Ethical Issues of Using Gene Therapy in the Treatment of AMD

Not yet recruiting

• Conditions: Exudative Age-related Macular Degeneration

• Registration Number: NCT07004361
• Lead Sponsor: Nantes University Hospital

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

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-26
• Study First Submitted QC: 2025-05-26
• Last Update Submitted: 2025-05-26
• Study First Posted: 2025-06-04
• Last Update Posted: 2025-06-04
• Study Start: 2025-07-01
• Primary Completion: 2026-07-01
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Patients with exsudative AMD, male female >18 years Patients for whom the doctor could consider gene therapy.

Exclusion Criteria

Patients with atrophic AMD (Age-related Macular Degeneration) Patients with other degenerative retinal diseases than AMD, Patients with with associated cognitive disorders.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The experience and current treatment outcomes perceived by patients	1 months	Semi-structured interviews

Secondary Outcome Measures

Name	Time	Method
Patients' perceptions, expectations, and potential concerns regarding gene therapy	1 month	Semi-structured interviews
Patients' perception and representation of decisional autonomy in their health decisions	1 month	Semi-structured interviews