Tracking inflammatory orbitopathy progression in people receiving second-line treatments

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

This project follows adults with moderate-to-severe Graves' orbitopathy who are receiving second-line treatments (immunosuppressants, radiotherapy, or biologics) to see how their eye inflammation and blood markers change over time.

Quick facts

• Study type: Observational
• Enrollment: 100 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts (Academic / other)
• Drugs / interventions: immunotherapy
• Locations: 9 sites (Paris, paris and 8 other locations)
• Trial ID: NCT07117981 on ClinicalTrials.gov

What this trial studies

This observational study follows adults with moderate to severe Basedow (Graves') orbitopathy who are treated with second-line therapies including immunosuppressants, radiotherapy, or biologic agents. Clinical activity scores (CAS), imaging data, and biological markers will be collected longitudinally to document clinical and biological progression. Eligible patients are corticosteroid-resistant or corticosteroid-dependent and are managed at participating French centers; patients with prior orbital decompression or severe corneal/optic nerve involvement are excluded. The study does not assign treatments but records real-world management and requires patient consent for reuse of health data.

Who should consider this trial

Good fit: Adults (≥18) with moderate-to-severe Graves' orbitopathy who are corticosteroid-resistant or -dependent, have CAS ≥3 (or CAS <3 with moderate-to-severe disease per EUGOGO), and are receiving immunotherapy, biologics, or radiotherapy are ideal candidates.

Not a fit: Patients who have had orbital bone or fat decompression, those with severe corneal involvement or optic neuropathy, or those not receiving second-line therapies are unlikely to benefit or qualify for this study.

Why it matters

Potential benefit: If successful, the results could help clinicians better time and choose second-line therapies and identify biological markers that predict who will improve.

How similar studies have performed: Some targeted biologic trials (for example teprotumumab) have shown clear clinical benefits in Graves' orbitopathy, but comparative real-world data on biological marker changes across varied second-line treatments remain limited.

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.

Where this trial is running

Paris, paris and 8 other locations

• Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts — Paris, paris, France (Recruiting)
• CHU Caen Normandie COTE DE NACRE — Caen, France (Recruiting)
• CHU Lyon - Hospices Civils de Lyon — Lyon, France (Recruiting)
• Hopital Saint Joseph — Marseille, France (Recruiting)
• CHU de Montpellier — Montpellier, France (Recruiting)
• CHU Nîmes — Nîmes, France (Recruiting)
• Hopital Fondation de Rothschild — Paris, France (Recruiting)
• CHU de Pontchaillou — Rennes, France (Recruiting)
• Hopital Civil / Nouvel Hopital Civil — Strasbourg, France (Recruiting)

Study contacts

• Study coordinator: Boris BIENVENU, DR

Conditions Basedow Disease