CompletedPhase 2

Thyroid Associated Orbitopathy Treatment by Methotrexate Against Triamcinolone Periocular Injections

Egypt18 participantsStarted 2020-07-01

Plain-language 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 comparison to periocular injections of triamcinolone acetonide.

Who can participate

Age range18 Years – 60 Years

SexALL

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Inclusion criteria

✓. Bilateral moderate to severe thyroid associated orbitopathy.
✓. Clinical Activity score (CAS) ≥ 3.
✓. Duration of thyroid associated orbitopathy \< 2 years

Exclusion criteria

✕. 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

What they're measuring

Change in clinical activity score (CAS)

Timeframe: 2 weeks, 1 month, 3 months and 6 months

Trial details

NCT IDNCT05429450

SponsorCairo University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-07-01

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