Orbital Radiotherapy in Grave's Ophthalmopathy 1 Week vs 2 Weeks (OraGO-1 Trial)
Recruiting now · Phase 3
Conditions studied: Thyroid Associated Ophthalmopathy
In brief
Thyroid ophthalmopathy, also known as thyroid eye disease or Graves' ophthalmopathy, is a condition characterized by inflammation and swelling of the tissues around the eyes, often accompanied by protrusion of the eyeballs. This condition can lead to significant discomfort, visual disturbances, and in severe cases, permanent vision loss. Primary treatment modalities are intravenous methylprednisolone (IVMP) and other medications for patients with moderate to severe and active thyroid eye disease. In addition, external beam radiation therapy (ERT) is an another treatment option in combination with IVMP. Radiation therapy delivers targeted doses of ionizing radiation to the affected orbital tissues, effectively reducing inflammation. This approach is particularly beneficial for patients who may not respond adequately to steroid therapy alone or those who experience recurrent disease flares. This study will test the efficacy of a shortened treatment regimen comprising 5 sessions of ERT to a standard protocol of 10 treatments. The primary aim is to ascertain the effectiveness of shorted radiation treatment while improving patients' quality of life.
Key facts
- Study ID
- NCT06392906
- Run by
- Janjira Petsuksiri
- People needed
- 68
- Starts
- 2024-07-11
- Expected to finish
- 2028-10-31
- Last updated by the study team
- 2024-12-04
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patient with active moderate to severe thyroid eye disease with a CAS > 4 with/ without diplopia before starting IVMP
- Patient with poor response to 3 doses of IVMP (CAS drop < 1) หรือ CAS score > 3 after 3 doses of IVMP
- Patients with diplopia after 3 doses of IVMP
- Patients with Graves' Ophthalmopathy who have maintained euthyroidism
- Non-pregnant adults (aged 35 years or older)
You may not qualify if…
- Individuals with severe hypertension or diabetic retinopathy
Where it is running
- Faculty of Medicine Siriraj Hospital Mahidol University — Bangkok Noi, Thailand (enrolling)
Full record on ClinicalTrials.gov
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