An observational study in Basedow Disease, sponsored by Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts. Recruiting at 9 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-15.
Sponsored by Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts · Observational
Describe the progression of inflammatory orbitopathy and the biological progression of patients receiving second-line treatment (immunosuppressants, radiotherapy, or biotherapy).
162 studies on the registry are indexed under Graves Disease; 53 are open to participants now.
This study's planned enrollment of 100 is below the median of 120 across 56 observational studies indexed under Graves Disease.
Browse Graves Disease studies →Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts is the lead sponsor of 28 studies on the registry; 16 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The data collection concerns patients with Graves' orbitopathy who have received corticosteroid treatment and second-line treatment (immunosuppressants, biotherapy) since 2015, 2021, or 2022. A decision was made to limit the inclusion to patients who started second-line treatment between January 2022 and December 2023, with clinical follow-up until the end of 2024, in order to limit selection bias and ensure an adequate follow-up period.
The inclusion period extends until June 2025.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Response to second-line basedow treatment
Practices in France regarding the use of these second-line treatments appear to be heterogeneous, and their effectiveness has never been compared through randomized studies. investigators propose to collect and analyze the therapeutic outcomes of second-line treatment in patients with Graves' orbitopathy. The data collection concerns patients with Graves' orbitopathy who have received corticosteroid therapy and a second-line treatment (immunosuppressant, biotherapy) since 2022. Data from the medical records of patients included.
Time frame: Patients who started a second-line treatment between January 2022 and December 2023, with clinical follow-up until the end of 2024, were included in order to minimize selection bias. inclusion period: until december 2025
Plan to share: No — Each center remains the owner of its data, so it is possible to extract and send data from each center via the eCRF for theses or publications
Started Nov 2024 (actual). Primary completion is estimated for Dec 2025, 13 months after the start.
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Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts