective:
To determine the safety and feasibility of fluorescence imaging of the eye with the fluorescent tracer bevacizumab-800CW for identification AMD with scanning laser angiography
Study design:
A non-randomized, non-blinded, prospective, single-center feasibility study.
Study population:
Patients group: patients with naïve wet AMD and wet AMD aged >60 years old with current treatment of anti-VEGF intravitreal.
Control group: patients with naïve wet AMD and wet AMD aged >60 years old with current treatment of anti-VEGF intravitreal
Intervention (if applicable):
Intravenous injection of bevacizumab-800CW in the patient group.
Main study parameters/endpoints:
Safety and feasibility of the intravenous tracer bevacizumab-800CW in patients with naïve wet AMD and wet AMD by observing the uptake in retinal, choroid and neovascular tissue.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: No risk described in other (running) studies on intravenous injection with bevacizumab-800 CW. Patients need to come back 48-96 hours after injection and the eye measurements take about half an hour longer.
There is no benefit with participation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 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
- •Patients with either naïve wet AMD or wet AMD receiving standard care of anti-VEGF therapy
- •Aged >60 years old
- •Optional: Patients already included in fluorescence study which involves Bevacizumab-800CW
排除标准
- •Eye pathology interfering with retinal imaging;
- •Patients with psychological diseases or medical issues who are not able to sign informed consent form;
- •Concurrent uncontrolled medical conditions;
- •Received a different investigational drug within 30 days prior to the dose of bevacizumab-800CW;
- •History of infusion reactions to bevacizumab or other monoclonal antibody.
研究组 & 干预措施
AMD with bevacizumab-800CW
Patients with AMD receive bevacizumab-800CW followed by angiography
干预措施: Bevacizumab-IRDye800CW (Drug)
结局指标
主要结局
Feasibility: the possibility of measuring the specific uptake of fluorescence within the eye using both scanning laser angiography and optical coherence tomography.
时间窗: Directly after administration until 96 hours after
The target-to-background radio will be measured during fluorescence imaging and compared with imaging before tracer administration.
Safety: number of participants with symptoms or changes in vital signs (blood pressure, heart rate and temperature) that are related to administration of bevacizumab-800CW
时间窗: Directly after administration until 96 hours after.
To determine the safety of bevacizumab-800CW in patients with AMD by monitoring of vital signs (blood pressure, heart rate and temperature), before and until one hour after administration.
次要结局
- Determination of the most optimal dose of bevacizumab-800CW for fluorescence imaging of the eye vascularization.(Directly after administration until 96 hours after.)
- Correlation of the fluorescence intensity, target-to-background ratio (TBR), with disease identification(Up to 1 year)
- Correlation between fluorescence intensity and clinical score(Up to 1 year)
- Correlation of VEGF expression within the tear fluid with the fluorescent signal(Up to 1 year)