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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05775185
Other study ID # 21B /25.07.2017
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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