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ClinicalTrials.gov ID

NCT07117981

Lead Sponsor

Centre Hospitalier National d'Ophtalmologie des Quinze-VingtsOTHER

Overall Status

Recruiting

Study Type

Observational

Enrollment

100Estimated

Last Update Posted

Aug 15, 2025Actual

Start Date

Nov 1, 2024Actual

Primary Completion Date

Dec 2025Estimated

Completion Date

Dec 2025Estimated

Official Title

Treatment of Graves' Orbitopathy in Patients Failing Corticosteroid Therapy: Multicenter National Retrospective Study- Basedow

Brief Summary

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

• Basedow Disease

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No data available

Eligibility Criteria

Inclusion Criteria:

• 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;
• Patients with a CAS ≥ 3 or CAS <3 with moderate to severe orbitopathy (according to EUGOGO);
• Patients treated with immunotherapy, biotherapy, or radiotherapy as second-line treatment;
• Patients who are not opposed to the reuse of their health data.

Exclusion Criteria:

• 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;
• Patients who have opposed the reuse of their health data.

Observational Model

Other

Time Perspective

Retrospective

Lead Sponsor

Centre Hospitalier National d'Ophtalmologie des Quinze-VingtsOTHER

OLIVIER.GILLY@chu-nimes.fr