Vision Functional Brain Networks in Patients With Hereditary Retinal DystrophiesVICTOIRENCT04648124
VIsual Cerebral ConnecTivity On Functional Magnetic Resonance Imaging in Patients With Hereditary REtinal Dystrophies
An observational study of Vision Functional Brain Networks in Patients With Hereditary Retinal Dystrophies, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
Trial summary
The Rothschild Foundation A Hospital follows a cohort of approximately 300 patients with hereditary retinal dystrophy. These patients are followed in ophthalmology consultation every year. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vision Functional Brain Networks in Patients With Hereditary Retinal Dystrophies
- What is being tested?
- IRMf-r (séquence resting state)
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 4 Jan 2021to Jul 2028
- 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: Patients with hereditary retinal dystrophies whether or not to undergo implantation surgery
Who may be able to join
- Patient over 18 years old
- Diagnostic clinique de dystrophie rétinienne héréditaire ou maculopathie héréditaire, syndromique ou non syndromique
- Artificial vision treatment such as a retinal implant, or optogenetics scheduled in the next 6 months
- Express consent to participate in the study
- Affiliate or beneficiary of a social security scheme
Who cannot join
- Patient benefiting from a legal protection measure
- Pregnant or breastfeeding woman
- Contraindication to MRI (claustrophobia, implanted equipment such as pacemaker).
- Other additional ocular pathology that can significantly affect vision
- Recent eye surgery less than 3 months old
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
Fondation Adolphe de Rothschild
Paris, PARIS, 75019
Augustin Lecler, PhD, alecler@for.paris
About this study
The Rothschild Foundation A Hospital follows a cohort of approximately 300 patients with hereditary retinal dystrophy. These patients are followed in ophthalmology consultation every year. In order to plan the MRI on the day of the annual consultation and to avoid additional travel for patients, patients will be informed of the study before the consultation (transmission of an information letter and the information note from study). If patients agree to participate in the study, rMRI will be scheduled. During the follow-up ophthalmologic consultation, after checking the inclusion and non-inclusion criteria, the study information will be repeated, and patients who still agree to participate will sign the study consent.
- Being tested
- IRMf-r (séquence resting state)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IRMf-r (séquence resting state)Device
Functional MRI of functional brain networks
| Study group | Role | What they receive |
|---|---|---|
| Patients for whom there is no planned implant surgery | Not described Receives: Device: IRMf-r (séquence resting state) | |
| Patients for whom implantation surgery is planned | Not described Receives: Device: IRMf-r (séquence resting state) | |
| case | Not described Receives: Device: IRMf-r (séquence resting state) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Localization and characterization of neural networks
neuronal networks description using rest and morphological functionnal MRIs
Measured: baseline
Evolution of neuronal networks after retinal implantation
neuronal networks description using rest and morphological functionnal MRIs
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2020
- Study start4 Jan 2021
- Primary completionJan 2026 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vision Functional Brain Networks in Patients With Hereditary Retinal DystrophiesStudies of the same condition, open and under way.
- More trials run by Fondation Ophtalmologique Adolphe de RothschildThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Augustin LECLER, Principal investigator, Fondation Ophtalmologique A. de Rothschild
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04648124
- Sponsor's protocol ID
- ALR_2020_30
- Acronym
- VICTOIRE
- Status last verified
- Dec 2025
- First submitted
- 26 Aug 2020
- Last updated
- 5 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VIsual Cerebral ConnecTivity On Functional Magnetic Resonance Imaging in Patients With Hereditary REtinal Dystrophies
- ClinicalTrials.gov ID
- NCT04648124
- Acronym / sponsor ID
- VICTOIRE / ALR_2020_30
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- 4 Jan 2021 (actual)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 1 Dec 2020 (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 Rothschild Foundation A Hospital follows a cohort of approximately 300 patients with hereditary retinal dystrophy. These patients are followed in ophthalmology consultation every year. In order to plan the MRI on the day of the annual consultation and to avoid additional travel for patients, patients will be informed of the study before the consultation (transmission of an information letter and the information note from study). If patients agree to participate in the study, rMRI will be scheduled. During the follow-up ophthalmologic consultation, after checking the inclusion and non-inclusion criteria, the study information will be repeated, and patients who still agree to participate will sign the study consent.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients for whom there is no planned implant surgery | – | Device: IRMf-r (séquence resting state) |
| Patients for whom implantation surgery is planned | – | Device: IRMf-r (séquence resting state) |
| case | – | Device: IRMf-r (séquence resting state) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with hereditary retinal dystrophies whether or not to undergo implantation surgery
Key inclusion criteria (5 listed)
- Patient over 18 years old
- Diagnostic clinique de dystrophie rétinienne héréditaire ou maculopathie héréditaire, syndromique ou non syndromique
- Artificial vision treatment such as a retinal implant, or optogenetics scheduled in the next 6 months
- Express consent to participate in the study
- Affiliate or beneficiary of a social security scheme
Key exclusion criteria (5 listed)
- Patient benefiting from a legal protection measure
- Pregnant or breastfeeding woman
- Contraindication to MRI (claustrophobia, implanted equipment such as pacemaker).
- Other additional ocular pathology that can significantly affect vision
- Recent eye surgery less than 3 months old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IRMf-r (séquence resting state)Functional MRI of functional brain networks | Device | Patients for whom implantation surgery is planned, Patients for whom there is no planned implant surgery, case |
Primary outcome
Localization and characterization of neural networks
Time frame: baseline
neuronal networks description using rest and morphological functionnal MRIs
Evolution of neuronal networks after retinal implantation
Time frame: baseline
neuronal networks description using rest and morphological functionnal MRIs
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 5 Jan 2026.
- Individual participant dataSharing planned: No
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.
Augustin LECLER principal investigator
Fondation Ophtalmologique A. de Rothschild
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 Vision Functional Brain Networks in Patients With Hereditary Retinal Dystrophies, run by Fondation Ophtalmologique Adolphe de Rothschild 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 5 inclusion and 5 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 5 Jan 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 Amélie YAVCHITZ (0148036454, ayavchitz@for.paris), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Localization and characterization of neural networks (time frame: baseline). The study lists 2 primary outcomes in all. 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 5 Jan 2026.