Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not recruiting

Study on the Effectiveness of Tocilizumab, Methylprednisolone, and Prednisone for Patients with Acute Anterior Ischemic Optic Neuropathy in Giant Cell Arteritis

Verified siteRegistered drugNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the treatment of Acute Anterior Ischemic Optic Neuropathy associated with Giant Cell Arteritis, also known as Horton's Disease. The study aims to determine if a medication called tocilizumab, given as a subcutaneous injection, can improve eye health when used alongside traditional steroid treatments. The steroids used in this study include methylprednisolone hemisuccinate, administered intravenously, and prednisone, taken orally.

The purpose of the study is to see if adding tocilizumab to the usual steroid treatment can lead to better outcomes for patients with this eye condition. Participants will receive four injections of tocilizumab over one month, with each injection given every seven days. The study will compare the effects of this combination treatment to the effects of steroids alone. The main goal is to observe any improvements in vision after eight weeks of treatment.

Throughout the study, researchers will monitor various aspects of eye health, including changes in vision and the condition of the blood vessels in the eye. They will also look at the overall health of patients with Giant Cell Arteritis and track any side effects or adverse events. The study will help determine if tocilizumab can be a beneficial addition to the treatment plan for this condition.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial treatment phase

    The treatment begins with the administration of tocilizumab through a subcutaneous injection. This is done once a week for four weeks. The medication is provided as RoActemra 162 mg solution in a pre-filled syringe.

    Alongside tocilizumab, methylprednisolone hemisuccinate is administered intravenously. This is a high-dose steroid treatment given as SOLUMEDROL 1 g, in powder form mixed with a solvent for injection.

  2. Step 2

    Oral medication phase

    After the initial treatment phase, prednisone is taken orally. This medication is provided as PREDNISONE VIATRIS 20 mg tablets. The dosage and duration are determined by the healthcare provider based on individual response and condition.

  3. Step 3

    Monitoring and evaluation

    Vision improvement is assessed at week 8. The primary goal is an increase of at least two lines of visual acuity on the ETDRS chart.

    Secondary evaluations occur at weeks 4, 8, and 13. These include stabilization of vision, changes in visual field measurements, and improvements in other symptoms of Giant Cell Arteritis (GCA).

    Additional assessments involve changes in eye imaging and biological markers, as well as monitoring for any adverse effects.

  4. Step 4

    Follow-up and safety assessment

    The influence of the one-month tocilizumab treatment on the recurrence of acute anterior ischemic optic neuropathy (AION) and GCA is evaluated at week 13.

    Safety is continuously assessed through the monitoring of adverse events and serious adverse events throughout the trial.

Who can join the trial?

4 criteria

  • Must have a diagnosis of GCA (Giant Cell Arteritis). This is a condition where the blood vessels, especially those in the head, become inflamed.
  • Must have AION (Acute Anterior Ischemic Optic Neuropathy). This is a sudden and painless loss of vision, with swelling of the optic disc, that has occurred within the last week.
  • Must be 50 years of age or older.
  • Must have social insurance.

Who cannot join the trial?

5 criteria

  • Patients who have a different eye condition not related to **Acute Anterior Ischemic Optic Neuropathy**. This is a sudden loss of vision due to reduced blood flow to the optic nerve.
  • Patients who do not have **Giant Cell Arteritis**. This is a condition where blood vessels, usually in the head, become inflamed.
  • Patients who are not within the specified age range for the study.
  • Patients who are part of a vulnerable population, which means they might need special protection or care.
  • Patients who cannot receive the study treatment, which includes **tocilizumab** injections and a conventional steroid regimen. **Tocilizumab** is a medication that helps reduce inflammation.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

  • Tocilizumab

    is a medication used in this study to see if it can help improve eye health in patients with a specific type of eye problem called acute anterior ischemic optic neuropathy, which is related to a condition known as giant cell arteritis. In this trial, tocilizumab is given as an injection under the skin once a week for four weeks. It is being tested to see if it works better when used together with standard steroid treatment.

  • Intravenous Pulse Steroid

    is a treatment that involves giving high doses of steroids directly into the bloodstream. This method is used to quickly reduce inflammation and is a common treatment for conditions like giant cell arteritis, which can cause serious eye problems. In this study, the steroid treatment is being used alone and in combination with tocilizumab to see which approach is more effective in improving eye health.

What is already known about the treatment

Tocilizumab – Tocilizumab is administered as a subcutaneous injection, typically given once a week. It is currently being studied in clinical trials for its potential to improve outcomes in patients with acute anterior ischemic optic neuropathy associated with giant cell arteritis, a condition also known as Horton's disease. The medication works by inhibiting the interleukin-6 (IL-6) receptor, which plays a role in the inflammatory process. Tocilizumab is classified as an immunosuppressive agent and is being evaluated for its effectiveness in reducing inflammation and preventing further damage to the optic nerve in this specific condition.

Investigated diseases

Acute Anterior Ischemic Optic Neuropathy associated with Giant Cell Arteritis – This condition involves sudden vision loss due to reduced blood flow to the optic nerve, often linked with inflammation of the arteries in Giant Cell Arteritis. The optic nerve, responsible for transmitting visual information from the eye to the brain, becomes damaged due to insufficient blood supply. Symptoms typically include sudden, painless vision loss in one eye, which may progress to the other eye if untreated. Giant Cell Arteritis, also known as Horton's Disease, is characterized by inflammation of the large and medium-sized arteries, often affecting the arteries in the head. This inflammation can lead to symptoms such as headaches, jaw pain, and scalp tenderness. The progression of the disease can result in further complications if the inflammation is not controlled.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-519977-20-00Protocol codeP17-03Estimated enrolment58 patientsSponsorCentre Hospitalier National D'Ophtalmologie Quinze-Vingts

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.