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NCT Number: NCT07004361

Ethical Issues of Using Gene Therapy in the Treatment of AMD

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.

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Key information

Conditions

Exudative Age-Related Macular Degeneration Eye Diseases Macular Degeneration Retinal Degeneration Retinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. The experience and current treatment outcomes perceived by patients

    Time frame: 1 months

    Semi-structured interviews

Secondary outcomes

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

    Time frame: 1 month

    Semi-structured interviews

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

    Time frame: 1 month

    Semi-structured interviews

Study contacts

Contact information is provided by the study sponsor or research team.

Alexandra Poinas, PhD

CONTACT

[email protected]

+33 2 53 48 28 57

Helene Masse, M.D

CONTACT

[email protected]

+33 2 53 48 28 57

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Official study title

Ethical Issues of Using Gene Therapy in the Treatment of AMD (Age-related Macular Degeneration)

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 4, 2025
Registry last updated
Jun 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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