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OpenTrials
Completed

NCT Number: NCT05775185

Therapeutic Efficacy of Orbital Radiotherapy in Patients With Graves' Orbitopathy

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.

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Key information

About this study

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:

  • How effective is orbital radiotherapy used as first- or second-line treatment in patients with Graves' orbitopathy?
  • 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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Active moderate-to-severe Graves' orbitopathy

Exclusion criteria

  • Contraindications for orbital radiotherapy

Treatment and study plan

Orbital radiotherapy

Radiation

Low dose fractionated orbital radiotherapy, total dose 20 Gy in 2-week period.

Primary outcomes

  1. Efficacy of orbital radiotherapy

    Time frame: 12 months

    Effect on therapeutic response and individual ocular parameters

  2. Effect of orbital radiotherapy on quality of life

    Time frame: 12 months

    Effect of orbital radiotherapy on disease-specific quality of life

Sponsors and collaborators

Lead sponsor

Medical University of Sofia

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Mar 20, 2023
Registry last updated
Oct 19, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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