A Prospective Observational Study Conducted in France to Describe Routine Clinical Practice for Treatment naïve or Previously Treated Patients With Diabetic Macular Edema (DME) Who Are Starting IVT Aflibercept
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 402
- 主要终点
- Mean change in Best Corrected Visual Acuity from baseline to month 12 in treatment naïve patients and previously treated patients
研究概览
简要总结
The main objectives of this observational study were to describe outcomes, monitoring and treatment patterns of patients with diabetic macular edema in routine clinical practice who are either treatment naïve patients or previously treated patients. The total study population was evaluated as well as the two subgroups (previously treated patients and treatment naïve patients).
This study was designated to answer French Health Authority (HAS Haute Autorité de Santé) requirements.
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
- •Man or woman aged 18 years or older
- •Patient diagnosed with a visual impairment due to diabetic macular disease (as defined by HAS (Haute Autorité de Santé) recommendation).
- •Patients in whom a decision to treat with intravitreal aflibercept has been made independently of the patient enrollment in the study
- •Patient diagnosed with type 1 or 2 diabetes mellitus
- •Patient who has been given appropriate information about the study and who has given his/her written, informed consent
排除标准
- •Patient with other retinal disease at the time of inclusion
- •Patients currently being treated with intravitreal aflibercept. This study will only include patients new to intravitreal aflibercept
- •Systemic use of any anti / pro VEGF therapy (VEGF: Vascular Endothelial Growth Factor)
- •Patient taking part in an interventional study
研究组 & 干预措施
Previously treated patient
Already treated with any other treatment such as an anti-VEGF agent (other than IVT aflibercept), macular laser photocoagulation (laser), intravitreal steroid injection or implant (steroids) and initiating treatment with IVT aflibercept
干预措施: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321) (Drug)
Naïve patient
Not previously treated with an anti-VEGF agent, macular laser photocoagulation (laser) or intravitreal steroid injection or implant (steroids) and initiating treatment with IVT aflibercept
干预措施: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321) (Drug)
Entire study population
Already treated patient with any other treatment such as an anti-VEGF agent (other than intravitreal aflibercept), macular laser photocoagulation, intravitreal steroid injection and initiating treatment with intravitreal aflibercept and not previously treated patients with an anti-VEGF agent, macular laser photocoagulation or intravitreal steroids injection and initiating treatment with intravitreal aflibercept
干预措施: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321) (Drug)
结局指标
主要结局
Mean change in Best Corrected Visual Acuity from baseline to month 12 in treatment naïve patients and previously treated patients
时间窗: At baseline and 12 months
次要结局
- Mean change in Best Corrected Visual Acuity between baseline and 12-month follow-up for the entire study population(At baseline and 12 months)
- Reason for starting intravitreal aflibercept(At baseline, 12 months and 24 months)
- Proportion of patients with change in fluorescein angiograph outcomes between baseline and 24-month follow-up for all groups(At baseline and 24 months)
- Proportion of patients with change in fundus photography outcomes between baseline and 24-month follow-up for all groups(At baseline and 24 months)
- Proportion of patients with no fluid determined by optical coherence tomography (OCT) between baseline and 24-month follow-up(At baseline, 12 months and 24 months)
- Date of the last administered treatment in previously treated patients(At baseline)
- Number of eyes injected(Up to 24 months)
- Number of visits with injection(Up to 24 months)
- Mean change in blood pressure during macular disease monitoring(At baseline, 12 months and 24 months)
- Duration of the disease (DME Monitoring)(At baseline)
- Number of participants with ocular and non-ocular safety events(Up to 24 months)
- Number of monitoring visits for diabetes (by diabetologists, general practitioners) outside the study center over 12 and 24 months (if known by the ophthalmologist) (DME monitoring)(Up to 24 months)
- Mean change in Best Corrected Visual Acuity between baseline and 24-month follow-up for all groups(At baseline and 24 months)
- Mean change in Central Retinal Thickness between baseline and 12-month follow-up for all groups(At baseline and 12 months)
- Mean change in Central Retinal Thickness between baseline visit and 24-month follow-up for all groups(At baseline and 24 months)
- Type of the previous treatment(s) in previously treated patients(At baseline)
- Duration (months) of the previous treatment in previously treated patients(At baseline)
- Interval (days) between injections(Up to 24 months)
- Type of adjunctive therapy post IVT aflibercept initiation(Up to 24 months)
- Mean change in HbA1c level during macular disease monitoring(At baseline, 12 months and 24 months)
- Number of visits for monitoring only (DME Monitoring)(Up to 24 months)
- Number of visits with OCT assessments (DME monitoring)(Up to 24 months)
- Number of visits with fluorescein angiography assessments (DME monitoring)(Up to 24 months)
- Number of visits with visual acuity measurements (DME monitoring)(Up to 24 months)
- Number of visits for injection only (DME Monitoring)(Up to 24 months)
- Number of visits combining monitoring and injection (DME Monitoring)(Up to 24 months)
- Number of visits with fundus photography assessments (DME monitoring)(Up to 24 months)