Retrospective Analysis of Naive Patients With Age-related Macular Degeneration Neovascular Type and Treated With Ranibizumab (Lucentis®) in Treat-and-extend at the CHU Brugmann.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Injections interval
研究概览
简要总结
Age-related macular degeneration (AMD) is a leading cause of blindness in people over 50 years old. Neovascular AMD, the most severe form and the most severe is characterized by the appearance, spread and growth of subretinal neovessels. One of the major molecular mediators is the endothelial growth factor vascular (VEGF).
Intra-vitreous (IVI) injection of an anti-VEGF may slow the progression of Neovascular AMD and stabilize vision in the majority of cases. Ranibizumab (Lucentis®) is one of the anti-VEGF molecules approved in Belgium to treat neovascular AMD.
At the start of its use, ranibizumab was first injected monthly and then according to the "reactive" protocol. Over time, a new strategy of treatment was born: the "treat-and-extend" (T&E). This is 'made to measure' protocol for each patient aiming to reduce the frequency of injections while guaranteeing inactivity of the disease. It starts with the loading dose, i.e. 3 injections given 4 weeks apart. Subsequently, the interval is lengthened by slices of 1 or 2 weeks provided that the visual and anatomical results remain stable. In the event of deterioration, the interval is shortened while keeping a minimum of 4 weeks between each IIV.
The efficacy and safety of ranibizumab, when used in a proactive regimen of T&E, has been shown in the CANTREAT randomized controlled trial. However, there is a lack of more data on T&E used in current practice, and particularly on the number of injections and treatment intervals over a minimum treatment period of 24 months.
The aim of this retrospective study carried out at the CHU Brugmann Hospital is to determine the number of injections and the intervals necessary to have encouraging results in visual acuity over a treatment period of at least two years.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients> 50 years old diagnosed with neovascular age related macular degeneration,
- •Patients who have never received anti-VEGF treatment,
- •Patients who started intra-vitreous injections of ranibizumab between 01 January 2014 and November 30, 2019,
- •Treatment by "treat-and-extend" directly after the loading dose of ranibizumab,
- •Availability of the medical file reporting treatment with ranibizumab.
排除标准
- •Participation in an interventional clinical study during treatment with ranibizumab,
- •Patients suffering from ocular pathologies and having required surgery during the first 24 months of treatment with ranibizumab (for example advanced glaucoma or cataract).
结局指标
主要结局
Injections interval
时间窗: during the 2nd year of treatment
Last injection interval during the 2nd year of treatment, in weeks
Injections number (first 24 months of treatment)
时间窗: first 24 months of treatment
Number of injections during the first 24 months of treatment
次要结局
- Number of follow-up visits(up to 4 years of treatment)
- Visual acuity(up to 4 years of treatment)
- Eye lesion type(Baseline)
- Retinal thickness(up to 4 years of treatment)
- Number of patients stopping treatment (24-36 months)(between 24 and 36 months of treatment)
- Overall extension interval(up to 4 years of treatment)
- Reason for stopping treatment (24-36 months)(between 24 and 36 months of treatment)
- Number of patients stopping treatment (36-48 months)(between 36 and 48 months of treatment)
- Number of patients stopping treatment (12-24 months)(between 12 and 24 months of treatment)
- Injection number (up to 4 years of treatment)(up to 4 years of treatment)
- Covid 19 impact(up to 4 years of treatment)
- Reason for stopping treatment (36-48 months)(between 36 and 48 months of treatment)
- Most stable injection interval(up to 4 years of treatment)
- Age(Baseline)
- Fluid(once a year up to 4 years of treatment)
- Date of first injection(Baseline)
- Treatment regimen(first 12 months of treatment])
- Injections interval (up to 4 years of treatment)(up to 4 years of treatment)
- Date of first symptoms(Baseline)
- Reason for stopping treatment (12-24 months)(between 12 and 24 months of treatment)
- Number of patients stopping treatment (first 12 months)(First 12 months of treatment)
- Reason for stopping treatment (first 12 months)(First 12 months of treatment)
研究者
Laurence Postelmans
Head of ophtalmology department
Brugmann University Hospital