Actively Recruiting

Phase 3
Age: 18Years - 70Years
All Genders
NCT06392906

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

Led by Janjira Petsuksiri · Updated on 2024-12-04

68

Participants Needed

1

Research Sites

224 weeks

Total Duration

On this page

Sponsors

J

Janjira Petsuksiri

Lead Sponsor

M

Mahidol University

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 35 to 70 years
  • Active moderate to severe thyroid eye disease with Clinical Activity Score (CAS) greater than 4, with or without double vision, before starting IVMP
  • Poor response to 3 doses of IVMP (CAS drop less than 1) or CAS score above 3 after 3 doses of IVMP
  • Patients with double vision after 3 doses of IVMP
  • Patients with Graves' Ophthalmopathy who have maintained normal thyroid function (euthyroidism)
  • Non-pregnant adults
Not Eligible

You will not qualify if you...

  • Individuals with severe hypertension
  • Individuals with diabetic retinopathy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Faculty of Medicine Siriraj Hospital Mahidol University

Bangkok Noi, Thailand, 10700

Actively Recruiting

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Research Team

J

Janjira Petsuksiri, M.D.

CONTACT

W

Wajana Thaweerat, M.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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