Ethical Issues of Using Gene Therapy in the Treatment of AMD
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Exudative Age-related Macular Degeneration. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Ethical Issues of Using Gene Therapy in the Treatment of AMD (Age-related Macular Degeneration)
Overview
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
Primary outcome measures
- The experience and current treatment outcomes perceived by patients [Time frame: 1 months]
Secondary outcome measures (2)
- Patients' perceptions, expectations, and potential concerns regarding gene therapy [Time frame: 1 month]
- Patients' perception and representation of decisional autonomy in their health decisions [Time frame: 1 month]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
France · 1 center
- CHU Nantes - Ophthalmology Department — Nantes
Identifiers
NCT: NCT07004361 · AP_HM_001