Therapeutic Efficacy of Orbital Radiotherapy in Patients With Graves' Orbitopathy

NCT05775185 | Completed

• 1 other identifier: 21B /25.07.2017
• Study Type: observational
• Target: 26
• Locations: 1 country
• Sites: 1

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. 1.How effective is orbital radiotherapy used as first- or second-line treatment in patients with Graves' orbitopathy?
2. 2.How does the quality of life changes after orbital radiotherapy?

Conditions

Graves Ophthalmopathy

Outcome Measures

Primary Outcomes (2)

• Efficacy of orbital radiotherapy

  Effect on therapeutic response and individual ocular parameters

  12 months

• Effect of orbital radiotherapy on quality of life

  Effect of orbital radiotherapy on disease-specific quality of life

  12 months

Study Arms (1)

Orbital radiotherapy

The study includes only one group of patients treated with orbital radiotherapy for 2-week period, a total dose of 20 Gy, 2Gy for each session.

Radiation: Orbital radiotherapy

Interventions

Orbital radiotherapy RADIATION

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

Orbital radiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• \- Active moderate-to-severe Graves' orbitopathy

You may not qualify if:

• Contraindications for orbital radiotherapy

Sponsors & Collaborators

• Medical University of Sofia: lead

Study Sites (1)

University Hospital of Endocrinology

Sofia, 1000, Bulgaria

Location

Related Publications (1)

• Stoynova MA, Shinkov AD, Novoselski MT, Petrova VV, Dimitrova ID, Yankova IA, Kovatcheva RD. Changes in therapeutic response, ocular manifestations of Graves' orbitopathy and quality of life during the first year after orbital radiotherapy. Int Ophthalmol. 2023 Nov;43(11):4305-4314. doi: 10.1007/s10792-023-02842-8. Epub 2023 Aug 10.

  PMID: 37561249 DERIVED

MeSH Terms

Conditions

Graves Ophthalmopathy

Condition Hierarchy (Ancestors)

Eye Diseases, Hereditary; Eye Diseases; Graves Disease; Exophthalmos; Orbital Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Goiter; Thyroid Diseases; Endocrine System Diseases; Hyperthyroidism; Autoimmune Diseases; Immune System Diseases

Study Officials

• Mariya A Stoynova

  Medical University of Sofia: Medicinski universitet-Sofia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: March 7, 2023
• First Posted: March 20, 2023
• Study Start: July 25, 2017
• Primary Completion: February 25, 2021
• Study Completion: February 25, 2021
• Last Updated: October 19, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

BU (1)