A Prospective Observational Study in Patients With Wet Age-related Macular Degeneration or Diabetic Macular Edema to Assess the freQuency of Use of Intravitreal Aflibercept in Routine Clinical Practices in Latin America
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 643
- 试验地点
- 1
- 主要终点
- Mean change of visual acuity as measured by ETDRS or Snellen chart
研究概览
简要总结
The main objectives of this observational cohort study are to describe the use of intravitreal aflibercept and to describe follow-up as well as treatment patterns in patients with wAMD or DME in routine clinical practice in Latin America for a study population of treatment naive patients and those who have received prior therapy (anti-VEGF injections, laser, steroids, etc.) and are being switched to intravitreal aflibercept 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
- 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 for DME patients,
- •Age: ≥55 for wAMD patients
- •Decision to treat with intravitreal aflibercept in the study eye prior to patient enrolment as per the physician's routine clinical practice and following the local Product monograph recommendations. Patients who are treatment naïve (no previous intravitreal treatment received, including, anti- VEGF agents, steroids, steroid implants and/or PDT) and patients that are switching from a different anti-VEGF therapy are both eligible to be included. DME patients that have received previous laser only will be classified as treatment naïve.
- •If of childbearing potential, female willing to use effective contraception during treatment and for at least 3 months after the last intravitreal injection of aflibercept
排除标准
- •Patients participating in an investigational program with interventions outside of routine clinical practice.
- •Patients currently being treated with intravitreal aflibercept in the study eye.
- •Patients who are hypersensitive to this drug, to any ingredient in the formulation, or to any component of the container. For a complete listing, see the DOSAGE FORMS, COMPOSITION AND PACKAGING section of the local product monograph.
- •Ocular or peri-ocular infection in either eye.
- •Active intraocular inflammation in the study eye.
- •Scar, fibrosis, or atrophy involving the center of the fovea in the study eye.
- •Patients with advanced glaucoma, visually significant cataracts, or any eye disease likely to require surgery during the study period in the study eye.
- •Concomitant ocular or systemic administration of drugs that could interfere with or potentiate the mechanism of action of intravitreal aflibercept, including anti-VEGF agents.
- •Patients receiving a different anti-VEGF agent other than intravitreal aflibercept for the fellow eye.
研究组 & 干预措施
Treatment naïve wAMD
The decision regarding treatment is made at the discretion of the attending physician, according to his/her medical practice
干预措施: Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321) (Drug)
Treatment naïve DME
The decision regarding treatment is made at the discretion of the attending physician, according to his/her medical practice
干预措施: Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321) (Drug)
Previously treated wAMD
The decision regarding treatment is made at the discretion of the attending physician, according to his/her medical practice
干预措施: Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321) (Drug)
Previously treated DME
The decision regarding treatment is made at the discretion of the attending physician, according to his/her medical practice
干预措施: Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321) (Drug)
结局指标
主要结局
Mean change of visual acuity as measured by ETDRS or Snellen chart
时间窗: At baseline and 12 months
ETDRS: Early treatment diabetic retinopathy study
次要结局
- Percentage of patients with no fluid determined by OCT(At 12 months)
- Percentage of patients gaining ≥15 ETDRS letter(At 12 months)
- Number of monitoring visits(At 12 months)
- Number of combined visits(At 12 months)
- Presence/absence of pigment epithelium detachments (PED)(At 12 months)
- Mean time between injections by indication(Up to 12 months)
- Mean number of injections by indication(At 12 months)
- Mean change in visual acuity as measured by ETDRS or Snellen chart(At baseline and 12 months)
- Change in retinal thickness as measured by OCT(At baseline and 12 months)
- Duration of previous treatments by indication(Up to 12 months)
- Type (anti-VEGF, laser, steroids, etc) of previous treatments by indication(Up to 12 months)
- Number of optical coherence tomography (OCT) assessments per patient(At 12 months)
- Number of visual acuity tests(At 12 months)
- Percentage of patients achieving a Snellen equivalent of 20/40 or better(At 12 months)
- Number of adjunctive therapies(At 12 months)
- Type of adjunctive therapies based on medical records or on interviewing the patient(At 12 months)
- Diabetic retinopathy severity (mild, moderate, severe)(At 12 months)
- Reason to switch to intravitreal aflibercept based on medical records or on interviewing the patient(At 12 months)
- Number of fundoscopy examinations(At 12 months)
- Number of visits outside the study center(At 12 months)