Actively Recruiting
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
Eligibility Criteria
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
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
Trial Site Locations
Total: 1 location
1
Faculty of Medicine Siriraj Hospital Mahidol University
Bangkok Noi, Thailand, 10700
Actively Recruiting
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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