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

NCT06392906 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2024-12-04

No results posted yet for this study

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.

Conditions

  • Thyroid Associated Ophthalmopathy

Interventions

RADIATION

Short course radiation therapy

5 daily radiation treatments

RADIATION

Standard course radiation therapy

10 daily radiation treatments

Sponsors & Collaborators

  • Mahidol University

    collaborator OTHER

  • Janjira Petsuksiri

    lead OTHER

Principal Investigators

  • Janjira Petsuksiri, M.D. · Mahidol University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-11
Primary Completion
2028-04-30
Completion
2028-10-31

Countries

  • Thailand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06392906 on ClinicalTrials.gov