Tag: clinical trial

Clinical trial provides new approach for people with eye disease to increase NHS capacity

A UK-wide study, led by Queen’s University Belfast, has shown how a new surveillance pathway for people with stable diabetic eye disease is safe and cost-saving, freeing up ophthalmologists to evaluate and treat people requiring urgent care. 

The new health care surveillance pathway may help ophthalmic units across the world to improve their capacity whilst saving patient’s sight. It is already having a positive impact on the re-design of NHS services across the UK, having been implemented successfully in several hospitals. 

The research, funded by the National Institute for Health Research (NIHR), has been published in leading journals including Ophthalmology, BMJ and NIHR’s Health Technology Assessment. 

The EMERALD (the Effectiveness of Multimodal imaging for the Evaluation of Retinal oedemA and new VesseLs in Diabetic retinopathy) diagnostic accuracy study tested a new “ophthalmic grader” pathway. Rather than ophthalmologists, this pathway involves trained graders monitoring people with previously treated and stable complications of diabetic eye disease, namely diabetic macular oedema (DMO) and proliferative diabetic retinopathy (PDR), based on the reading of images and scans of the back of their eyes.  

The grader’s pathway can save £1390 per 100 patients, and the real savings are the ophthalmologist’s time, which can then be redirected to the evaluation of people at high risk of visual loss. 

Professor Noemi Lois, lead researcher and Clinical Professor of Ophthalmology from the Wellcome-Wolfson Institute for Experimental Medicine at Queen’s University Belfast, explains: “Diabetic macular oedema and proliferative diabetic retinopathy, the main sight-threatening complications of diabetic retinopathy can cause blindness if left untreated. It is therefore important to diagnose them and to treat them timely.

“NHS hospitals eye units are under significant pressure given the extremely high number of people that need to be examined and treated and given the insufficient number of ophthalmologists in the UK. Currently, ophthalmologists need to evaluate all patients, even those that are stable after treatment and who are doing well.” 

In EMERALD, trained ophthalmic graders were found to achieve satisfactory results when compared to standard care (i.e., ophthalmologists evaluating patients in clinic) while releasing ophthalmologist’s time. 

Professor Lois added: “EMERALD showed trained ophthalmic graders are able to determine whether patients with diabetic macular oedema or proliferative diabetic retinopathy previously successfully treated remain stable or if on them the disease has reactivated.  

“Thus, they would be able to follow people that have been already treated, releasing ophthalmologists’ time. Ophthalmologists could then use this time to treat timely other patients, for example, those who have indeed diabetic macular oedema or active proliferative diabetic retinopathy and who have not yet received treatment saving their sight.” 

Dr Clare Bailey, consultant ophthalmologist at the Bristol Eye Hospital, said: “The important data from the EMERALD study has helped us to significantly increase the numbers of people with diabetic retinopathy being seen in ‘imaging/grading’ pathways.

“This has hugely increased our follow-up capacity, whilst allowing ophthalmologists’ time to be directed to the people with diabetic retinopathy who need treatment or further assessment. 

“This has helped us to deal with the capacity pressures as a result of Covid -19 as well as the longer-term capacity demands due to the increasing prevalence of diabetic retinopathy.” 

Dr Caroline Styles, Consultant Ophthalmologist with NHS Fife, added: “Emerald provided us in NHS Fife with the relevant evidence that allowed us to redesign our pathways for people with diabetic eye disease.

“The involvement of people with diabetes in this study reassures our population that these are safe and appropriate changes, and not just based on cost.” 

The EMERALD study was set in 13 National Health Service (NHS) hospitals across the UK and is a large multicentric, UK-wide, National Institute for Health Research (NIHR)-funded diagnostic accuracy study. 

New clinical trial launched for early treatment of COVID-19

A potential treatment for COVID-19, which has shown early promise in China and Japan, will be trialled in NHS Greater Glasgow and Clyde.

Glasgow is the first area in Scotland to have access to the drug, which can be taken at home when patients are in the early stages of disease as well as by hospitalised patients.

Over 300 eligible patients with COVID-19 will be invited to join the new research study into the effectiveness of the antiviral drug, favipiravir.

The trial will target early treatment of the virus for those who test positive and must be taken within four days of a COVID-19 swab test. This treatment is intended for people with milder symptoms.

The ground-breaking research is a collaboration between NHS Greater Glasgow and Clyde and the University of Glasgow, funded by the Chief Scientist Office of the Scottish Government. 

The study, Glasgow Early Treatment Arm Favipiravir (GETAFIX), will assess the effectiveness of the drug to help with symptoms and reduce the time it takes to recover from COVID-19.

