The authors would like to thank the following for their invaluable help:
Essential support and guidance was provided by the KCTU, the service user group, the TSC (chairperson Alistair Laidlaw) and the DMEC (chairperson Sarah Walker). We would also like to thank the Royal Free London NHS Foundation Trust Pharmacists and members of the independent UK Network of Ophthalmic Reading Centres (NetwORC UK) for their support of the trial. We would like to thank the lay panel in the North East Diabetes Research Network and Mr Richard Lane OBE (Officer of the Most Excellent Order of the British Empire), lay representative grant co-applicant.
We would also like to express thanks to the NIHR Local Clinical Research Networks.
Finally, and most importantly, we would like to thank all the patients who took part in the study and the follow-up survey.
Support
The study was sponsored by NIHR Moorfields Biomedical Research Centre and supported by the UK Clinical Research Network. The research was supported by the NIHR Biomedical Research Centre at Moorfields Eye Hospital NHS Foundation Trust and University College London Institute of Ophthalmology, the NIHR Moorfields Clinical Research Facility and the UK Clinical Research Collaboration-registered KCTU at King’s Health Partners, which is part funded by the NIHR Biomedical Research Centre for Mental Health at South London and Maudsley NHS Foundation Trust and King’s College London. We would also like to thank Maggie Shergill, the Research Manager (Monitoring) and the other team members of the NIHR Evaluation Trials and Studies Coordinating Centre (NETSCC).
Contributions of authors
All authors reviewed, revised and approved the final version of the manuscript.
Sobha Sivaprasad (Professor, Consultant Ophthalmologist) was the chief investigator and co-authored the first draft.
Philip Hykin (Consultant Ophthalmic Surgeon) was a co-applicant, was involved in the design and recruitment of the study and co-authored the first draft.
A Toby Prevost (Professor, Medical Statistics) was a co-applicant, was involved in the design and statistical analysis of the study and co-authored the first draft.
Joana Vasconcelos (Research Fellow, Medical Statistics) was involved in the design and statistical analysis of the study and co-authored the first draft.
Amy Riddell (Trial Manager) was involved in all aspects of the study’s management and monitoring and co-authored the first draft.
Jayashree Ramu (Research Fellow, Moorfields Eye Hospital) was involved in the design and recruitment of the study and co-authored the first draft.
Caroline Murphy (King’s Clinical Trial Unit) was a co-applicant and was involved in the design and trial management and co-authored the first draft.
Joanna Kelly (King’s Clinical Trial Unit) was a co-applicant, was involved in the design and data management and co-authored the first draft.
Rhiannon Tudor Edwards (Professor, Health Economics) was a co-applicant and was involved in the design, management, analysis and interpretation of the health economics part of the study, the co-authoring of the first draft and the writing up of the report.
Seow Tien Yeo (Research Fellow, Health Economics) was involved in the management, analysis and interpretation of the health economics part of the study, the co-authoring of the first draft and the writing up of the report.
James Bainbridge (Professor, Consultant Ophthalmic Surgeon) was a co-applicant and was involved in the design of the study.
David Hopkins (Diabetologist) was a co-applicant and was involved in the design of the study.
Beverley White-Alao (King’s Clinical Trial Unit) was involved in the protocol development and study management and co-authored the first draft.
Publications
Sivaprasad S, Prevost AT, Bainbridge J, Edwards RT, Hopkins D, Kelly J, et al. Clinical efficacy and mechanistic evaluation of aflibercept for proliferative diabetic retinopathy (acronym CLARITY): a multicentre phase IIb randomised active-controlled clinical trial. BMJ Open 2015;5:e008405.
Sivaprasad S, Prevost AT, Vasconcelos JC, Riddell A, Murphy C, Kelly J, et al. Clinical efficacy of intravitreal aflibercept versus panretinal photocoagulation for best corrected visual acuity in patients with proliferative diabetic retinopathy at 52 weeks (CLARITY): a multicentre, single-blinded, randomised, controlled, phase 2b, non-inferiority trial. Lancet 2017;389:2193–203.
Nicholson L, Crosby-Nwaobi R, Vasconcelos JC, Prevost AT, Ramu J, Riddell A, et al. Mechanistic evaluation of panretinal photocoagulation versus aflibercept in proliferative diabetic retinopathy: CLARITY substudy. Invest Ophthalmol Vis Sci 2018;59:4277–84.
Data-sharing statement
Data are archived at Moorfields Eye Hospital. All data requests should be submitted to the corresponding author for consideration. Access to anonymised data may be granted following review.
Patient data
This work uses data provided by patients and collected by the NHS as part of their care and support. Using patient data is vital to improve health and care for everyone. There is huge potential to make better use of information from people’s patient records, to understand more about disease, develop new treatments, monitor safety, and plan NHS services. Patient data should be kept safe and secure, to protect everyone’s privacy, and it’s important that there are safeguards to make sure that it is stored and used responsibly. Everyone should be able to find out about how patient data are used. #datasaveslifes You can find out more about the background to this citation here: https://understandingpatientdata.org.uk/data-citation.
Disclaimers
This report presents independent research. The views and opinions expressed by authors in this publication are those of the authors and do not necessarily reflect those of the NHS, the NIHR, the MRC, NETSCC, the EME programme or the Department of Health and Social Care. If there are verbatim quotations included in this publication the views and opinions expressed by the interviewees are those of the interviewees and do not necessarily reflect those of the authors, those of the NHS, the NIHR, NETSCC, the EME programme or the Department of Health and Social Care.