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NCT Number: NCT06392906

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

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.

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Key information

Conditions

Thyroid Associated Ophthalmopathy Autoimmune Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Endocrine System Diseases Exophthalmos Eye Diseases Eye Diseases, Hereditary Genetic Diseases, Inborn Goiter Graves Disease Graves Ophthalmopathy Hyperthyroidism Immune System Diseases Orbital Diseases Thyroid Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

About this study

The research methodology of this study involves comparing the standard protocol of 10 radiation treatments with a modified approach comprising 5 treatments of daily External Beam Radiation Therapy (ERT).

The primary objective of this investigation is to assess whether reducing the number of radiation treatments while maintaining the effectiveness of the therapy can lead to improvements in the quality of life for patients with thyroid ophthalmopathy.

By comparing these two treatment regimens, researchers aim to evaluate the efficacy and safety of the abbreviated radiation schedule in managing the symptoms and progression of the disease.

Participants enrolled in the study will be randomized into two groups: one receiving the standard 10 treatments and the other receiving the modified 5-treatment regimen of daily ERT. Throughout the study period, participants will undergo comprehensive assessments to monitor changes in symptoms, vision, and quality of life. These evaluations will include ophthalmic examinations, imaging studies, and patient-reported outcome measures to capture both objective and subjective measures of treatment response.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Short course radiation therapy

Radiation

5 daily radiation treatments

Other names: 10 Gy in 5 fractions of radiation therapy

Standard course radiation therapy

Radiation

10 daily radiation treatments

Other names: 20 Gy in 10 fractions of radiation therapy

Primary outcomes

  1. Clinical Activity Score (CAS) change

    Time frame: 6 months after initiation of IVMP

    To evaluate the non-inferiority of outcomes in terms of the patient's proportion of converting from active (CAS > 4) to inactive eye disease (CAS <3) with CAS drop > 2 points, following orbital radiotherapy in combination with IVMP, comparing standard and reduced-dose orbital radiotherapy

    CAS score range from 1-7, initially and range from 1-10 at 1-3 months follow-up period. Higher CAS scores represented worse outcomes.

Secondary outcomes

  1. muscle and retrobulbar fat volume change

    Time frame: 6 months after initiation of IVMP

    To compare the change in volume of extra-ocular muscles and retro bulbar fat after orbital radiotherapy, comparing standard with reduced-dose orbital radiotherapy

  2. change in diplopia

    Time frame: 6 months after initiation of IVMP

    To compare the difference in prism deviation in primary gaze after standard and reduced-dose orbital radiotherapy

  3. change in quality of life

    Time frame: 6 months after initiation of IVMP

    To compare the difference in Graves' ophthalmopathy quality of life (GO-QOL) scores (Thai version) between standard and reduced-dose orbital radiotherapy. The total QOL scores range from 0 to 100 with higher scores indicating a better health status.

  4. Radiation toxicities

    Time frame: 6 months after initiation of IVMP

    To compare the summation of the Radiation Therapy Oncology Group (RTOG) toxicity scores (including dry eye, eye pain, keratitis, eyelid, conjunctiva, lacrimal gland, cornea, iris and skin toxicities) after standard and reduced-dose orbital radiotherapy. The RTOG gradings range from grade 0 to grade 4 in each item. The total toxicity scores range from 0-34, with a higher score indicating more severe side effects.

  5. Visual acuity (VA)

    Time frame: 6 months after initiation of IVMP

    -To compare the differences in visual acuity (logMAR) change after standard and reduced-dose orbital radiotherapy

  6. Visual field (VF)

    Time frame: 6 months after initiation of IVMP

    • To compare the differences of Humphrey's visual field (mean deviation) change after standard and reduced-dose orbital radiotherapy

Study contacts

Contact information is provided by the study sponsor or research team.

Janjira Petsuksiri, M.D.

CONTACT

[email protected]

66919966662

Wajana Thaweerat, M.D.

CONTACT

[email protected]

66941499212

Sponsors and collaborators

Lead sponsor

Janjira Petsuksiri

Other

Collaborators

  • Mahidol University

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
May 1, 2024
Registry last updated
Dec 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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