Ethical Issues of Using Gene Therapy in the Treatment of AMD (Age-related Macular Degeneration)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- The experience and current treatment outcomes perceived by patients
研究概览
简要总结
The objective of this study is to examine the legitimacy of gene therapy use in the treatment of exudative age-related macular degeneration (AMD). This involves questioning its beneficence/non-maleficence ratio given the limited experience with this innovative technology and its irreversible effects, requiring a surgical procedure for administration. Additionally, the study explores patient autonomy in decision-making concerning complex therapeutic approaches and how patients should be supported to best uphold this autonomy.
详细描述
Qualitative research based on semi-structured interviews conducted with patients diagnosed with age-related macular degeneration (AMD), followed in the ophthalmology department of Nantes University Hospital and treated with intravitreal injections. These interviews are structured around three main themes in order to better understand:
The experience and perception of the current treatment by the patients
Their perceptions, expectations, and potential concerns regarding gene therapy
Their perception and understanding of decision-making autonomy in their health decisions
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- •Patients with exsudative AMD, male female >18 years Patients for whom the doctor could consider gene therapy.
排除标准
- •Patients with atrophic AMD (Age-related Macular Degeneration) Patients with other degenerative retinal diseases than AMD, Patients with with associated cognitive disorders.
结局指标
主要结局
The experience and current treatment outcomes perceived by patients
时间窗: 1 months
Semi-structured interviews
次要结局
- Patients' perceptions, expectations, and potential concerns regarding gene therapy(1 month)
- Patients' perception and representation of decisional autonomy in their health decisions(1 month)