Status:
COMPLETED
Thyroid Associated Orbitopathy Treatment by Methotrexate Against Triamcinolone Periocular Injections
Lead Sponsor:
Cairo University
Conditions:
Thyroid Associated Orbitopathy
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
Brief Summary
The study objective is to investigate the efficacy and safety of periocular injections of methotrexate in management of patients with active moderate to severe thyroid associated orbitopathy in compar...
Detailed Description
Recruited subjects will be randomized such that one orbit receives 3 periocular injections of methotrexate and the contralateral orbit receives 3 periocular injections of triamcinolone acetonide at da...
Eligibility Criteria
Inclusion
- Bilateral moderate to severe thyroid associated orbitopathy.
- Clinical Activity score (CAS) ≥ 3.
- Duration of thyroid associated orbitopathy \< 2 years
Exclusion
- Sight threatening thyroid associated orbitopathy (dysthyroid optic neuropathy or exposure keratopathy) in any eye.
- Glaucoma patients or those known to be steroid responders
- Presence of orbital infections or any infection in nearby structures as paranasal sinusitis or dental abscess
- Pregnancy
- Previous orbital or lid surgeries
- History of steroid therapy (oral, intravenous or periocular) or other immunosuppressive therapy within the previous 3 months
Key Trial Info
Start Date :
July 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 15 2022
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT05429450
Start Date
July 1 2020
End Date
July 15 2022
Last Update
September 21 2022
Active Locations (1)
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1
Cairo University
Cairo, Egypt