Exudative Age-related Macular DegenerationNCT07004361
Ethical Issues of Using Gene Therapy in the Treatment of AMD
An observational study of Exudative Age-related Macular Degeneration, run by Nantes University Hospital at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Exudative Age-related Macular Degeneration
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jul 2025to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: exsudative AMD patients in o^pthalmology department in CHU Nantes
Who may be able to join
- Patients with exsudative AMD, male female >18 years Patients for whom the doctor could consider gene therapy.
Who cannot join
- Patients with atrophic AMD (Age-related Macular Degeneration) Patients with other degenerative retinal diseases than AMD, Patients with with associated cognitive disorders.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU Nantes - Ophthalmology Department
Nantes, Nantes, 44000
Alexandra Poinas, +33 2 40 08 33 33, alexandra.poinas@chu-nantes.fr
About this study
Official title: Ethical Issues of Using Gene Therapy in the Treatment of AMD (Age-related Macular Degeneration)
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
- Keywords
- ethical, Age-related Macular Degeneration
- Medical subject headings
- Macular Degeneration
What is being measured
The primary outcome is the main question the study is designed to answer.
The experience and current treatment outcomes perceived by patients
Semi-structured interviews
Measured: 1 months
Secondary outcomes (2)
Patients' perceptions, expectations, and potential concerns regarding gene therapy
Semi-structured interviews
Measured: 1 month
Patients' perception and representation of decisional autonomy in their health decisions
Semi-structured interviews
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2025
- Study start1 Jul 2025
- Primary completion1 Jul 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exudative Age-related Macular DegenerationStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07004361
- Sponsor's protocol ID
- AP_HM_001
- Status last verified
- Jun 2026
- First submitted
- 26 May 2025
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ethical Issues of Using Gene Therapy in the Treatment of AMD (Age-related Macular Degeneration)
- ClinicalTrials.gov ID
- NCT07004361
- Acronym / sponsor ID
- AP_HM_001
- Keywords
- ethical, Age-related Macular Degeneration
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 4 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- exsudative AMD patients in o^pthalmology department in CHU Nantes
Key inclusion criteria (1 listed)
- Patients with exsudative AMD, male female >18 years Patients for whom the doctor could consider gene therapy.
Key exclusion criteria (1 listed)
- Patients with atrophic AMD (Age-related Macular Degeneration) Patients with other degenerative retinal diseases than AMD, Patients with with associated cognitive disorders.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The experience and current treatment outcomes perceived by patients
Time frame: 1 months
Semi-structured interviews
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Exudative Age-related Macular Degeneration, run by Nantes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Helene Masse, M.D (+33 2 53 48 28 57, helene.masse@chu-nantes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The experience and current treatment outcomes perceived by patients (time frame: 1 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026.