Questions and Answers

Gevokizumab is a new investigational drug being developed in patients with uveitis (it is not yet approved in the UK or other countries).

It is a type of drug called a ‘monoclonal antibody’. It blocks a protein called interleukin-1 beta (IL-1β), hence it is an anti-IL-β monoclonal antibody.

IL-1β is thought to play a role in the inflammation occurring in the eye in patients with uveitis. By blocking IL-1β, gevokizumab may help to reduce the inflammation and improve symptoms.

There is a need to find new drugs for the treatment of uveitis. To find out if gevokizumab has a role in the treatment of uveitis, it needs to be tested under controlled conditions i.e. in a clinical trial.

Two trials that are investigating the safety and effectiveness of gevokizumab are taking place, EYEGUARD A and EYEGUARD C. Please find details below.

In EYEGUARD A, the A stands for Active.

This trial is investigating whether gevokizumab can help to resolve the symptoms of active uveitis i.e. a flare of uveitis. This trial also continues to closely monitor the safety of gevokizumab.

In EYEGUARD C, the C stands for Controlled.

This trial is investigating whether gevokizumab helps to prevent further flares of uveitis. As for the Eyeguard A study this trial also continues to assess the safety of gevokizumab.

These trials are for adults aged 18 or older who have been diagnosed with non-infectious uveitis.

Not all patients will be eligible. Each trial has a list of specific criteria that the study team need to check to see if you are suitable to take part.

For example in EYEGUARD A patients need to be experiencing a flare of their uveitis and need to be taking steroids and an immunosuppressant drug.

If you decide to contact the study team they will ask some key questions about the history of your uveitis and your current treatments. This will be a first step to understanding if you may be suitable for one of these trials.

A total of 300 patients are needed for each trial, which are being conducted across Europe, America and in other countries around the world.

NO.

In both EYEGUARD A and EYEGUARD C there is a 2 in 3 chance of receiving gevokizumab and a 1 in 3 chance of receiving placebo. Which treatment a patient receives is decided randomly by computer.

A placebo is a dummy drug.  It contains no active ingredients.

Two different doses of gevokizumab are being investigated in these trials, 30mg and 60mg.

There is a 1 in 3 chance of receiving 30mg of gevokizumab, a 1 in 3 chance of receiving 60mg of gevokizumab and a 1 in 3 chance of receiving placebo.

NO.

These studies are known as “double-blind” trials, which means that neither you nor the study team will know whether you are receiving gevokizumab or placebo, although your doctor can find out if s/he needs to.

Like all drugs gevokizumab may cause side effects.

To date, more than 1,000 patients have received gevokizumab in trials, and its safety profile is being closely monitored across all trials.

If you have any further questions, the study team would be happy to discuss with you in detail all available data.

Both gevokizumab and placebo will be given by an injection in the abdomen (tummy) once a month. The injection will be given by the study team.

YES, except steroids.

In both studies steroids will slowly be reduced.

The trials started in the UK in September 2014.

Both EYEGUARD A and EYEGUARD C last for a minimum of 12 months and a maximum of 15 months.

The duration depends on your symptoms of uveitis and whether or not there is a response to the study drug.

• Moorfields Eye Hospital
• Bristol Eye Hospital

More hospitals are being added.

Both studies involve monthly visits to the study team for a minimum of 12 months and maximum of 15 months. An important consideration for these studies is the need to attend monthly study visits.

If this is feasible for you, please contact the study teams directly via the website link below to discuss these trials further.

Olivia’s Vision (OV) is a charity which was founded to support uveitis patients and their families.

OV was asked by Servier to help inform patients about the EYEGUARD A and C trials.

OV is an independent charity, which can therefore give impartial and confidential advice. Everyone affected by uveitis, children and adults, is free to use our Forum and Helpline.

• The study team will invite you to the hospital to discuss the trial in detail.
• You will be given a patient information sheet that describes what the trial would involve e.g. what tests would be done and when.
• You will have the opportunity to ask questions.
• You will have some routine tests to see if you qualify for one of the trials.
• If all is OK you will be asked to attend a screening visit for either the EYEGUARD A or EYEGUARD C trial.

• If you have not done so already you will be asked to sign a consent form for the trial.
• You will have a full physical and eye exam.
• You will be asked about your medical history.
• Your blood pressure, pulse, temperature, height and weight will be noted.
• An ECG (trace of your heart) and a chest X-ray will be done.
• Various blood tests will be done.
• A urine sample will be taken.

• You will be asked to visit the hospital monthly for trial visits.
• Your general health will be assessed and the study team will check the treatments you are taking.
• Your blood pressure, temperature and weight will be measured.
• At nearly all visits you will have detailed eye tests.
• At some visits further blood tests will be done.
• An ECG will be done every 6 months
• A chest X-ray will be repeated at the end of the study.
• You will complete some questionnaires that ask about quality of life (EYEGUARD A only).

You would contact the study team immediately.

They will assess your uveitis and if needed will start treatment with high doses of steroids. If high doses of steroids are successful there is a possibility that you will become eligible to receive gevokizumab 60mg.

You should seek medical advice as normal e.g. via your GP and you should also inform a member of the study team as soon as possible.

If it is a problem with your eyes you should contact the study team immediately.

You would be free to withdraw from the trial at ANY time.

It is perfectly normal to have second thoughts. You would need to talk about your concerns with the study team, your GP or consultant.

Patients who have completed the EYEGUARD A and C studies may be eligible for a long-term study assessing the safety of gevokizumab.

You would contact your study doctor if there are any problems at all.

You will be given a card with details of the study, and emergency contact numbers which you will be asked to carry with you at all times.

Should you have to visit a different doctor tell them that you are taking part in a trial and that the study doctor should be contacted.

NO.

However, travel expenses, refreshments, and other reasonable expenses for all trial related visits will be reimbursed for you and any person who may accompany you (e.g. family member or carer), upon production of receipts.

The companies developing gevokizumab have organised these trials. The companies are called Xoma and Servier.

These studies are also supported by the NHS National Institute for Health Research (NIHR).