Frontlight ResearchEarly access
CompletedPhase 2
Efficacy of tocilizumab in the treatment of acute anterior ischemic optic neuropathy optic neuropathy in Horton's disease
Key facts
- Who runs it
- Centre Hospitalier National D'Ophtalmologie Quinze-Vingts
- Where
- France10 sites in 1 countryChoose a country to see its sites
- Status
- Completed
- Phase
- Phase 2
- People taking part
- 58 people enrolled
- Started
- 27 Jan 2025
- Ended
- 24 Sept 2025
- Type of study
- Interventional
- Record updated
- 27 January 2025
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 20 criteriaShow less
Who can take part
- Diagnosis of GCA (Giant Cell Arteritis)
- AION characterized by sudden and painless loss of vision, accompanied by pallid swelling of the optic disc, of no more than one-week duration
- Age of 50 years or older
- Social insurance
Who cannot take part
- Patients with previously untreated tuberculosis, or imaging data suggestive of active and/or sequellar tuberculosis
- Biological targeting therapy within 3 months preceding the study
- History of any malignant neoplasm except adequately treated basal or squamous cell carcinoma of the skin or solid tumors treated with curative therapy and disease-free for at least 5 years
- Contraindication to steroids and/or aspirin administrated in the treatment
- Other ocular involvements related to GCA (central retinal artery occlusion, posterior ischemic optic neuropathy, transient ocular manifestations, occipital stroke), if not associated with AION
- HIV infected, hepatitis C infected, or a positive hepatitis B surface antigen if known before study inclusion
- Evidence of active infection
- History of recurrent infections, diverticulitis or intestinal ulceration and ASAT/ALAT > 5 * upper limit of normal, according to the Summary of Product Characteristics of tocilizumab
- Cytopenia, as defined by platelet count < 100 × 109/L (100,000/mm3), hemoglobin < 85 g/L (8.5 g/dL; 5.3 mmol/L), absolute neutrophil count < 2.0 × 109/L (2000/mm3), absolute lymphocyte count < 0.5 × 109/L (500/mm3)
- Insufficient kidney function, as defined by a serum creatinine of more than 3 mg/dL or creatinine clearance of 20 ml/min or less
- Pregnant or nursing (lactating) women confirmed by a positive βHCG laboratory test at the inclusion
- Insufficient liver function (Child Pugh C )
- Contraindication to and precaution in use of tocilizumab according to the summary product description
- Inability to provide informed consent
- Breastfeeding women and women with childbearing potential without highly effective contraception
- Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during study treatment and for 3 months after the last administration of tocilizumab
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
To determine if induction therapy by 4 subcutaneous tocilizumab injections over one month (every 7 days) in association to conventional steroid regimen could improve ocular outcome in acute anterior ischemic optic neuropathy (AION) related to Giant Cell Arteritis (GCA)
Data and sources
- Registry record
- Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
- Official title
- 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)
- Record updated
- 27 January 2025