Retrospective Analysis of naïve Patients With Age-related Macular Degeneration of the Neovascular Type and Treated With Aflibercept (Eylea®) in "Treat-and-extend" at CHU Brugmann
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Injections number (first 24 months of treatment)
研究概览
简要总结
Age-related macular degeneration (AMD) is a leading cause of blindness in people over 50. Neovascular AMD, the most serious and severe form, is characterized by the appearance, spread and growth of subretinal new vessels. One of the major molecular mediators is vascular endothelial growth factor (VEGF).
Intra-vitreous (IVI) injection of an anti-VEGF can slow the progression of neovascular AMD and stabilize vision in the majority of cases. Aflibercept (Eylea®) is one of the anti-VEGF molecules approved in Belgium to treat neovascular AMD.
At the start of its use, aflibercept was first injected monthly and then according to the PRN "reactive" protocol (Pro Renata). Over time, a new treatment strategy has emerged: the "treat-and-extend" (T&E). This is individualized patient care, the objective of which is to reduce the frequency of injections while ensuring inactivity of the disease. This begins with the loading dose, i.e. 3 injections given 4 weeks apart. Thereafter, the interval is lengthened in increments 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 IVI.
The efficacy and safety of aflibercept, when used in a proactive T&E regimen, was demonstrated in the randomized controlled trial, ALTAIR. However, data on T&E used in practice is still lacking. routine, and particularly the number of injections and treatment intervals over a minimum 24 month treatment period.
The aim of this retrospective study carried out at the CHU Brugmann is to determine the number of injections and the intervals necessary to have encouraging results in terms of visual acuity, over a treatment period of at least one year.
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 aflibercept between 01 January 2014 and November 30, 2019,
- •Treatment by "treat-and-extend" directly after the loading dose of aflibercept,
- •Availability of the medical file reporting treatment with aflibercept.
排除标准
- •Participation in an interventional clinical study during treatment with aflibercept,
- •Patients with ocular pathologies who required surgery during the first 24 months of treatment with aflibercept (eg advanced glaucoma or cataracts).
结局指标
主要结局
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
Injections interval
时间窗: during the 2nd year of treatment
Last injection interval during the 2nd year of treatment, in weeks
次要结局
- Number of patients stopping treatment (12-24 months)(between 12 and 24 months of treatment)
- Visual acuity(up to 4 years of treatment)
- Age(Baseline)
- 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)
- Reason for stopping treatment (24-36 months)(between 24 and 36 months of treatment)
- Injections interval (up to 4 years of treatment)(up to 4 years of treatment)
- Most stable injection interval(up to 4 years of treatment)
- Covid 19 impact(up to 4 years of treatment)
- Number of patients stopping treatment (36-48 months)(between 36 and 48 months of treatment)
- Reason for stopping treatment (36-48 months)(between 36 and 48 months of treatment)
- Injection number (up to 4 years of treatment)(up to 4 years of treatment)
- Fluid(up to 4 years of treatment)
- Date of first symptoms(Baseline)
- Date of first injection(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)
- Overall extension interval(up to 4 years of treatment)
- Number of follow-up visits(up to 4 years of treatment)
- Treatment regimen(first 12 months of treatment)
- Reason for stopping treatment (first 12 months)(first 12 months of treatment)
研究者
Laurence Postelmans
Head of Opthalmology clinic
Brugmann University Hospital