Clinical trial Recruiting at 1 site Phase 3 Interventional Ages 18 to 70

Comparing short and standard radiation therapy for thyroid eye disease

Official title: Orbital Radiotherapy in Grave's Ophthalmopathy 1 Week vs 2 Weeks: A Phase II Randomized Controlled Trial (OraGO-1 Trial)

Run by Mahidol University · NCT06392906 · Data updated 2026-11-12

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

PhasePhase 3
Study typeInterventional
Ages18 Years to 70 Years
SexAll
Enrollment68 (estimated)
SponsorMahidol University
Academic / other
Drugs / interventionsradiation
Locations1 site (Bangkok Noi)
StatusRecruiting
StartedJuly 11, 2024
Main results expectedApril 30, 2028
Study endsOctober 31, 2028
Registry record updatedDecember 4, 2024
Trial IDNCT06392906 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably not a fit

Patients with severe hypertension or diabetic retinopathy may not benefit from this study due to exclusion criteria.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: Other studies have shown promise in using radiation therapy for thyroid eye disease, but this specific approach of reducing treatment sessions is novel.

Who can join: the full rules

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 it's running

  • Faculty of Medicine Siriraj Hospital Mahidol University
    Bangkok Noi, Thailand
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.