An Observational Study Program to Investigate the Effectiveness of Aflibercept 8 mg Used in DME and nAMD in a Real-world Setting
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 2,500
- 试验地点
- 18
- 主要终点
- The change of best corrected visual acuity (BCVA) from baseline to 12 months as evaluated in routine clinical practice
研究概览
简要总结
This is an observational study in which only data are collected from people who have already been prescribed aflibercept 8 mg by their own doctors.
In this study, data from adults with visual impairment due to neovascular age-related macular degeneration (nAMD) or diabetic macula edema (DME) will be collected and studied.
Visual impairment is any degree of vision loss that affects a person's ability to perform daily activities. nAMD is an eye disorder that causes vision loss due to the growth of abnormal blood vessels that leak blood or retinal fluid into the macula (the central part of the retina). nAMD is a leading cause of vision loss for people aged 50 and older. DME is a diabetes-related eye disorder. In DME, the macula swells up due to fluid leakage from damaged blood vessels, resulting in vision problems.
Aflibercept 8 mg is a drug that is injected into the eye. It works by blocking a protein called vascular endothelial growth factor (VEGF) which causes abnormal growth and leakage of blood vessels at the back of the eye.
Aflibercept 8 mg has been submitted for approval for the treatment of visual impairment due to nAMD and DME based on the results from 2 studies called PHOTON and PULSAR. This study will begin once approval is obtained. Currently, no real-world data are available for aflibercept 8 mg.
The main purpose of this study is to collect more information about how well aflibercept 8 mg injection works in people with nAMD and DME. This study will include participants who have not received any prior treatment for nAMD or DME and participants who have.
The main information that researchers will collect:
the change in vision test scores called the best corrected visual acuity (BCVA) after 12 months of treatment.
Data will be collected from February 2024 to September 2027 and will cover a period of up to 24 months per participant. The data will be collected using medical records and by interviewing the patients during regular visits that take place in routine practice.
Researchers will observe participants from the first injection of aflibercept 8 mg until the end of the observation.
In this study, only available data from regular visits will be collected. No visits or tests are required as part of this study.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion criteria for patients with nAMD
- •A diagnosis of nAMD
- •Patient aged ≥50 years
- •Patients for whom the decision to initiate treatment with intravitreal (IVT) aflibercept 8 mg according to a local product information was made as part of routine clinical practice
- •Signed informed patient consent before the start of data collection (according to the requirements of the local authorities and laws)
- •Inclusion criteria for patients with DME
- •A diagnosis of DME
- •Patient aged ≥18 years (or country's legal age of adulthood if the legal age is >18 years) with type 1 or type 2 diabetes mellitus
- •Patients for whom the decision to initiate treatment with IVT aflibercept 8 mg according to a local product information was made as part of routine clinical practice
- •Signed informed patient consent before the start of data collection (according to the requirements of the local authorities and laws)
排除标准
- •Exclusion criteria for all patients with nAMD
- •Participation in an investigational program with interventions outside of clinical routine practice
- •Contraindications as listed in the local intravitreal aflibercept 8 mg local product information
- •Extra/periocular infection or inflammation in either eye at time of first injection
- •Patient receiving other intravitreal treatments other than aflibercept in the fellow eye
- •Any medication interfering with aflibercept 8 mg in the intravitreal aflibercept 8 mg local product information Additional exclusion criteria for treatment-naïve patients with nAMD
- •Any prior ocular treatment in the study eye or systemic treatment in nAMD Additional exclusion criteria for pretreated patients with nAMD
- •Prior intravitreal anti-VEGF treatments in the study eye within the last 28 days
- •Prior treatment with intravitreal corticosteroid in the study eye within the last 3 months
- •Fluocinolone implant in the study eye within the last 3 years
- •Dexamethasone implant in the study eye within the last 6 months
- •Any concurrent drug releasing implant in the study eye
- •Exclusion criteria for all patients with DME
- •Participation in an investigational program with interventions outside of clinical routine practice
- •Contraindications as listed in the intravitreal aflibercept 8 mg local product information
- •Extra/periocular infection or inflammation in either eye at time of first injection
- •Patient receiving other intravitreal treatments other than aflibercept in the fellow eye
- •Any medication interfering with aflibercept 8 mg in the intravitreal aflibercept 8 mg local product information
- •Previous treatment of the study eye with laser in the last 90 days prior to first IVT aflibercept 8 mg Additional exclusion criteria for treatment-naïve patients with DME
- •Any prior ocular treatment in the study eye or systemic treatment in DME Additional exclusion criteria for pretreated patients with DME
- •Prior intravitreal anti-VEGF treatments in the study eye within the last 28 days
- •Prior treatment with intravitreal corticosteroid in the study eye within the last 3 months
- •Fluocinolone implant in the study eye within the last 3 years
- •Dexamethasone implant in the study eye within the last 6 months
- •Any concurrent drug releasing implant in the study eye
研究组 & 干预措施
naïve nAMD
Treatment-naive patients with nAMD
干预措施: Aflibercept 8 mg (VEGF Trap-Eye, BAY86-5321) (Drug)
pretreated nAMD
Pretreated patients with nAMD
干预措施: Aflibercept 8 mg (VEGF Trap-Eye, BAY86-5321) (Drug)
naïve DME
Treatment-naïve patients with DME
干预措施: Aflibercept 8 mg (VEGF Trap-Eye, BAY86-5321) (Drug)
pretreated DME
Pretreated patients with DME
干预措施: Aflibercept 8 mg (VEGF Trap-Eye, BAY86-5321) (Drug)
结局指标
主要结局
The change of best corrected visual acuity (BCVA) from baseline to 12 months as evaluated in routine clinical practice
时间窗: At baseline and 12 months
BCVA measurements at baseline (first injection of aflibercept 8 mg) and at 12 months as ETDRS letters (according to the Early Treatment Diabetic Retinopathy Study (ETDRS) chart or other methods (e.g. Snellen charts) used in the routine clinical practice in participating countries or sites (with conversion to ETDRS))
次要结局
- Change in central retinal thickness as measured by optical coherence tomography (OCT) from baseline to 4 weeks, 8 weeks, 6, 12, and 24 month follow up(At baseline, 4 weeks, 8 weeks, 6, 12 and 24 months)
- Number of aflibercept 8 mg injections in the study eye during the first 6 months, the first year (12 months), the second year (24 months), and the entire observation period (last visit), respectively(Up to 24 months)
- Number of visits regarding the study eye by type of visit during the first 6 months, the first 12 months, and the 24 months treatment period(Up to 24 months)
- Number of treated study eyes with 5, 10, and 15 letters (or equivalent) BCVA gain/loss from baseline at 4 weeks, 8 weeks, 6, 12, and 24 months(At baseline, 4 weeks, 8 weeks, 6, 12 and 24 months)
- The change of best corrected visual acuity (BCVA) from baseline to 4 weeks, 8 weeks, 6 months, and 24 months as evaluated in routine clinical practice(At baseline, 4 weeks, 8 weeks, 6 months and 24 months)
- Number of participants with (serious) adverse events and (serious) drug-related adverse events(From the first application of aflibercept 8 mg up to 24 months)