Comparing short and standard radiation therapy for thyroid eye disease
Orbital Radiotherapy in Grave's Ophthalmopathy 1 Week vs 2 Weeks: A Phase II Randomized Controlled Trial (OraGO-1 Trial)
This study is testing if fewer sessions of radiation therapy can help people with moderate to severe thyroid eye disease just as well as the standard number of sessions, while also making their experience better.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 68 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Mahidol University Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Bangkok Noi) |
| Trial ID | NCT06392906 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of a shortened regimen of external beam radiation therapy (ERT) for patients with moderate to severe thyroid eye disease, comparing it to the standard treatment protocol. Participants will be randomized into two groups: one receiving 10 sessions of ERT and the other receiving 5 sessions. The study aims to determine if the reduced treatment schedule can maintain efficacy while improving patient quality of life. Comprehensive assessments will be conducted to monitor symptoms, vision, and overall treatment response throughout the trial.
Who should consider this trial
Good fit: Ideal candidates include adults aged 35 and older with active moderate to severe thyroid eye disease who have not responded adequately to steroid therapy.
Not a fit: Patients with severe hypertension or diabetic retinopathy may not benefit from this study due to exclusion criteria.
Why it matters
Potential benefit: If successful, this study could provide a more efficient treatment option for patients with thyroid eye disease, potentially reducing treatment time and improving quality of life.
How similar studies have performed: Other studies have shown promise in using radiation therapy for thyroid eye disease, but this specific approach of reducing treatment sessions is novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Bangkok Noi
- Faculty of Medicine Siriraj Hospital Mahidol University — Bangkok Noi, Thailand (Recruiting)
Study contacts
- Principal investigator: Janjira Petsuksiri, M.D. — Mahidol University
- Study coordinator: Janjira Petsuksiri, M.D.
- Email: janjira.pet@mahidol.ac.th
- Phone: 66919966662
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.