Thyroid Associated Orbitopathy Treatment by Methotrexate Against Triamcinolone Periocular Injections (TOMATO)

Cairo University (CU)

Status and phase: Completed; Phase 2

Conditions: Thyroid Associated Orbitopathy

Treatments: Drug: Methotrexate; Drug: Triamcinolone Acetonide

Study type: Interventional

Funder types: Other

Identifiers

NCT05429450

MD-139-2020

Details and patient eligibility

About

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.

Full 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 day 0, week 3 and week 6. All study subjects will be followed up for 6 months where outcome measures are assessed at 2 weeks, 1month, 3 months and 6 months after last injection

Enrollment: 18 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

1. Sight threatening thyroid associated orbitopathy (dysthyroid optic neuropathy or exposure keratopathy) in any eye.
2. Glaucoma patients or those known to be steroid responders
3. Presence of orbital infections or any infection in nearby structures as paranasal sinusitis or dental abscess
4. Pregnancy
5. Previous orbital or lid surgeries
6. History of steroid therapy (oral, intravenous or periocular) or other immunosuppressive therapy within the previous 3 months

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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18 participants in 2 patient groups

Methotrexate

Experimental group

Description:

Periocular injections of methotrexate

Treatment:

Drug: Methotrexate

Triamcinolone acetonide

Active Comparator group

Description:

Periocular injections of triamcinolone acetonide

Treatment:

Drug: Triamcinolone Acetonide