Multicentre Observational Study to Investigate the Interval-Extension Potential, Effectiveness and Safety of Intravitreal Aflibercept 8 mg in Pretreated Eyes With Neovascular Age-Related Macular Degeneration (nAMD) or Diabetic Macular Oedema (DME) Under Routine Clinical Practice in Portugal
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 主要终点
- Last Achieved Treatment Interval Following Switch to Intravitreal Aflibercept 8 mg
研究概览
简要总结
The goal of this multicentre observational study is to evaluate the interval-extension potential, effectiveness, and safety of intravitreal aflibercept 8 mg in pretreated eyes with neovascular age-related macular degeneration (nAMD) or diabetic macular oedema (DME) under routine clinical practice in Portugal.
It consists in an ambidirectional longitudinal cohort with retrospective collection of pre-switch clinical and treatment history and prospective follow-up after initiation of intravitreal aflibercept 8 mg in routine clinical practice.
The main questions it aims to answer are:
- Can treatment intervals be extended after switching to intravitreal aflibercept 8 mg while maintaining disease control in pretreated eyes with nAMD or DME? What are the functional, anatomical, and safety outcomes associated with intravitreal aflibercept 8 mg in routine clinical practice?
Participants are adults with nAMD or DME who have previously received intravitreal treatment and are switched to aflibercept 8 mg as part of routine clinical care. No study-specific interventions or procedures are performed. Clinical data are collected prospectively through the Portuguese national Retina.PT registry during routine follow-up visits, including treatment patterns, injection intervals, visual acuity, retinal anatomical assessments, and ocular and systemic safety outcomes.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •Inclusion criteria - nAMD cohort
- •Diagnosis of neovascular age-related macular degeneration in the eye under treatment.
- •Patient aged ≥50 years at the time of the first aflibercept 8 mg injection.
- •The decision to initiate treatment with intravitreal aflibercept 8 mg, in accordance with the locally approved Summary of Product Characteristics, has been taken as part of routine clinical practice and independently of, and prior to, any decision to enroll the patient in the study.
- •The eye under treatment has previously received at least three (3) intravitreal injections of an anti-angiogenic agent prior to the first administration of aflibercept 8 mg.
- •Written informed consent has been provided by the patient (or legally acceptable representative) before the start of any study-related data collection, in accordance with applicable national and EU legislation.
- •Inclusion criteria - DME cohort
- •Diagnosis of diabetic macular edema in the eye under treatment, in a patient with established type 1 or type 2 diabetes mellitus.
- •Patient aged ≥18 years at the time of the first aflibercept 8 mg injection.
- •The decision to initiate treatment with intravitreal aflibercept 8 mg, in accordance with the locally approved Summary of Product Characteristics, has been taken as part of routine clinical practice and independently of, and prior to, any decision to enroll the patient in the study.
- •The eye under treatment has previously received at least three (3) intravitreal injections of an anti-angiogenic agent prior to the first administration of aflibercept 8 mg.
- •Written informed consent has been provided by the patient (or legally acceptable representative) before the start of any study-related data collection, in accordance with applicable national and EU legislation.
排除标准
- •applicable to both cohorts:
- •Concurrent participation in an interventional clinical investigation involving procedures outside routine clinical practice.
- •Any contraindication listed in the locally approved Summary of Product Characteristics for intravitreal aflibercept 8 mg.
- •Active extra-ocular or peri-ocular infection or active intraocular inflammation in either eye at the time of the first switch-related aflibercept 8 mg injection.
- •Pre-existing ophthalmological condition in the eye under treatment (other than nAMD or DME) that, in the investigator's judgment, could materially affect the assessment of study outcomes - for example, advanced uncontrolled glaucoma, optic neuropathy or other retinal pathology.
- •Concomitant use of any medicinal product whose interaction with intravitreal aflibercept 8 mg, as listed in the locally approved Summary of Product Characteristics, would compromise the assessment of treatment effect or patient safety.
- •Prior intravitreal anti-VEGF treatment in the eye under treatment within the 28 days preceding the switch/index date.
- •Prior intravitreal corticosteroid administration in the eye under treatment within the 3 months preceding the switch/index date.
- •Fluocinolone acetonide intravitreal implant in the eye under treatment within the 3 years preceding the switch/index date.
- •Dexamethasone intravitreal implant in the eye under treatment within the 6 months preceding the switch/index date.
- •Any other concurrent drug-releasing intravitreal implant in the eye under treatment.
- •Pregnancy at the time of the first switch-related aflibercept 8 mg injection.
- •Additional exclusion criterion - DME cohort only
- •Macular laser photocoagulation in the eye under treatment within the 90 days preceding the first intravitreal aflibercept 8 mg injection.
研究组 & 干预措施
DME Cohort
Pretreated eyes with diabetic macular oedema (DME) switched to intravitreal aflibercept 8 mg as part of routine clinical practice in Portugal. Treatment decisions, including the switch to aflibercept 8 mg and subsequent treatment intervals, are made independently of study participation. Participants are followed observationally using data collected during routine clinical care. This cohort includes eyes meeting all study eligibility criteria.
干预措施: Aflibercept 8mg (Drug)
nAMD Cohort
Pretreated eyes with neovascular age-related macular degeneration (nAMD) switched to intravitreal aflibercept 8 mg as part of routine clinical practice in Portugal. Treatment decisions, including the switch to aflibercept 8 mg and subsequent treatment intervals, are made independently of study participation. Participants are followed observationally using data collected during routine clinical care. This cohort includes eyes meeting all study eligibility criteria
干预措施: Aflibercept 8mg (Drug)
结局指标
主要结局
Last Achieved Treatment Interval Following Switch to Intravitreal Aflibercept 8 mg
时间窗: Months 6, 12, and 24 after initiation of intravitreal aflibercept 8 mg (where available).Months 6, 12, and 24 after initiation of intravitreal aflibercept 8 mg (where available).
The last achieved treatment interval (days) following initiation of intravitreal aflibercept 8 mg, defined as the interval between the two most recent consecutive aflibercept 8 mg injections documented within each analysis window. The endpoint is summarized descriptively to evaluate the interval-extension potential under routine clinical practice.
次要结局
- Change in Best-Corrected Visual Acuity (BCVA)(Baseline, Months 6, 12, and 24 (if available))
- Change in BCVA(Months 6, 12, and 24)
- Change in Central Retinal Thickness (CRT)(Baseline, Months 6, 12, and 24)
- Retinal Fluid Status(Months 6, 12, and 24 (if available))
- Number of Intravitreal Aflibercept 8 mg Injections(Up to 24 months)
- Ocular and Systemic Safety(From baseline to Month 24)