Ignite Creation Date:
2025-12-24 @ 12:02 PM
Ignite Modification Date:
2026-03-27 @ 10:57 PM
Study NCT ID:
NCT07004361
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-06-04
First Post:
2025-05-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ethical Issues of Using Gene Therapy in the Treatment of AMD
Sponsor:
Nantes University Hospital
Organization:
Study Overview
Official Title:
Ethical Issues of Using Gene Therapy in the Treatment of AMD (Age-related Macular Degeneration)
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: