Retrospective Multicenter Real-world Observational Study of Switching to Aflibercept 8 mg in Patients With Refractory or Dependent Exudative Age-related Macular Degeneration
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change in intravitreal injection interval
研究概览
简要总结
Age-related macular degeneration is a leading cause of visual impairment in older adults. In its exudative form, repeated intravitreal injections of anti-VEGF agents are required to control disease activity. A new formulation of aflibercept at a higher dose (8 mg) has been developed with the aim of extending the interval between injections.
This multicenter retrospective real-world observational study will evaluate the effect of switching to aflibercept 8 mg in patients with refractory or dependent exudative age-related macular degeneration. Clinical data collected during routine care will be analyzed to compare injection intervals, treatment burden, visual outcomes, anatomical outcomes, and safety before and after the switch.
详细描述
This is a multicenter, retrospective, real-world observational study conducted in patients with exudative age-related macular degeneration who were switched from a previous anti-VEGF therapy to aflibercept 8 mg as part of routine clinical care.
The study will include adult patients treated for exudative age-related macular degeneration for at least one year and switched to aflibercept 8 mg between January 2025 and July 2025 because of refractory disease or treatment dependence. Data will be collected retrospectively from medical records across participating centers in Western France.
Clinical outcomes will be assessed by comparing treatment intervals, number of intravitreal injections, number of ophthalmology visits, visual acuity, central macular thickness, and presence of intraretinal or subretinal fluid during the 12 months before and after the switch to aflibercept 8 mg. Safety outcomes will include the occurrence of ocular adverse events such as intraocular inflammation, endophthalmitis, and retinal complications.
Statistical analyses will include comparisons of quantitative and qualitative variables before and after the switch, as well as multivariable analyses to identify factors associated with greater extension of injection intervals.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (≥18 years) with exudative (neovascular) age-related macular degeneration
- •Treated with intravitreal anti-VEGF therapy for more than 1 year
- •Switched to aflibercept 8 mg before July 31, 2025
- •Injection interval strictly less than 12 weeks prior to switch
排除标准
- •High myopia (axial length > 26 mm or spherical equivalent < -6 diopters)
- •Angioid streaks
- •Moderate or severe diabetic retinopathy
- •History of diabetic macular edema
- •History of uveitis
- •History of retinal vein occlusion (branch or central)
- •History of pseudovitelliform macular dystrophy
- •Patient under legal guardianship or curatorship
- •Pregnant or breastfeeding women
研究组 & 干预措施
Aflibercept 8 mg Switch Cohort
Patients with exudative age-related macular degeneration switched from a previous anti-VEGF therapy to aflibercept 8 mg as part of routine clinical care.
干预措施: aflibercept 8 mg (Drug)
结局指标
主要结局
Change in intravitreal injection interval
时间窗: From 12 months before switch to 12 months after switch to aflibercept 8 mg
Difference in the number of weeks between intravitreal anti-VEGF injections before switching to aflibercept 8 mg and after 12 months of treatment with aflibercept 8 mg, or at the last observed interval in case of switch to another molecule.
次要结局
- Injection-free interval without exudative recurrence(From 12 months before switch to 12 months after switch)
- Number of intravitreal injections(12 months before and 12 months after switch)
- Number of ophthalmology visits(12 months before and 12 months after switch)
- Change in visual acuity(Baseline (before switch) and 12 months after switch)
- Change in central macular thickness(Baseline (before switch) and 12 months after switch)
- Presence of intraretinal or subretinal fluid(Baseline (before switch) and 12 months after switch)
- Reswitch to another anti-VEGF therapy(Within 12 months after switch)