Therapeutic Efficacy of Orbital Radiotherapy in Patients With Graves' Orbitopathy

Medical University of Sofia

Status: Completed

Conditions: Graves Ophthalmopathy

Treatments: Radiation: Orbital radiotherapy

Study type: Observational

Funder types: Other

Identifiers

NCT05775185

21B /25.07.2017

Details and patient eligibility

About

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.

Full 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).

Enrollment: 26 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Active moderate-to-severe Graves' orbitopathy

Exclusion criteria

• Contraindications for orbital radiotherapy

Trial design

26 participants in 1 patient group

Orbital radiotherapy

Description:

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.

Treatment:

Radiation: Orbital radiotherapy