Non-Persistence/Non-Adherence of German wAMD Patients Related to Their Anti-VEGF Injections: Extent, Explanations and Patients' Preferences
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 480
- 主要终点
- Non-Persistence (NP) in the wAMD therapy in alternative study-specific definitions: (1) no eye exam for a period of at least 3 months OR (2) no 2 subsequent Anti-VEGF injections despite a clear medical need for injections
研究概览
简要总结
In the research study an observation of patients with wet age-related macular degeneration (wet AMD) will be performed.
The term observational study indicates that the current course of therapy and the associated circumstances will be recorded. In this study, no medical care is changed. Also, no new drugs are tested.
This study is being conducted in about 30 centers in Germany. A total of approximately 500 patients will be enrolled. The study is designed for a period of 12 months.
At the beginning and end of the study the physician will document the patient data. Therefore will be used information from the patient records and documented visits. If such information is not available in the study center, the otherwise attending ophthalmologist will be consulted about the vision acuity values and visits in the observation period.
Furthermore, patients are asked to participate in three telephone interviews and fill out during their visits to the study center a short questionnaire about their current vision and their well-being. In the telephone interviews will be discussed with the patient about his wet AMD disease and its treatment, its experience and its perspectives as well as any problems occur.
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
- •Patient has wet age-related macular degeneration (wAMD)
- •Patient has already received at least one Anti-VEGF injection
- •From a clinical standpoint, if there is an ophthalmological need for treatment it is probable that the patient gets additional anti-VEGF injections in the next year.
- •The patient is able and willing to take part in the study (answering a short questionnaire in the study centre, 4 independent phone interviews during study period).
排除标准
- •At time of inclusion visit, the study centre is only exceptionally responsible for the treatment of the patient.
- •The patient is taking part in another study.
研究组 & 干预措施
Group 1
干预措施: Anti-VEGF injections (Drug)
结局指标
主要结局
Non-Persistence (NP) in the wAMD therapy in alternative study-specific definitions: (1) no eye exam for a period of at least 3 months OR (2) no 2 subsequent Anti-VEGF injections despite a clear medical need for injections
时间窗: 12 months after a patient was included into the study
次要结局
- Identifying patients' preferences (based on patients' questionnaires) towards treatment and treatment schemes(Measurement during patient interview after about 11 months after inclusion)
- Extent of Non-Adherence (NA) in the Anti-VEGF-therapy in a study-specific definition: (1) no eye exam every 4th week OR (2) no Anti-VEGF injection despite a medical need for an injection(12 months after inclusion of patients)
- Identifying NA/NP outcomes (assessed by visual acuity)(Every eye doctors visit between inclusion of patients and their exclusion)
- Identifying NA/NP causes (multivariate analysis based on patient interviews; main factors are sociodemographics and patient preferences)(Measurement during patient interviews about 4/8 months after inclusion)