Ethical Issues of Using Gene Therapy in the Treatment of AMD

Nantes University Hospital (NUH)

Status: Not yet enrolling

Conditions: Exudative Age-related Macular Degeneration

Study type: Observational

Funder types: Other

Identifiers

NCT07004361

AP_HM_001

Details and patient eligibility

About

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.

Full 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

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.