Therapeutic Efficacy of Orbital Radiotherapy in Patients With Graves'

Status Completed

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.

Clinical Trial 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). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05775185
Study type	Observational [Patient Registry]
Source	Medical University of Sofia
Contact
Status	Completed
Phase
Start date	July 25, 2017
Completion date	February 25, 2021

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Therapeutic Efficacy of Orbital Radiotherapy in Patients With Graves' Orbitopathy

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms