Therapeutic Efficacy of Orbital Radiotherapy in Patients With Graves' Orbitopathy

Graves Ophthalmopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05775185
• Other study ID #: 21B /25.07.2017
• Status: Completed
• Start date: July 25, 2017
• Est. completion date: February 25, 2021

Study information

• Verified date: October 2023
• Source: Medical University of Sofia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: February 25, 2021
• Est. primary completion date: February 25, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Active moderate-to-severe Graves' orbitopathy

Exclusion Criteria:

• Contraindications for orbital radiotherapy

Related Conditions & MeSH terms

• Eye Diseases
• Graves Ophthalmopathy

Intervention

Radiation:
• Orbital radiotherapy
Low dose fractionated orbital radiotherapy, total dose 20 Gy in 2-week period.

Locations

Country	Name	City	State
Bulgaria	University Hospital of Endocrinology	Sofia

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Sofia

Country where clinical trial is conducted

Bulgaria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of orbital radiotherapy	Effect on therapeutic response and individual ocular parameters	12 months
Primary	Effect of orbital radiotherapy on quality of life	Effect of orbital radiotherapy on disease-specific quality of life	12 months