Describe the Progression of Inflammatory Orbitopathy and the Biological Progression of Patients Receiving Second-line Treatment

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCentre Hospitalier National d'Ophtalmologie des Quinze-Vingts

About this trial

Describe the progression of inflammatory orbitopathy and the biological progression of patients receiving second-line treatment (immunosuppressants, radiotherapy, or biotherapy).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients aged 18 and older with moderate to severe orbitopathy;

Patients followed in endocrinology with the goal of achieving euthyroidism;

Corticosteroid-resistant patients: patients who have received at least 3 weeks of treatment with 500 mg weekly corticosteroid boluses and have not shown improvement in the clinical activity score (CAS);

Corticosteroid-dependent patients: relapse with a CAS of 3 or higher when decreasing or stopping corticosteroid therapy;

Disqualifiers

Patients who have undergone bone or fat decompression surgery;

Patients with severe corneal involvement (Grade B or C; NO SPECS classification);

Patients with optic neuropathy (Grade B and C; NO SPECS classification);

Patients who have received 1 gram corticosteroid boluses for dysthyroid orbitopathy;

Trial population

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.

Trial design

Design model

Other

Time perspective

Retrospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

Other outcomes

Sponsors and contacts

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