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Orbital Radiotherapy in Grave's Ophthalmopathy 1 Week vs 2 Weeks (OraGO-1 Trial) - Trial NCT06392906

Access comprehensive clinical trial information for NCT06392906 through Pure Global AI's free database. This Phase 3 trial is sponsored by Janjira Petsuksiri and is currently Not yet recruiting. The study focuses on Thyroid Associated Ophthalmopathy. Target enrollment is 68 participants.

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NCT06392906
Phase 3
Not yet recruiting
radiation
Trial Details
ClinicalTrials.gov โ€ข NCT06392906
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Orbital Radiotherapy in Grave's Ophthalmopathy 1 Week vs 2 Weeks (OraGO-1 Trial)
Orbital Radiotherapy in Grave's Ophthalmopathy 1 Week vs 2 Weeks: A Phase II Randomized Controlled Trial (OraGO-1 Trial)

Study Focus

Short course radiation therapy

Interventional

radiation

Sponsor & Location

Janjira Petsuksiri

Mahidol University

Bangkok Noi, Thailand

Timeline & Enrollment

Phase 3

May 01, 2024

Oct 31, 2028

68 participants

Primary Outcome

Clinical Activity Score (CAS) change

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.

ICD-10 Classifications

Thyroiditis
Disorders of thyroid gland
Thyroiditis, unspecified
Other disorders of thyroid
Disorder of thyroid, unspecified

Data Source

ClinicalTrials.gov

NCT06392906

Non-Device Trial