RecruitingPhase 3NCT06392906

Orbital Radiotherapy in Grave's Ophthalmopathy 1 Week vs 2 Weeks (OraGO-1 Trial)

Orbital Radiotherapy in Grave's Ophthalmopathy 1 Week vs 2 Weeks: A Phase II Randomized Controlled Trial (OraGO-1 Trial)


Sponsor

Janjira Petsuksiri

Enrollment

68 participants

Start Date

Jul 11, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria5

  • 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)

Exclusion Criteria1

  • Individuals with severe hypertension or diabetic retinopathy

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Interventions

RADIATIONShort course radiation therapy

5 daily radiation treatments

RADIATIONStandard course radiation therapy

10 daily radiation treatments


Locations(1)

Faculty of Medicine Siriraj Hospital Mahidol University

Bangkok Noi, Thailand

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NCT06392906


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