NCT05429450

Thyroid Associated Orbitopathy Treatment by Methotrexate Against Triamcinolone Periocular Injections

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Cairo University · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

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 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

Conditions

• Thyroid Associated Orbitopathy

Interventions

Type	Name	Description
DRUG	Methotrexate	Three periocular injections of methotrexate at week 0, week 3 and week 6.
DRUG	Triamcinolone Acetonide	Three periocular injections of triamcinolone acetonide at week 0, week 3 and week 6.

Timeline

• Start date: 2020-07-01
• Primary completion: 2022-07-01
• Completion: 2022-07-15
• First posted: 2022-06-23
• Last updated: 2022-09-21

Locations

1 site across 1 country: Egypt