Fibrosis study

• Research type

  Research Study

• Full title

  Fibrosis study

• IRAS ID

  353476

• Contact name

  Tunde Peto

• Contact email

  t.peto@qub.ac.uk

• Sponsor organisation

  Queen's University Belfast

• Clinicaltrials.gov Identifier

  632522, Contract number

• Duration of Study in the UK

  2 years, 0 months, 1 days

• Research summary

  Among the global population with moderate or severe vision impairment, age-related macular degeneration (AMD) is ranked the third cause of vision loss after refractive error and cataract (PMID: 29032195). The projected number of people with AMD in 2020 is 196 million, increasing to 288 million in 2040 (PMID: 25104651). AMD comes in two main forms, the neovascular form (nAMD) and the atrophic form. nAMD responds well to anti-VEGF treatment but unfortunately development of atrophy and/or fibrosis -which result in vision loss- is a common outcome from treatment (PMID: 26445075; PMID: 25542520). To date it is unclear whether the atrophy and fibrosis are solely the consequences of the degenerative process of AMD itself or if exacerbated by exposure to anti-VEGF. Our projects aim to fill this gap by identifying biomarkers in treatment naïve nAMD patients who develop complete RPE and outer retinal atrophy and or fibrosis over time after treatment onset. Appropriately anonymised study data is polled and being graded for re-analyses from a cohort study and real-world sources of BHSCT with multiple time-points. Appropriate permissions are in place to make sure no data with patient identifiable information is transferred and that the data was collected with the appropriate ethical approvals and donor consent.
  Multimodal real-world data from NUH will be added to the already existing data repository of Fibrosis after the required ethical approval is in place. The real-world data from NUH will be appropriately anonymised at donor sites before data transfer to the recipient site. None of the collected information will allow re-identification of study participants and keys will remain at the donor study sites.
  

• REC name

  North of Scotland Research Ethics Committee 1

• REC reference

  25/NS/0026

• Date of REC Opinion

  7 Mar 2025

• REC opinion

  Favourable Opinion