NCT02540369已完成不适用
PEGASUS: A Prospective obsErvational Study in Patients With Wet aGe-related Macular Degeneration or Diabetic Macular Edema to ASsess the Use of Intravitreal Aflibercept in roUtine Clinical practiceS in Canada
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 2,150
- 主要终点
- Mean change of visual acuity.
研究概览
简要总结
To describe the use of intravitreal aflibercept in routine clinical practice and to describe follow-up as well as treatment patterns in patients with wAMD or DME in routine clinical practice in Canada for a study population of treatment naive patients and those who have received prior therapy (anti-VEGF injections, laser, steroids, etc).
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
- •Age: >= 18 years of age
- •Male or female
- •Patients with wet AMD (wet age-related macular degeneration) or Diabetic macular edema (DME) who will be treated by intravitreal aflibercept according to the Canadian Product monograph recommendations and routine clinical practice.
- •Decision to treat with intravitreal aflibercept prior to patient enrolment as per the physician's routine clinical practice.
排除标准
- •Patients participating in an investigational program with interventions outside of routine clinical practice.
- •Patients currently being treated with intravitreal aflibercept. This study will only include patients new to intravitreal aflibercept, both naïve and previously treated with other anti-VEGF therapies.
- •Patients who are hypersensitive to this drug, to any ingredient in the formulation, or to any component of the container.
- •Patients who are hypersensitive to this drug, to any ingredient in the formulation, or to any component of the container.
- •Ocular or peri-ocular infection
- •Active intraocular inflammation
- •Scar, fibrosis, or atrophy involving the center of the fovea in the study eye.
- •Any concomitant therapy with another agent to treat wet AMD or DME in the study eye.
研究组 & 干预措施
BAY86-5321- with wAMD
Patients with wet Age Related Macular Degeneration (wAMD) both naïve and previously treated patients
干预措施: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321) (Drug)
BAY86-5321 - with DME
Patients with Diabetic Macular Edema (DME) both naïve and previously treated patients
干预措施: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321) (Drug)
结局指标
主要结局
Mean change of visual acuity.
时间窗: Baseline and 12 months
Treatment in naïve and previously treated patients for wAMD and DME.
次要结局
- Treatment patterns used in routine clinical practice setting.(Up to 12 months)
- Change of visual acuity.(Baseline and 12 months)
- Change of visual acuity by number of Injections.(Baseline and 12 months)
- Change in Retinal thickness.(Baseline and 12 months)
- Maximum interval between treatments.(Up to 12 months)
- Time to achieve stability of disease.(Up to 12 months)
- Number of injections in a year to achieve stability of disease.(Up to 12 months)
- Mean time between injections.(Up to 12 months)
- Number of injections at 12 months.(Up to 12 months)
- In previously treated subpopulation duration of previous treatments(At Baseline)
- Proportion of patients with no fluid determined by Optical coherence tomography (OCT).(At 4 months, At 12 months)
- Type of adjunctive therapies required by patients(Up to 12 months)
- Number of participants with adverse events as a measure of safety and tolerability.(Up to 12 months)
- In previously treated subpopulation type of previous treatments.(At Baseline)
- In previously treated subpopulation reason to switch to Eylea.(At Baseline)
- Presence of pigment epithelial detachment (PED) (Y/N)(Baseline and at 12 months)
- Diabetic retinopathy severity (mild, moderate, severe).(Up to 12 months)
- Numbers of patients require adjunctive therapies.(Up to 12 months)
研究者
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