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Periocular Methotrexate vs Triamcinolone in Thyroid Associated Orbitopathy
NCT05429450Phase 2
Key facts
- Status
- Completed
- Start
- Jul 2020
- Primary completion
- Jul 2022
- Countries
- 1
- Sponsor
- Cairo University
- Modality
- Orthosteric Ligands
- Drugs
- methotrexate
- Conditions
- thyroid-associated orbitopathy (TED)
01
Overview
Phase 2, randomised, double-blind trial of methotrexate in thyroid-associated orbitopathy (TED) (2 arms), sponsored by Cairo University. Primary endpoint: Change in Clinical Activity Score at 6 months. Started Jul 2020; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Methotrexate
Periocular injections of methotrexate
Triamcinolone acetonide
Periocular injections of triamcinolone acetonide
03
Who it enrols
Patients with bilateral active moderate to severe thyroid associated orbitopathy (CAS >= 3) and duration < 2 years. Excludes sight-threatening disease, glaucoma, infection, pregnancy, and recent steroid/immunosuppressive therapy.
04
Endpoints
Primary
Change in Clinical Activity Score
Secondary
Change in proptosis
Change in lid aperture
Percentage of overall responders
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