Status:
COMPLETED
Sirolimus in Graves' Orbitopathy
Lead Sponsor:
University of Pisa
Conditions:
Graves Ophthalmopathy
Eligibility:
All Genders
18-75 years
Brief Summary
Graves' Orbitopathy (GO) is a disabling and disfiguring condition associated with Graves' Disease, due to autoimmunity against antigens expressed by the thyroid and orbital tissues, and resulting in o...
Detailed Description
Study Design: observational Thirty consecutive patients with moderate-to-severe and active GO treated with sirolimus (15 patients) or methylprednisolone (15 patients) observance 18 consecutive months...
Eligibility Criteria
Inclusion
- Patients willing and capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form
- A moderate-to-severe GO, defined as the presence of at least one of the following criteria: an exophthalmos ≥2 mm compared with normal values for sex and race; presence of inconstant to constant diplopia; a lid retraction ≥2 mm
- Active GO: CAS (4) ≥2 out of 7 points in the most affected eye
- Previous GO treatment with glucocorticoids and/or orbital radiotherapy and/or orbital decompressive surgery, performed more than 24 weeks before the current treatment
- Male and female patients of age: 18-75 years
Exclusion
- Optic neuropathy
- Treatment with glucocorticoids or other immunosuppressive medications, and/or selenium, and/or orbital radiotherapy and/or orbital decompressive surgery in the 24 weeks preceding the current treatment
- Mental illness that prevents patients from comprehensive, written informed consent
Key Trial Info
Start Date :
January 15 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 15 2021
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05345119
Start Date
January 15 2020
End Date
June 15 2021
Last Update
April 25 2022
Active Locations (1)
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1
Endocrinologia II
Pisa, PI, Italy, 56124