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

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07004361

Enrollment

Registered

2025-06-04

Start date

2025-07-01

Completion date

2026-12-01

Last updated

2026-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Exudative Age-related Macular Degeneration

Keywords

ethical, Age-related Macular Degeneration

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

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
The experience and current treatment outcomes perceived by patients	1 months	Semi-structured interviews

Secondary

Measure	Time frame	Description
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

Countries

France

Contacts

CONTACTHelene Masse, M.D

helene.masse@chu-nantes.fr+33 2 53 48 28 57

CONTACTAlexandra Poinas, PhD

alexandra.poinas@chu-nantes.fr+33 2 53 48 28 57

Outcome results