NCT01771081已完成不适用
POLARIS: A Non-interventional Study in Patients With Diabetic Macular Edema (DME) With Central Involvement to Assess the Effectiveness of Existing Anti-vascular Endothelial Growth Factor (Anti-VEGF) Treatment Regimens
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
- 911
- 主要终点
- Changes in visual acuity, assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) or SNELLEN
研究概览
简要总结
POLARIS : A non-interventional study in patients with diabetic macular edema (DME) with central involvement to assess the effectiveness of existing anti-vascular endothelial growth factor (anti-VEGF) treatment regimens.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with type 1 or 2 diabetes mellitus
- •Patients diagnosed with DME with central involvement (defined as the area of the center subfield of optical coherence tomography [OCT])
- •Patients for whom the decision has been made to treat with an approved anti-VEGF therapy prior to inclusion into the study
- •Patients who received the first approved intravitreal anti VEGF treatment from October 01, 2012
- •Patients who give informed consent in writing for study participation
排除标准
- •Treatment with any anti-VEGF therapy prior to the start of the observation period (October 01, 2012) or enrolment into the study
- •Participation in an investigational program with interventions out of clinical routine practice
研究组 & 干预措施
Group1
干预措施: Ranibizumab (or other DME treatment) (Drug)
结局指标
主要结局
Changes in visual acuity, assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) or SNELLEN
时间窗: Baseline, after 12 months
次要结局
- Resource utilization in terms of treatment choices, frequency and duration(Baseline, after 6 and 12 months)
- Mean change in quality of life score (using the NEI VFQ 25), only in countries where used as part of routine practice(Baseline, after 6 and 12 months)
- Demographic and clinical characteristics (Age, sex, race, employment status, severity of DME)(Baseline)
- Mean time from diagnosis to first commencement with an approved anti-VEGF therapy(Date of first diagnosis; Date of treatment initiation: up to 24 month)
- Changes in retinal thickness, measured by Optical Coherence Tomography (OCT)(Baseline, after 12 month)
- Presence of clinically significant macular edema, measured as defined by the ETDRS Research Group(Baseline, after each month, up to 12 month)
研究者
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