NCT07004361

Ethical Issues of Using Gene Therapy in the Treatment of AMD

Ethical Issues of Using Gene Therapy in the Treatment of AMD (Age-related Macular Degeneration)

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 30 (estimated)
• Sponsor: Nantes University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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

Conditions

• Exudative Age-related Macular Degeneration

Timeline

• Start date: 2025-07-01
• Primary completion: 2026-07-01
• Completion: 2026-12-01
• First posted: 2025-06-04
• Last updated: 2025-06-04