NCT05775185

Therapeutic Efficacy of Orbital Radiotherapy in Patients With Graves' Orbitopathy

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 26 (actual)
• Sponsor: Medical University of Sofia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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: 1. How effective is orbital radiotherapy used as first- or second-line treatment in patients with Graves' orbitopathy? 2. 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

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: 1. How effective is orbital radiotherapy used as first- or second-line treatment in patients with Graves' orbitopathy? 2. 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).

Conditions

• Graves Ophthalmopathy

Interventions

Type	Name	Description
RADIATION	Orbital radiotherapy	Low dose fractionated orbital radiotherapy, total dose 20 Gy in 2-week period.

Timeline

• Start date: 2017-07-25
• Primary completion: 2021-02-25
• Completion: 2021-02-25
• First posted: 2023-03-20
• Last updated: 2023-10-19

Locations

1 site across 1 country: Bulgaria