Observational Study to Evaluate Fluid Resolution and Effectiveness of Brolucizumab for Neovascular Age-related Macular Degeneration (nAMD) in Portugal
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 81
- 试验地点
- 1
- 主要终点
- Percentage of patients that are absent of subretinal fluid (SRF) and intra-retinal fluid (IRF) in the study eye
研究概览
简要总结
This study is a prospective, observational, non-interventional, multicenter, open-label, single arm study in patients being treated for nAMD with brolucizumab in Portugal.
详细描述
Naïve and pre-treated patients will be included after decision to start treatment with brolucizumab and consent is given.
The baseline visit will be used to assess eligibility and collect baseline characteristics information. The study eye will be defined as the first eye treated during the study; the other eye will be considered as fellow eye. If both eyes are treated at baseline, the eye with the worse visual acuity will be chosen as the study eye (if the visual acuity is measured equal, the treating ophthalmologist defines the study eye upon his discretion). The follow-up visits will take place at a frequency defined as per investigator's discretion. Patients that have not received an intravitreal anti-VEGF injection or visited an eye specialist for at least 6 months will be discontinued from the observation.
Retrospective data will be collected for switch patients starting treatment with brolucizumab for up to six months before baseline. Patients, already being treated with brolucizumab may also be included. Here, retrospective data will be collected since the first brolucizumab injection.
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
- 40 Years 至 110 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of nAMD
- •Male and Female patients with ≥40 years of age at index
- •Receipt of at least one injection of brolucizumab during the recruitment period
- •Signed written informed consent
排除标准
- •Patients treated for RVO, DME, mCNV, and have diagnoses of diabetes-related macular degeneration within 6 months prior to the index date
- •Receipt of any anti-VEGF treatment other than brolucizumab in the study eye at index date
- •Central subfield of the study eye affected by fibrosis or geographic atrophy or total area of fibrosis >50% of the total lesion in the study eye at Screening
- •Any active intraocular or periocular infection or active intraocular inflammation in either eye at index date
- •Patients who have been on anti-VEGF treatment for longer than 3 years (before index date)
- •Patients that have any contraindication and are not eligible for treatment with brolucizumab as according to the SmPC
- •Any medical or psychological condition in the treating physician's opinion which may prevent the patient from the 24 months study participation
- •Patients participating in parallel in an interventional clinical trial
- •Patients participating in parallel in any other NIS generating primary data for an anti-VEGF drug
- •Retinal pigment epithelial rip/tear in the study eye at Screening or Baseline or current vitreous hemorrhage or history of vitreous hemorrhage in the study eye within 4 weeks prior to Baseline
- •Subretinal blood affecting the foveal center point and/or >50% of the lesion of the study eye at Screening
研究组 & 干预措施
Brolucizumab
Naïve (Patients being the first time treated) and pre-treated patients
干预措施: Brolucizumab (Drug)
结局指标
主要结局
Percentage of patients that are absent of subretinal fluid (SRF) and intra-retinal fluid (IRF) in the study eye
时间窗: month 12
This primary study objective will be addressed considering treatment naïve and pre-treated patient eyes included in the study, analyzed as two independent groups (naïve and switch).
次要结局
- Fluid resolution after initiation of brolucizumab(month 24)
- Visual Actuity (VA) change from baseline(Baseline, month 24)
- Characterize Choroidal Neovascularization (CNV) morphology (BIRL) and activity(month 24)
- Number of injections and total number of visits(month 24)
- Describe the distribution of injection intervals(month 24)
- Characterize the patients switching to another antivascular endothelial growth factor (anti-VEGF)(month 24)
- Number of Spectral Contrast Optical Coherence Tomography (SC-OCTs) done(month 24)
- Discontinuation rate(month 24)
- Assess the safety of brolucizumab(month 24)