Therapeutic Efficacy of Orbital Radiotherapy in Patients With Graves' Orbitopathy

Study Overview
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Brief Summary
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The purpose of the present interventional study is to assess the changes in the therapeutic response, ocular manifestations of Graves' orbitopathy and quality of life during the first year after orbital radiotherapy. The main questions it aim to answer are: How effective is orbital radiotherapy used as first- or second-line treatment in patients with Graves' orbitopathy? How does the quality of life changes after orbital radiotherapy? Participants have active moderate-to-severe Graves' orbitopathy and are treated with low dose fractionated orbital radiotherapy for two weeks. During the follow-up period they undergo regular ocular examinations and fill out a disease-specific questionnaire.

Detailed Description
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Orbital radiotherapy is a well-established second-line therapy for moderate-to-severe forms of Graves' orbitopathy. However, the question about it efficacy is still controversial. The purpose of the present interventional study is to assess the changes in the therapeutic response, ocular manifestations of Graves' orbitopathy and quality of life during the first year after orbital radiotherapy. The main questions it aim to answer are: How effective is orbital radiotherapy used as first- or second-line treatment in patients with Graves' orbitopathy? How does the quality of life changes after orbital radiotherapy? Participants have active moderate-to-severe Graves' orbitopathy untreated or already treated with systemic glucocorticoids and are referred to low dose fractionated orbital radiotherapy, total dose 20 Gy divided into 10 sessions, 2 Gy for each session. A concomitant intake of low-dose glucocorticoids is prescribed to all patient. During the follow-up period they undergo regular ocular examinations (at 1st, 3rd, 6th and 12th month), which includes comprehensive ocular status, hormonal and immunological testing and evaluation of the current therapeutic response. The patients also fill out a disease-specific questionnaire (at 3rd, 6th and 12th months).

Official Title
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Changes in Therapeutic Response, Ocular Manifestations of Graves' Orbitopathy and Quality of Life During the First Year After Orbital Radiotherapy

Conditions
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Graves Ophthalmopathy

Intervention / Treatment
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* Radiation: Orbital radiotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Active moderate-to-severe Graves' orbitopathy Exclusion Criteria: Contraindications for orbital radiotherapy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Orbital radiotherapy<br>The study includes only one group of patients treated with orbital radiotherapy for 2-week period, a total dose of 20 Gy, 2Gy for each session. | Radiation: Orbital radiotherapy<br>* Low dose fractionated orbital radiotherapy, total dose 20 Gy in 2-week period.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of orbital radiotherapy | Effect on therapeutic response and individual ocular parameters | 12 months | 
| Effect of orbital radiotherapy on quality of life | Effect of orbital radiotherapy on disease-specific quality of life | 12 months |