Characterisation of RPGR-related IRD
Research type
Research Database
IRAS ID
351906
Contact name
Michel Michaelides
Contact email
Research summary
RGPR-related IRD in the UK: Moorfields Eye Hospital
REC name
East Midlands - Derby Research Ethics Committee
REC reference
25/EM/0003
Date of REC Opinion
4 Feb 2025
REC opinion
Further Information Favourable Opinion
Data collection arrangements
Clinical and imaging data from Moorfields Eye Hospital will be reviewed to locate and characterise all patients with RPGR-related IRD. A research dataset will be extracted from the Moorfields Eye Hospital electronic health/medical records for analysis, and pseudo-anonymised afterwards. Any patients who have opted out of having their data shared through the NHS England National Data Opt Out will be removed from the dataset and excluded from the study. The number of patients who have opted out in this way will be recorded.
A complete list of the variables which will be extracted is enclosed with this application. This list includes special category data, including ethnicity, genetic data, and data concerning a person's health. The dataset used in this study will be pseudonymised, where a log of any identifiable data will be kept separate from the database, this will act as a key, meaning individual patients’ data will be coded using a unique identifier in the database and they will not be directly identified. The funder, Johnson & Johnson, will not receive any patient-level data: they will only receive anonymised and aggregated analysed data in the form of a report produced by Moorfields Eye Hospital.
A separate dataset will also be created for patients with RPE65-related LCA, only including the number of patients. This is so the size of the following populations can be estimated:
RPE65-related LCA
RPGR-related rod-cone dystrophy
RPGR-related cone-rod dystrophy
RPGR-related cone dystrophy
RPGR-related sector RP
RPGR-related LCA
RPGR-related macular dystrophyThis data set will be processed in the same way. The data will be accessed by the direct care team and pseudonymised, and only the analysed, anonymised data will be shared with Johnson & Johnson.
Research programme
On 25th November 2024, Initiate Consultancy conducted a meeting on behalf of Moorfields Eye Hospital and J&J, with 5 UK participants with visual impairment related to RP (n=3), choroideremia (n=1), and Bardet-Biedl syndrome (n=1). These participants were identified independently by Retina UK, a charity. The patients were presented with an outline of the methodology of the study, and asked to provide their feedback, particularly with regards to how patient data will be managed and safeguarded. The meeting was chaired by Andrew Mumford, the CEO of Initiate Consultancy, who has experience in caregiving for a person with visual impairment. All materials were reviewed by representatives of Retina UK to ensure they were accessible for the visually impaired patient representatives. During the meeting itself, all slides were audibly dictated to ensure the material presented was accessible to all attendees, regardless of their level of visual impairment. There was overall agreement that the purpose of the study was clear, and that the approach presented in the protocol was appropriate. The panel agreed that they would be happy for Moorfields to use their data and/or that of other patients in the way outlined.
Research database title
RGPR-related IRD in the UK: Moorfields Eye Hospital
Establishment organisation
Moorfields Eye Hospital NHS Foundation Trust
Establishment organisation address
NIHR Moorfields Clinical Research Facility (CRF)
162 City Road
London
EC1V 2PD