Therapeutic Efficacy of Orbital Radiotherapy in Patients With Graves' Orbitopathy
NCT ID: NCT05775185
Last Updated: 2023-10-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
26 participants
OBSERVATIONAL
2017-07-25
2021-02-25
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Analysis Between the Results of Two Surgical Techniques of Orbital Decompression in Patients With Graves Orbitopathy
NCT03278964
Modified Orbital Decompression in the Treatment of Moderate-to-severe Grave's Ophthalmopathy
NCT06588764
Comparison Study Between Two Techniques for Correction of Upper Lid Retraction in Patients With Grave's Orbitopathy
NCT01999790
Customized Multiple Orbital Wall Decompression for Sight-threatening Graves's Ophthalmopathy
NCT05627401
Comparison Between Two Techniques of Subthreshold Diode Laser Cyclophotocoagulation in Refractory Glaucoma
NCT05230355
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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).
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_ONLY
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
Orbital radiotherapy
Low dose fractionated orbital radiotherapy, total dose 20 Gy in 2-week period.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Orbital radiotherapy
Low dose fractionated orbital radiotherapy, total dose 20 Gy in 2-week period.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Medical University of Sofia
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Mariya Stoynova
Principal investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Mariya A Stoynova
Role: PRINCIPAL_INVESTIGATOR
Medical University of Sofia: Medicinski universitet-Sofia
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University Hospital of Endocrinology
Sofia, , Bulgaria
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
21B /25.07.2017
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.