Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

French prospective open label phase II randomized non-comparative study of SC tocilizumab associated with IV pulse steroid versus IV pulse steroid alone for the treatment of acute anterior ischemic optic neuropathy associated with giant cell arteritis. (TOCIAION)

This study is investigating a new treatment approach for a sudden and serious eye condition called acute anterior ischemic optic neuropathy (AION) which is linked to giant cell arteritis (GCA). GCA is a type of inflammation that affects blood vessels, including those supplying the eyes, potentially leading to vision loss. The research aims to see if adding a drug called tocilizumab (also known as RoActemra) to the standard steroid treatment can better improve vision compared to using steroids alone. Participants will receive either standard steroid treatment or steroids plus tocilizumab. The main goal is to measure improvements in vision after eight weeks, specifically if eyesight gets better by a certain amount.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Centre Hospitalier National D'Ophtalmologie Quinze-Vingts

Enrolment target

Start

27 Jan 2025

Acute Anterior Ischemic Optic Neuropathy associated with Giant Cell Arteritis in Horton's Disease

What is this study about?

This research study is about a serious eye problem called acute anterior ischemic optic neuropathy (AION), which can cause sudden vision loss. This problem often happens in people who have a condition called giant cell arteritis (GCA). GCA is an illness where blood vessels become inflamed, and if this happens in the blood vessels that go to your eye, it can harm your vision quickly.

The study wants to understand if a new medicine can help people with this eye condition better than the usual treatment. Currently, the main treatment involves strong steroid medications, often given into a vein. This study is testing if adding a drug called tocilizumab (also known as RoActemra), which is given as an injection under the skin, along with the steroids, can lead to more significant improvements in eyesight. They will compare how well people's vision improves after eight weeks.

While the main focus is on vision improvement, the researchers will also check many other things. This includes whether vision stays stable, if there are changes in how well patients can see their whole visual field, and how the blood vessels in the eye look. They will also monitor how well other symptoms of GCA respond to treatment, look at blood tests related to inflammation, and see if the new drug helps prevent the eye condition or GCA from coming back. The study will also carefully track any side effects to make sure the treatments are safe.

Key takeaways

This study investigates a new treatment for sudden vision loss linked to giant cell arteritis.
It compares standard steroid treatment with steroids plus a drug called tocilizumab.
The main goal is to see if combination treatment improves vision more effectively.
Researchers will also monitor prevention of recurrence and overall safety.
Participation involves regular eye checks, blood tests, and medical appointments.
It's important to discuss all aspects with doctors before deciding to participate.

Who may be eligible?

To join this study, people must be at least 18 years old. Both men and women can take part.

More specific details about your current health, medical history, and other medications you might be taking would need to be checked by the study doctors to confirm if this study is right for you. This is to ensure the study is safe for you and that the results they get are clear and reliable.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have acute anterior ischemic optic neuropathy (AION) linked to giant cell arteritis (GCA)?
Have you discussed this study with your doctor?
Are you able to attend regular hospital or clinic appointments for several months?

Answer every question to see your result.

What does participation involve?

Taking part in this study would involve receiving either the standard steroid treatment (given into a vein) or the standard steroids plus the new drug tocilizumab (given as an injection under the skin). You would have regular appointments over several weeks to check your vision using special eye charts (like ETDRS charts), and possibly other eye tests like visual field tests. Doctors will also check your blood to track inflammation and your general health. The study would involve several visits to the hospital or clinic, particularly in the first few weeks, to monitor your response to treatment and check for any side effects. The total duration of active participation and follow-up would likely extend for at least 13 weeks (about 3 months).

Potential risks and benefits

Potential benefits could include an improved chance of recovering some lost vision due to the new treatment combination. You would also receive close medical attention and monitoring for your condition. However, there are potential risks, as with any medication, including possible side effects from the steroids or tocilizumab. These could range from mild to serious and would be fully explained by the study team. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
France

Common questions

What is giant cell arteritis (GCA)?

GCA is a condition where the blood vessels, especially those in the head, become inflamed. This can sometimes affect the blood supply to the eyes and other parts of the body.

What is acute anterior ischemic optic neuropathy (AION)?

AION is a sudden and serious eye condition that can cause vision loss. It happens when the blood supply to the optic nerve (which connects your eye to your brain) is disrupted.

What is tocilizumab (RoActemra)?

Tocilizumab is a medicine that helps reduce inflammation in the body. It is already used for some other inflammatory conditions.

How will my vision be checked?

Your vision will be checked using special eye charts (like the ETDRS chart) and possibly other tests that look at your field of vision and the blood vessels in your eye.

Will I know which treatment I am receiving?

This is an 'open label' study, which means both you and your study doctors will know which treatment you are receiving (either steroids alone or steroids with tocilizumab).