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NCT05122442: EPI-genRET

Multicenter, Non-interventional Study, Describing Patients With Inherited Retinal Disease (IRD) in France

Completed Results posted Last updated 27 January 2026
What this trial tests

trial testing Patients with inherited retinal disease in Inherited Retinal Disease in 998 participants. Completed in 1 December 2023.

Timeline
30 November 2021
Primary endpoint
1 December 2023
1 December 2023

Quick facts

Lead sponsorUniversity Hospital, Strasbourg, France
StatusCompleted
Study typeOBSERVATIONAL
Enrollment998
Start date30 November 2021
Primary completion1 December 2023
Estimated completion1 December 2023
Sites1 location across France

Drugs / interventions tested

Conditions studied

Sponsor

University Hospital, Strasbourg, France

Who can join

6 and older, any sex, with Inherited Retinal Disease. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Proportion of Patients by Type of IRD Primary · 12 month

To describe the genetic testing characteristics To describe the distribution of variant of uncertain significance (VUS - class 3 variants) in IRD-associated genes To describe the proportion of unsolved patients To describe the type of pathogenic variants in each IRD-associated gene identified

Isolated progressive inherited retinal disorders
GroupValue95% CI
Patients With Inherited Retinal Disease720
Syndromic inherited retinal disorders
GroupValue95% CI
Patients With Inherited Retinal Disease174
Isolated stationary inherited retinal disorders
GroupValue95% CI
Patients With Inherited Retinal Disease30
Other
GroupValue95% CI
Patients With Inherited Retinal Disease58

Sponsor's own description

Genetic diagnostic testing becomes increasingly important for enhancing our understanding of the disease notably the genetics and providing the best care to the patients, and several initiatives seek to gather more data in order to better understand and treat those diseases. Within this context, Novartis and SENSGENE/Strasbourg University Hospitals (HUS) want to set up, through a research collaboration, a non-interventional study in France to better understand the epidemiology of IRDs, particularly the distribution of pathogenic variants in patients. This study aims to serve as a starter study to implement an IRD national registry led by SENSGENE/Strasbourg University Hospitals (HUS). The data collected might also be used to populate global European registries. The primary objective has been defined in a sufficient broad way to address this perspective of registries. As IRDs can present from birth to late middle age, this study will include both children and adult patients regardless of age, sex, and the type of IRD.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Other University Hospital, Strasbourg, France trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05122442.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing