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Completed

NCT Number: NCT05429450

Thyroid Associated Orbitopathy Treatment by Methotrexate Against Triamcinolone Periocular Injections

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.

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Key information

Conditions

Thyroid Associated Orbitopathy

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Cairo University

Cairo, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

methotrexate

Drug

Three periocular injections of methotrexate at week 0, week 3 and week 6.

Triamcinolone Acetonide

Drug

Three periocular injections of triamcinolone acetonide at week 0, week 3 and week 6.

Primary outcomes

  1. Change in clinical activity score (CAS)

    Time frame: 2 weeks, 1 month, 3 months and 6 months

    Mean change in clinical activity score from baseline. CAS is a 10-point score (0-10) with disease considered active if CAS is >3.

Secondary outcomes

  1. Change in proptosis

    Time frame: 2 weeks, 1 month, 3 months and 6 months

    Mean change in proptosis measured in millimeters by an exopthalmometer compared to baseline proptosis

  2. Change in lid aperture

    Time frame: 2 weeks, 1 month, 3 months and 6 months

    Mean change in lid aperture (distance between upper and lower lid margin measured in millimeters by a ruler

  3. Percentage of overall responders

    Time frame: 3 months and 6 months

    A participant is considered an overall responder if 2 or more of the following:

    • Improvement of CAS ≥ 2 points.
    • Improvement of proptosis ≥ 2 mm.
    • Improvement of lid aperture ≥ 2 mm.
    • Improvement of soft tissue signs ≥ 1 grade
    • Improvement of EOM ductions

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Comparative Study on the Efficacy of Periocular Methotrexate Versus Periocular Triamcinolone Injections in Management of Thyroid Associated Orbitopathy

Acronym: TOMATO

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jun 23, 2022
Registry last updated
Sep 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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