Clinical trial NCT05775185: Therapeutic Efficacy of Orbital Radiotherapy in Patients With Graves' Orbitopathy
Official title: Changes in Therapeutic Response, Ocular Manifestations of Graves' Orbitopathy and Quality of Life During the First Year After Orbital Radiotherapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Graves Ophthalmopathy
Lead sponsor: Medical University of Sofia
Sponsor class: OTHER
First posted: 2023-03-20
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population consists of 26 patients with active moderate-to-severe Graves' orbitopathy. Eight of them have untreated disease and the rest have been already treated with systemic glucocorticoids. Patients with contraindications for orbital radiotherapy are excluded.

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).

Eligibility criteria: Inclusion Criteria:

- Active moderate-to-severe Graves' orbitopathy

Exclusion Criteria:

* Contraindications for orbital radiotherapy

Primary outcomes:
measure: Efficacy of orbital radiotherapy
timeFrame: 12 months
measure: Effect of orbital radiotherapy on quality of life
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sofia
country: Bulgaria
facility: University Hospital of Endocrinology
Study officials:
affiliation: Medical University of Sofia: Medicinski universitet-Sofia
name: Mariya A Stoynova
role: PRINCIPAL_INVESTIGATOR
References: