Enhancing the Lucentis (Ranibizumab) Management of Choroidal Neovascular Membranes With Hyperspectral Imaging
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Hyperspectral image characteristics that predict response of choroidal neovascularisation to Lucentis
研究概览
简要总结
Clinical trial investigating the role of hyperspectral imaging in the management of patients undergoing standard clinical treatment for naive neovascular choroidal membranes in age-related macular degeneration.
详细描述
Observational trial of patients with choroidal neovascular membranes treated with Lucentis. Exploration and validation of a new form of retinal imaging called hyperspectral imaging.
Inclusion: Patients meet eligibility criteria other than FFA diagnosis and who are diagnosed with suspected exudative CNV on the OCT. (n=100 eyes) Procedure: Monthly doses of Lucentis. OCT scans will be taken prior to each injection. HSI image taken at baseline and at the 9-month time point.
Time frame: 6 months recruitment + 12 months follow-up + 6 months analysis.
All recruited patients will receive monthly doses of Lucentis as per the CMBS-approved protocol to allow comparison with other published studies. Lucentis will be administered in accordance with published standards of practice.
OCT scans will be taken prior to each injection. HSI image will be taken at baseline, three months and 9-month time points
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
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Provide signed and dated informed consent form
- •Willing to comply with all study procedures and be available for the duration of the study
- •Male or female, aged 50-80
- •In sufficiently good general health to be able to have a FFA
- •CNV diagnosed by OCT
- •Vision equal or better than 6/60 in the study eye
- •No prior treatment in the study eye with anti-VEGF medication
- •Exclusion Criteria
- •Significant media opacity.
- •Known allergic reactions to components of the study product(s).
- •Anything that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study.
排除标准
- 未提供
结局指标
主要结局
Hyperspectral image characteristics that predict response of choroidal neovascularisation to Lucentis
时间窗: 3-9 months
Hyperspectral images will be analysed to define specific characteristics that identify which types of choroidal neovascularisation will respond to Lucentis. Responsive patients will be differentiated from non-responders and distinguishing image features will be identified.
次要结局
- Specific spectral signature for identification of exudative AMD(3-9months)
研究者
Marc Sarossy
Dr
Center for Eye Research Australia