Lee, Chan Ning
Desai, Riti
Ramazzotto, Lisa
Wafa, Hatem
Wang, Yanzhong
Bunce, Catey
Doungsong, Kodchawan
Ezeofor, Victory
Edwards, Rhiannon T.
Lois, Noemi
Steel, David H.
Peto, Tunde
Hillenkamp, Jost
van Meurs, Jan C.
Reeves, Barnaby C.
Jackson, Timothy L.
Funding for this research was provided by:
Fight for Sight UK (2036 / 2037)
Article History
Received: 11 December 2023
Accepted: 2 January 2025
First Online: 14 April 2025
Change Date: 5 May 2025
Change Type: Update
Change Details: For protocol v3.0 a version that included comments and tracked changes was originally published.
Declarations
:
: TIGER has obtained a favourable opinion from the Cambridge East Research Ethics Committee REC (20/EE/0293) and Health Research Authority (HRA) approval for protocol version 2.0 covering all sites in the UK on 17 January 2022 with full implementation across all sites on 18 January 2022. Protocol version 3.0 received HRA and Health Care Research Wales (HCRW) approval on 12 April 2023 with full implementation across all sites on 25 April 2023. Additional Institutional Review Board approvals will be sought to cover new sites as they join TIGER in continental Europe.
: A trial-specific patient informed consent form (ICF) will be used and has been previously described and included in the original protocol publication supplementary materials (1).
: None of the authors have any financial interest in any licensed TPA products. TJ’s employer receives site payments from Bayer and other commercial entities for participants enrolled on commercial clinical trials of aflibercept and other novel and licensed treatments for wet AMD, and he is a consultant to 2CTech, Alcon, Dutch Ophthalmic Research Centre, iLumen; Opthea, Outlook Therapeutics, Oxurion, Pfizer, and Regeneron and has received conference support from Roche. DS’s employer receives site payments from Bayer and other commercial entities for participants enrolled on commercial clinical trials of aflibercept and other novel and licensed treatments for wet AMD, and he is a consultant to Alcon, Gyroscope, DORC, BVI, Roche, Complement therapeutics, Alimera, and Eyepoint. CNL has undertaken contracting work for Opthea. RD and CNL’s employer has received payments for trials of novel and licensed treatments for wet AMD, including commercial trials of aflibercept. CB’s post is part funded by the National Institute for Health Research (NIHR) Biomedical Research Centre at The Royal Marsden NHS Foundation Trust and the Institute of Cancer Research, London; the views she expresses are her own and not necessarily those of the NIHR or the Department of Health and Social Care. JvM was on the Board of EUREINA when it commissioned Fight for Sight to run the call for funding but left the Board in 2019 before the grant was awarded and was not an applicant on the bid and has no other interests. VE, KD, RTE, LR, HW, YW, NL, TP, JH, and BCR have no competing interests.