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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-70
SponsorJanjira Petsuksiri

About this trial

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 criteria

Qualifiers

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

Disqualifiers

Individuals with severe hypertension or diabetic retinopathy

Trial design

Treatments tested in this trial

  • Short course radiation therapy
  • Standard course radiation therapy

Treatment groups

68 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Janjira Petsuksiri

Lead sponsor

Mahidol University

Sponsor institution

Mahidol University

Collaborator