Describe the Progression of Inflammatory Orbitopathy and the Biological Progression of Patients Receiving Second-line Treatment (HZN-IIT)

Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts

Status: Enrolling

Conditions: Basedow Disease

Study type: Observational

Funder types: Other

Identifiers

NCT07117981

P23-05

Details and patient eligibility

About

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

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.