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. 2022 Jan 31;23:99. doi: 10.1186/s13063-021-05966-3
Title {1} Vitrectomy, subretinal Tissue plasminogen activator and Intravitreal Gas for submacular haemorrhage secondary to Exudative Age-Related macular degeneration (TIGER): a phase 3, pan-European, two-group, non-commercial, active-control, observer-masked, superiority, randomised controlled surgical trial.
Trial registration {2a and 2b}.

Clinical.Trials.gov identifier: NCT04663750, registered 11th December 2020; EudraCT identifier: 2020-004917-10, registered 12th October 2020.

All items from the World Health Organisation (WHO) Trial Registration Dataset are available as a supplementary appendix (Appendix 12).

Protocol version {3} Version 1.3, 19th January 2021
Funding {4} EURETINA sought to facilitate a study of vitrectomy, TPA and gas for submacular haemorrhage secondary to neovascular AMD. It commissioned Fight for Sight to establish a pan-European competition seeking bids to run the study, and to administer the award. King’s College London was awarded the research grant from Fight for Sight. To help facilitate set-up prior to the main grant commencing, EURETINA provided King’s College London a smaller start-up research grant. Different prospective sites were known to use different intravitreal drugs to treat wet AMD, and therefore Bayer was approached and agreed to provide and distribute free aflibercept to sites that required it, to standardise background treatment. In the UK, sites are additionally supported by the National Institute for Health Research (NIHR) through its Clinical Research Network. A copy of the funding letter of support is included in Appendix 10.

Author details {5a}

(Names and Affiliations of Protocol Contributors)

Professor Timothy L. Jackson, Faculty of Life Sciences and Medicine, King’s College London, London, UK

Dr Catey Bunce, The Royal Marsden NHS Foundation Trust, London and Surrey UK

Mrs Riti Desai, Department of Ophthalmology, King’s College Hospital NHS Foundation Trust, London, UK

Professor Jost Hillenkamp, Department of Ophthalmology, University of Wurzburg, Wurzburg, Germany

Dr Chan Ning Lee, Department of Ophthalmology, King’s College Hospital NHS Foundation Trust, London, UK

Professor Noemi Lois, Wellcome-Wolfson Institute for Experimental Medicine, Queen’s University, Belfast, Northern Ireland

Professor Tunde Peto, Network of Ophthalmic Reading Centres UK, Queen’s University of Belfast, Belfast, Northern Ireland

Professor Barnaby C. Reeves, University of Bristol, Bristol, UK

Professor David H. Steel, Bioscience Institute, Newcastle University, Newcastle, UK

Professor Rhiannon T. Edwards, Centre for Health Economics and Medicines Evaluation, Bangor University, Bangor, Wales

Dr Hatem Wafa, Population Health Sciences, Faculty of Life Sciences and Medicine, King’s College London, London, UK

Dr Yanzhong Wang, Population Health Sciences, Faculty of Life Sciences and Medicine, King’s College London, London, UK

Name and contact information for the trial sponsor {5b} Professor Timothy L. Jackson, Department of Ophthalmology, King’s College Hospital, London SE5 9RS, UK
Role of sponsor {5c} The Sponsor was responsible for the study design. Fight for Sight ran the competition for funding, and as part of the review process its anonymised experts provided feedback on trial design that was incorporated into the final design. EURETINA’s brief to Fight for Sight defined the two groups to be compared (surgery and anti-VEGF therapy versus anti-VEGF monotherapy). The study team (employed by the Sponsor) will be responsible for the collection, management, analysis, and interpretation of data; writing of this and subsequent reports; and the decision to submit all reports for publication. Bayer has no input into any of the design, execution or reporting of the trial, other than provision of free Eylea® to sites that request it.