Ethical Issues of Using Gene Therapy in the Treatment of AMD

NCT07004361 | Recruiting

• 1 other identifier: AP_HM_001
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Exudative Age-related Macular Degeneration

Keywords

ethical; Age-related Macular Degeneration

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

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (1)

CHU Nantes - Ophthalmology Department

Nantes, Nantes, 44000, France

RECRUITING

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Central Study Contacts

Helene Masse, M.D

CONTACT

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

Alexandra Poinas, PhD

CONTACT

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

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: July 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 24, 2026

Record last verified: 2026-06

Locations

FR (1)