- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04648124
VIsual Cerebral ConnecTivity On Functional Magnetic Resonance Imaging in Patients With Hereditary REtinal Dystrophies (VICTOIRE)
July 10, 2023 updated by: Fondation Ophtalmologique Adolphe de Rothschild
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 Overview
Status
Recruiting
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
200
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: amélie YAVCHITZ
- Phone Number: 0148036454
- Email: ayavchitz@for.paris
Study Locations
-
-
-
Paris, France, 75019
- Recruiting
- Fondation Adolphe de Rothschild
-
Contact:
- Augustin Lecler, PhD
- Email: alecler@for.paris
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Patients with hereditary retinal dystrophies whether or not to undergo implantation surgery
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
case
|
Functional MRI of functional brain networks
|
Patients for whom there is no planned implant surgery
|
Functional MRI of functional brain networks
|
Patients for whom implantation surgery is planned
|
Functional MRI of functional brain networks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Localization and characterization of neural networks
Time Frame: baseline
|
neuronal networks description using rest and morphological functionnal MRIs
|
baseline
|
Evolution of neuronal networks after retinal implantation
Time Frame: baseline
|
neuronal networks description using rest and morphological functionnal MRIs
|
baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Augustin LECLER, Fondation Ophtalmologique A. de Rothschild
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 4, 2021
Primary Completion (Estimated)
January 1, 2024
Study Completion (Estimated)
July 1, 2026
Study Registration Dates
First Submitted
August 26, 2020
First Submitted That Met QC Criteria
November 27, 2020
First Posted (Actual)
December 1, 2020
Study Record Updates
Last Update Posted (Actual)
July 11, 2023
Last Update Submitted That Met QC Criteria
July 10, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ALR_2020_30
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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