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Clinical Trials/NCT05775185
NCT05775185
Completed
Not Applicable

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

Medical University of Sofia1 site in 1 country26 target enrollmentJuly 25, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Graves Ophthalmopathy
Sponsor
Medical University of Sofia
Enrollment
26
Locations
1
Primary Endpoint
Efficacy of orbital radiotherapy
Status
Completed
Last Updated
2 years ago

Overview

Brief 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).

Registry
clinicaltrials.gov
Start Date
July 25, 2017
End Date
February 25, 2021
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Medical University of Sofia
Responsible Party
Principal Investigator
Principal Investigator

Mariya Stoynova

Principal investigator

Medical University of Sofia

Eligibility Criteria

Inclusion Criteria

  • Active moderate-to-severe Graves' orbitopathy

Exclusion Criteria

  • Contraindications for orbital radiotherapy

Outcomes

Primary Outcomes

Efficacy of orbital radiotherapy

Time Frame: 12 months

Effect on therapeutic response and individual ocular parameters

Effect of orbital radiotherapy on quality of life

Time Frame: 12 months

Effect of orbital radiotherapy on disease-specific quality of life

Study Sites (1)

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