Ethical Issues of Using Gene Therapy in the Treatment of AMD
1 other identifier
observational
30
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jul 2025
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 26, 2025
CompletedFirst Posted
Study publicly available on registry
June 4, 2025
CompletedStudy Start
First participant enrolled
July 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
June 4, 2025
May 1, 2025
1 year
May 26, 2025
May 26, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The experience and current treatment outcomes perceived by patients
Semi-structured interviews
1 months
Secondary Outcomes (2)
Patients' perceptions, expectations, and potential concerns regarding gene therapy
1 month
Patients' perception and representation of decisional autonomy in their health decisions
1 month
Eligibility Criteria
exsudative AMD patients in o\^pthalmology department in CHU Nantes
You may qualify if:
- Patients with exsudative AMD, male female \>18 years Patients for whom the doctor could consider gene therapy.
You may not qualify if:
- Patients with atrophic AMD (Age-related Macular Degeneration) Patients with other degenerative retinal diseases than AMD, Patients with with associated cognitive disorders.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 26, 2025
First Posted
June 4, 2025
Study Start
July 1, 2025
Primary Completion (Estimated)
July 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
June 4, 2025
Record last verified: 2025-05