Favipiravir has been developed by Fujifilm Toyama Chemicals in Japan and an early study on its effectiveness has shown it to alleviate some symptoms.

Three hospitals are taking part including Queen Elizabeth University Hospital, Glasgow Royal Infirmary and Royal Alexandra Hospital. Patients may receive treatment in hospital or as outpatients.

The antiviral treatment is taken in tablet form. Half the patients involved will receive the drug twice a day for 10 days alongside standard treatment, with the other half receiving standard treatment for comparison.

The study is organised by the Cancer Research UK Clinical Trials Unit in Glasgow and supported by the Glasgow Clinical Research Facility.

Prof Rob Jones, Director of the CRUK Clinical Trials Unit, Glasgow, and Chief Investigator of the study commented: “COVID-19 was a disease few of us had even heard of before the spring. Although hopes are high ongoing vaccine trials will help prevent infection, this trial aims to improve current treatment for those unlucky enough to contract it.

“With the GETAFIX trial, we will be rapidly looking at whether this antiviral treatment may help kill off the virus in those affected and prevent more serious complications.”

Dr Janet Scott (MRC-University of Glasgow Centre for Virus Research) said: “This drug is active against many viruses, it is used already for influenza in Japan. We are able to offer it not just to patients in hospital but also for home use.

“Our hope is that it will stop mild symptoms developing into serious ones. We are targeting volunteers who are at higher risk of progressing to serious COVID19 such as those over 60 years old or with underlying health problems.”

Patients sign up for COVID-19 clinical trial

Over 100 patients are taking part in a clinical trial for COVID-19 treatment at NHS Greater Glasgow and Clyde. 

Patients in Glasgow have started receiving potential treatment for COVID-19 as part of a clinical trial at NHS Greater Glasgow and Clyde, with 120 patients recruited so far. The RECOVERY clinical trial is one of the fastest growing trials looking at potential treatment of COVID-19.

NHS Greater Glasgow and Clyde anaesthetists, respiratory physicians, emergency medicine consultants, pharmacy teams and nurses are leading the board’s involvement in this UK-wide study, funded by the UK government.

The RECOVERY trial aims to find effective treatment for coronavirus patients by testing pre-existing medicine. This includes steroids, antivirals and antimalarial agents. Antibiotics may also be added at a future amendment.

The trial is adaptive in design so treatments that show promise will be used more frequently.

All patients with COVID-19 that are treated at Queen Elizabeth University Hospital, Glasgow Royal Infirmary, IRH and RAH will be offered to take part in the clinical trial. It is a randomised-controlled trial where patients are given an active drug or standard care.

This is part of NHS Greater Glasgow and Clyde’s efforts to move forward research and development related to COVID-19 as fast as possible.

Dr Jennifer Armstrong, Medical Director of NHS Greater Glasgow and Clyde, welcomed the move and said: “Our teams have been incredible in rising up to the challenge of COVID-19.

“Not just in the care and treatment of patients but also their dedication to improving our knowledge of the virus through clinical trials. This means our patients are receiving the most up to date treatment available.”

Professor Julie Brittenden, Research and Development Director, NHS Greater Glasgow and Clyde, said: “I want to thank all of our staff for their efforts during this incredibly challenging time.

“Our research, development and innovation teams are working hard to improve the diagnosis and treatment of COVID-19.

“We’ve been able to rapidly mobilise our teams to take part in clinical trials like RECOVERY and this is a testament to their dedication to the cause.”

Dr Kathryn Puxty, Intensive Care Consultant at Glasgow Royal Infirmary, said: “As we care for more and more patients with COVID-19, we are seeing first-hand the need for effective treatment.

“We will be asking patients with COVID-19 who we treat in hospital, if they want to be involved in this study in the hope that we can improve care as quickly as possible.”

Working with partners across UK, Scotland is leading, enabling and delivering world-class COVID-19 research as part of coordinated efforts to gather reliable evidence.

Facilitated through the Chief Scientist Office (CSO) of Scottish Government and NHS Research Scotland, a single, national prioritisation process for COVID-19 research draws on expert advice across the UK. This prioritises studies which hold the most potential, prevents duplication of effort and ensures the resources and capacity of the health care system are not exceeded.

Charles Weller, General Manager, NHS Research Scotland said: “RECOVERY has been the fastest growing clinical trial in medical history; and a crucial part of our efforts to better understand and tackle COVID-19. I want to thank all teams for their commitment and professionalism to this national priority study.”