Ophthalmology specialty profile
Why you should deliver ophthalmology research in the UK
Ophthalmology is one of 30 specialties within the National Institute for Health Research (NIHR) Clinical Research Network (CRN) which brings together communities of clinical practice to provide national networks of research expertise. Our membership is made up of research-active clinicians and practitioners drawn from national and local levels, who ensure that our NIHR CRN Portfolio of studies are appropriately supported and successfully delivered.
Since 2015, an average of over 14,300 participants were recruited into Ophthalmology Specialty research studies per year. We constitute a cohesive group with established clinical research centres throughout the UK and internationally renowned opinion leaders amongst our midst. The NIHR Ophthalmology Specialty Group is composed of ophthalmologists and optometrists and co-opted members of eyecare charities. Our members represent each of the 15 Local Clinical Research Networks that cover England in addition to nominated leads for Wales, Scotland and Northern Ireland. The group also have academic links, international links and an industry strategy. We cover the full range of subspecialties within ophthalmology with internationally recognised strengths in the areas of retina, glaucoma, uveitis and genetics. Our portfolio covers academic and industry sponsored studies as well as MedTech research. Since 2017/18 we have had a dedicated Trials Manager to coordinate with overseas sponsors of large international multicentre studies in facilitating set up with networks of UK hospital sites. The support we provide includes:
A high proportion of our membership is comprised of nationally and internationally recognised key opinion leaders, many of whom are Principal Investigators for studies and have acted as Chief Investigators. We also have a national Industry Lead for commercial studies (25 per cent of our studies in 2018/19) who provides strategic direction. The UK leads in ophthalmology research, delivering Phase 1 to Phase 4 studies. Fast set up has helped our researchers deliver a number of global, rest of world and European first recruitments in commercial studies.
We hold training workshops and symposia to improve knowledge of CRN activities in the UK workforce, and many of our regional leads conduct ‘NIHR Roadshows’ in their regions. We also collaborate closely with the following non-governmental organisations: Macula Society, RNIB, Fight for Sight; and professional organisations: Royal College of Ophthalmologists (RCOphth) and The College of Optometrists. In doing so we support NIHR research delivery in the UK through Research Awards, Trainee Research Networks, and Masterclasses.
We have several extremely successful networks in the fields of Retina and Glaucoma with UK wide studies ongoing. We have established a network of Principal Investigators with the knowledge, resources and infrastructure to permit participation in early phase studies. Additionally, we have established a national network of ophthalmic reading centres and we have established links with key Contract Research Organisations.
We have implemented a symposium at the Annual RCOphth Congress with the specific role of engagement and portfolio development with industry sponsors.
The Ophthalmology Specialty Group has dedicated webpages accessible via the ‘Research Hub’ of the RCOphth website.
Access to patients
Ophthalmology has been at the forefront in instituting Electronic Medical Records systems for data collection and this has facilitated the identification of eligible patient populations. We have established links with patient organisations that provide access to difficult to reach patient groups. Working with optometrist colleagues in the community we are able to recruit participants from both primary and secondary care settings.
We have access to a large pool of potential participants - in 2018/19, there were over 7.8 million NHS Ophthalmology hospital outpatient attendances and nearly 2 million of these attendances were for first consultations. As a consequence, participation in NIHR CRN Ophthalmology studies is very high: in 2018/19, 80 of 111 hospitals with acute eye care services in England (72 per cent) were recruiting into at least one NIHR portfolio ophthalmology study.
Performance of Ophthalmology studies
The Ophthalmology Specialty Group supports the delivery of our studies to time and target. We actively manage study performance through direct involvement of the National Specialty Lead, specific members of the specialty group and the NIHR CRN Industry team. The Ophthalmology Specialty recruited over 9,400 participants into 164 studies in 2018/19. Of these 164 studies, 62 were new studies supported by the NIHR CRN (26 commercial and 36 non-commercial).
We facilitate discussions with sponsors, providing early feedback and suggesting strategies for site selection and improved recruitment. We also contribute to the national study support services including early feedback, site intelligence and site identification.
Over the last six years the Ophthalmology Specialty has achieved seven first global and six first European participants.
LEAVO: comparing the clinical and cost effectiveness of intravitreal therapy with ranibizumab (Lucentis) vs aflibercept (Eylea) vs bevacizumab (Avastin) for Macular Oedema due to Central Retinal Vein Occlusion
This study is the largest interventional study by site to date on the Ophthalmology Specialty portfolio, recruiting 463 participants at 44 sites across England, Wales, Scotland and Northern Ireland over two years. Sponsored by Moorfields Eye Hospital, the study results will play a key role in determining the delivery of patient care for macular oedema due to central retinal vein occlusion in the UK over the next five to ten years.
SOMNUS: effect of ocular disease on sleep and circadian rhythm
This multi-centre study has been active for over seven years and successfully met its initial recruitment target of 3,200 in 2018. Funded by a Wellcome grant, this is the first study to collect both qualitative and quantitative data on the impact of eye diseases on sleep and circadian rhythms in collaboration with 11 sites across the Thames Valley, South coast, London and Wales. Without funding from the CRN this study would not have recruited so effectively.
STAR: retinal gene therapy for Choroideremia
An international, phase 3 clinical study of the choroideremia gene therapy, sponsored by Nightstar Therapeutics, was launched in early 2018 and the first participants have been enrolled and treated at the Oxford Eye Hospital. This study follows on from the successful phase 1 study launched there in early 2017: a first-in-man clinical trial of a gene therapy for X-linked retinitis pigmentosa. Support from the CRN has been important in successfully delivering these studies with both exceeding their UK recruitment targets.
United Kingdom Inherited Retinal Degeneration Consortium
This UK consortium was established with funding from the Retinal Action (formerly UK RP-Fighting Blindness) and Fight for Sight to find new genes in inherited retinal degeneration, solve difficult cases, create a working partnership between the main centres working in inherited retinal degeneration; and to create a database to encourage the sharing of data among other aims. It has led to a number of novel gene discoveries, 21 publications so far, and development of significant combined bioinformatic expertise, and further collaborations internationally.
The four centres: Leeds, Manchester, Moorfields, and Oxford, were recently joined by four other centres including Southampton, Bristol, Cardiff and Glasgow. This UK wide project is a real example of the power of working collaboratively.