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RecruitingNCT07004361Updated Jun 24, 2026

Ethical Issues of Using Gene Therapy in the Treatment of AMD

An observational study in Exudative Age-related Macular Degeneration, sponsored by Nantes University Hospital. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-24.

Sponsored by Nantes University Hospital · Observational

From the registry’s dates

  • Primary completion was expected by Jul 2026, 3 months ago, but the record still lists the study as recruiting.
  • Started Jul 2025; still recruiting 1 year 3 months later.
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
30
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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

02

Conditions studied

  • Exudative Age-related Macular Degeneration

Keywords

  • ethical
  • Age-related Macular Degeneration
03

In context

Macular Degeneration

1,474 studies on the registry are indexed under Macular Degeneration; 206 are open to participants now.

This study's planned enrollment of 30 is below the median of 106 across 421 observational studies indexed under Macular Degeneration.

Browse Macular Degeneration studies →

Lead sponsor

Nantes University Hospital is the lead sponsor of 825 studies on the registry; 195 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

exsudative AMD patients in o\^pthalmology department in CHU Nantes

Inclusion criteria

  • Patients with exsudative AMD, male female >18 years Patients for whom the doctor could consider gene therapy.

Exclusion criteria

Exclusion Criteria:

Patients with atrophic AMD (Age-related Macular Degeneration) Patients with other degenerative retinal diseases than AMD, Patients with with associated cognitive disorders.

05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
30 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. The experience and current treatment outcomes perceived by patients

    Semi-structured interviews

    Time frame: 1 months

Secondary outcomes

  1. Patients' perceptions, expectations, and potential concerns regarding gene therapy

    Semi-structured interviews

    Time frame: 1 month

  2. Patients' perception and representation of decisional autonomy in their health decisions

    Semi-structured interviews

    Time frame: 1 month

07

Study locations

1 of 1 sites recruiting
  • CHU Nantes - Ophthalmology Department
    Nantes, Nantes 44000, France
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07004361
Lead sponsor
Nantes University Hospital
Responsible party
Sponsor
First posted
Jun 4, 2025
Start date
Jul 1, 2025
Primary completion
Jul 1, 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
Jun 24, 2026

Study contacts

Helene Masse, M.D
Contact
helene.masse@chu-nantes.fr
+33 2 53 48 28 57
Alexandra Poinas, PhD
Contact
alexandra.poinas@chu-nantes.fr
+33 2 53 48 28 57

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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