BridgeMD
Efficacy of tocilizumab in the treatment of acute anterior ischemic optic neuropathy optic neuropathy in Horton's disease
EU CTIS ID: 2024-519977-20-00
What this study is testing
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)
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- Other ocular involvements related to GCA (central retinal artery occlusion, posterior ischemic optic neuropathy, transient ocular manifestations, occipital stroke), if not associated with AION
- 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 liver function (Child Pugh C )
- Insufficient kidney function, as defined by a serum creatinine of more than 3 mg/dL or creatinine clearance of 20 ml/min or less
- Patients with previously untreated tuberculosis, or imaging data suggestive of active and/or sequellar tuberculosis
- HIV infected, hepatitis C infected, or a positive hepatitis B surface antigen if known before study inclusion
See the full eligibility criteria
- 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
- Other ocular involvements related to GCA (central retinal artery occlusion, posterior ischemic optic neuropathy, transient ocular manifestations, occipital stroke), if not associated with AION
- 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 liver function (Child Pugh C )
- Insufficient kidney function, as defined by a serum creatinine of more than 3 mg/dL or creatinine clearance of 20 ml/min or less
- Patients with previously untreated tuberculosis, or imaging data suggestive of active and/or sequellar tuberculosis
- HIV infected, hepatitis C infected, or a positive hepatitis B surface antigen if known before study inclusion
- Contraindication to and precaution in use of tocilizumab according to the summary product description
- Inability to provide informed consent
- Biological targeting therapy within 3 months preceding the study
- Evidence of active infection
- 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
- 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
- Contraindication to steroids and/or aspirin administrated in the treatment
- Breastfeeding women and women with childbearing potential without highly effective contraception.
- Pregnant or nursing (lactating) women confirmed by a positive βHCG laboratory test at the inclusion
- 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.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.