Trial to investigate weight loss drugs for treating blinding headache condition
Patients with Idiopathic Intracranial Hypertension (IIH), which causes headaches and potential sight loss, are being invited to take part in new research investigating the impact of weight loss drugs on their condition and eye health.
The IIH Advance trial, coordinated by clinical academics at BHP founder-member the University of Birmingham, aims to recruit 86 people with IIH from around the UK to take part in the trial lasting over a year, which will be delivered in partnership with Specsavers.
IIH is currently considered a rare disease with, affecting approximately 5,000 patients in the UK. It predominantly affects women of childbearing age, and 90% of those living with it also experience obesity. Previous studies at the University have established a direct link between IIH, metabolic dysregulation and obesity, so researchers anticipate that IIH prevalence is set to increase significantly as obesity levels continue to rise.
During the trial, participants will receive the weight loss drug Tirzepatide (commonly known as Mounjaro) and will have Optical Coherence Tomography (OCT) eye scans at a participating branches of Specsavers to monitor swelling of the optic nerves, called papilloedema, which is caused by intracranial pressure.
The study is delivered through the National Institute for Health and Care Research (NIHR) Birmingham Biomedical Research Centre (BRC).
Dr Maria Lange from the University of Birmingham and co-investigator on the trial said: “IIH is a debilitating condition, and after years of research to better understand the condition, this innovative trial will see whether weight loss, achieved by using the drug Mounjaro could have a significant positive impact for patients.”
“As GLP-1 medicines such as Mounjaro have become available for weight management through the NHS, we hope that the IIH Advance trial will establish a link between losing weight using these drugs and reducing the symptoms of IIH.”
Welcoming the trial, Specsavers’ director of professional advancement Paul Morris said: “IIH is a serious condition that can lead to blindness, and the role that community optometrists and their skilled teams can play in harnessing technology to detect serious eye conditions is pivotal. That’s why regular sight tests are so important. We welcome this innovative trial and are looking forward to collaborating with participants in it as well as the team at the University of Birmingham.”
People with a diagnosis of IIH who have papilloedema and live in the UK will be eligible to take part and are invited to self-nominate themselves to the trial. No doctor’s referral is required, and patients will not need to visit hospital or the trial centre in Birmingham.
Each participant will receive regular deliveries of Mounjaro to their home and will have regular calls with a research team member. They will also undergo eye scans at a participating Specsavers practice at the start of the trial, at six and 12 months, and at the conclusion of the trial.
Dr Jessie Gew, from the University of Birmingham and co-investigator adds: “IIH patients can now directly contact the trial team to self-refer. Once contact is made, our team will work closely with each participant to review relevant medical documentation and confirm eligibility for the study.”
Professor Alex Sinclair, Consultant Neurologist and Professor of Neurology at University of Birmingham, who leads the Idiopathic Intracranial Hypertension Clinical Service at University Hospitals Birmingham NHS Foundation Trust, said : “This trial is an example of the type of pioneering research that could ease pressure on the NHS through innovative community-focused collaboration with industry. We believe that this vision for a trial that streamlines care and empowers patients to participate and receive treatment from the comfort of their own homes is exactly the type of research that the NHS 10-year plan is calling for.”
IIH Advance is now open for participants to self-refer online.