Comparison of the Effectiveness of Two Glucocorticoid Regimens for Treatment of Graves' Orbitopathy
NCT ID: NCT05793359
Last Updated: 2023-03-31
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
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COMPLETED
62 participants
OBSERVATIONAL
2017-07-25
2021-02-25
Brief Summary
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1. Are the two glucocorticoid regimens similarly effective?
2. Do the two glucocorticoid regimens have similar safety profile? The patients involved are treated with one of the two glucocorticoid regimens. Their ocular status, therapeutic response and quality of life reassessed during the treatment, at its end, and 3 month later.
Detailed Description
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1. Are the two glucocorticoid regimens similarly effective?
2. Do the two glucocorticoid regimens have similar safety profile? The patients involved are treated with one of the two glucocorticoid regimens. The first group is treated with modified monthly regimen, including 3 pulses of 3 infusions of 500 mg methylprednisolone administered in three consecutive months, with application of 125 mg methylprednisolone intramuscularly once per week between the pulses. Total cumulative dose - 5.5. g., duration - 3 months. After completion of the venous infusions, a low dose peroral glucocorticoid therapy is prescribed for the next 3 months. The second group is treated with weekly glucocorticoid regimen: 6 infusions of 500 mg methylprednisolone during the first 6 weeks followed by 6 infusions of 250 mg methylprednisolone during the next 6 weeks. Total cumulative dose - 4.5 g., duration - 3 months. Patients' ocular status and therapeutic response are assessed at 1st, 3rd and 6th months; quality of life - at 3rd and 6th month.
Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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Modified monthly regimen
Treatment with 3 pulses of 3 infusions of 500 mg methylprednisolone on 3 consecutive months with intramuscular administration of 125 mg methylprednisolone per week between the pulses. Additional low dose peroral treatment after completion of the pulses.
Methylprednisolone
methylprednisolone applied as intravenous infusions or intramuscularly
Weekly regimen
Treatment with 6 infusions of 500 mg methylprednisolone during the first 6 weeks, followed by 6 infusions of 250 mg methylprednisolone during the next 6 weeks.
Methylprednisolone
methylprednisolone applied as intravenous infusions or intramuscularly
Interventions
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Methylprednisolone
methylprednisolone applied as intravenous infusions or intramuscularly
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Without previous treatment with glucocorticoids or orbital radiotherapy
* Euthyroid state
Exclusion Criteria
* Previously treated Graves' orbitopathy
* Mild or sight-threatening form of Graves' orbitopathy
* Inactive moderate-to-severe Graves' orbitopathy
* Contraindications for glucocorticoid treatment
18 Years
ALL
No
Sponsors
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Medical University of Sofia
OTHER
Responsible Party
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Mariya Stoynova
Principal investigator
Principal Investigators
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Mariya D Stoynova, PhD
Role: PRINCIPAL_INVESTIGATOR
Medical University of Sofia: Medicinski universitet-Sofia
Locations
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University Hospital of Endocrinology
Sofia, , Bulgaria
Countries
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References
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Stoynova MA, Shinkov AD, Dimitrova ID, Yankova IA, Kovatcheva RD. Comparison of the efficacy of two different glucocorticoid regimens for treatment of active moderate-to-severe Graves' orbitopathy. Int Ophthalmol. 2023 Dec;43(12):4747-4757. doi: 10.1007/s10792-023-02875-z. Epub 2023 Sep 12.
Other Identifiers
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21A /25.07.2017
Identifier Type: -
Identifier Source: org_study_id