Please watch our animation

This video is intended to provide an overview of the trial for general awareness. It is not intended for patient recruitment at present.

Participant Information Animation

IIH increases pressure inside the brain causing severe headaches and vision problems.

Research shows that for people with increased body weight, losing weight helps relieve symptoms of IIH.

The IIH-Advance Trial will see if a weight-loss drug called Tirzepatide, could help adults with IIH and papilloedema, living with obesity, to lose weight.

If you agree to take part you’ll be asked to provide a doctor’s letter confirming your diagnosis. The letter might be available on your NHS app.

You will be asked to sign a consent form.

You will then have an eye scan at a local Specsavers to check that you still have sufficient papilloedema.

The trial has three stages, each lasting about six months.

Not everyone will complete all three stages.

If you do not receive the weight loss drug for the first six months and your papilloedema improves, you will not enter the second stage.

Everyone else will receive the weight loss drug for at least six months.

The medication will be delivered to your home and you will take it weekly using an injector pen.

We will send you some scales to monitor your weight.

Plus a kit to provide samples of your blood, saliva, urine and stool at the start and at 3 and 6 months.

Each month, you’ll have a video meeting to check on your health and weight, to make sure you can continue in the trial.

Everyone, even those not on the drug, must attend these monthly video visits.

If you miss appointments, you may not receive the drug, or be given the drug in the future.

Every six months, you’ll have an eye scan to check if your papilloedema has responded to treatment.

In stage one you will be randomly chosen to either take Tirzepatide or continue with your usual NHS care.

After six months if you were prescribed Tirzepatide and have responded well, you will be randomly selected to stay on the drug or come off the drug.

If you come off the drug, you will continue with your usual NHS care for 6 months and then you will be offered Tirzepatide for a further final six months.

If you were on Tirzepatide and your papilloedema didn’t respond after six months, you will leave the trial.

If you were allocated the usual NHS care initially and your papilloedema is still present at six months you will be randomly chosen to either take Tirezepatide or continue with your usual NHS care.

If you have been on standard NHS care for twelve months, you will be offered Tirzepatide for the final six months.

Taking part is voluntary, and you can leave the trial at any time without giving a reason.

We will cover your travel costs to the eye scan appointments at your local Specsavers.

There may be some side effects of taking Tirzepatide but it is already widely used within the NHS.

By taking part you will help us to improve the longer-term care for people with IIH.

If you would like to join the study, please complete the contact form.

Background

Idiopathic Intracranial Hypertension (IIH) is a condition characterised by elevated intracranial pressure. It occurs most often in women of childbearing age with obesity.

The elevated brain pressure drives papilloedema with ensuing chronic disabling headaches and risk of visual loss (which can be severe and permanent). There is no licenced medication for IIH; management of IIH is consequently challenging.