NCT06392906 Orbital Radiotherapy in Grave's Ophthalmopathy 1 Week vs 2 Weeks (OraGO-1 Trial)
| NCT ID | NCT06392906 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Janjira Petsuksiri |
| Condition | Thyroid Associated Ophthalmopathy |
| Study Type | INTERVENTIONAL |
| Enrollment | 68 participants |
| Start Date | 2024-07-11 |
| Primary Completion | 2028-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 68 participants in total. It began in 2024-07-11 with a primary completion date of 2028-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * 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 Criteria: * Individuals with severe hypertension or diabetic retinopathy
Contact & Investigator
Janjira Petsuksiri, M.D.
PRINCIPAL INVESTIGATOR
Mahidol University
Frequently Asked Questions
Who can join the NCT06392906 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Thyroid Associated Ophthalmopathy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06392906 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 68 participants.
Is NCT06392906 currently recruiting?
Yes, NCT06392906 is actively recruiting participants. Contact the research team at janjira.pet@mahidol.ac.th for enrollment information.
Where is the NCT06392906 trial being conducted?
This trial is being conducted at Bangkok Noi, Thailand.
Who is sponsoring the NCT06392906 clinical trial?
NCT06392906 is sponsored by Janjira Petsuksiri. The principal investigator is Janjira Petsuksiri, M.D. at Mahidol University. The trial plans to enroll 68 participants.