New trial into weight loss drugs use for treating ‘blinding’ headache condition

Patients with a debilitating condition causing headaches and potential sight loss, known as Idiopathic Intracranial Hypertension (IIH), are being sought to take part in new research in which they will receive weight loss drugs and have their eye health monitored at a high street optician.

Launched today, the IIH Advance trial, coordinated by academics at the University of Birmingham and delivered through the National Institute for Health and Care Research (NIHR) Birmingham Biomedical Research Centre, 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 predominantly affects women of childbearing age, with 90% of those living with it also experiencing obesity. IIH is currently considered a rare disease with most recent estimates suggesting that there are approximately 5,000 patients in the UK. Previous studies at the University of Birmingham 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.

“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.”

Professor Alex Sinclair, Chief Investigator of the trial

This latest trial will test whether using weight loss drugs will reduce symptoms of the condition. During the trial, participants will receive the weight loss drug Tirzepatide (marketed under the name Mounjaro) and will have Optical Coherence Tomography (OCT) eye scans at a participating Specsavers to monitor swelling of the optic nerves, called papilloedema, which is caused by intracranial pressure.

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 weight loss drug Mounjaro could have a significant positive impact for patients.”

“As GLP-1 medicines such as Mounjaro has 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.”

Close to home

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 nor any visits to the trial centre in Birmingham are required.

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 contacting 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, and Chief Investigator on the trial 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.”

Case study: Challenging diagnosis for education expert

Recently retired civil servant Elizabeth (Liz) Formby MBE has had, in her own words, “a wonderful journey through my life.” Liz has lived in four countries, committed herself to a career supporting education programmes, and was recognised in the Queen’s Birthday Honours in 2015.

However, Liz has also spent the past thirty years managing a diagnosis of Idiopathic Intracranial Hypertension (IHH). As Liz explains: “The diagnosis started to impact my life in my late thirties. At first, it was incredibly confusing. I felt something was not right at all but could not really explain it even to myself.”

“One weekend I drove to Wales to meet my brother and his family. It was the most dreadful journey I have ever made. I had to stop the car and was shaking, had a dreadful headache, and felt completely lost. I eventually made it to the cottage, and my family was shocked to see me shaking, sweating, and clearly not well. They put it down to me not being fit and overworking.

“I improved and put this moment behind me, but on returning to work, I realised I was struggling to see the screens in front of me and did not like the change of light as the screen changed. After another terrible car journey, I went to my local optician to speak to them. They carried out a field test and some other tests, then sent me directly to the hospital. I was kept in hospital as they initially thought I had a brain tumour, but I was diagnosed with IHH.”

Since her diagnosis, Liz has pursued an active and rewarding life – albeit with some activities she needs to avoid:

“I learnt to not put myself in a position where I felt unsafe with moving lights, or things moving around me. I could not cope with going into a cinema, or into a room that had lights moving around, like a disco. I could not cope with loud and sudden noises and lots of lights, so I stopped going to anything with fireworks, and to concerts and gigs. In a loud family setting with lots of people around, I would remove myself from the group and go and sit in a quieter area.”

Liz has been working with researchers at the University of Birmingham and University Hospitals Birmingham NHS Trust for years in an effort to find treatments for IIH following her personal experience. She said: “Anything that can help both inform and help reduce the debilitating outcome of having IIH will be so worthwhile for the person with it. It is also vital that those across the medical spectrum understand more about IIH and can recognise it, to get the help that is needed for the patient.

“Hopefully, with new research and knowledge gained from this trial, help can be given with dignity and more efficiently to those with IIH.”

IIH Advance is now open for participants to self-refer online.