Thyroid Associated Orbitopathy Treatment by Methotrexate Against Triamcinolone Periocular Injections

Thyroid Associated Orbitopathy Clinical Trial

— TOMATO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05429450
• Other study ID #: MD-139-2020
• Status: Completed
• Phase: Phase 2
• Start date: July 1, 2020
• Est. completion date: July 15, 2022

Study information

• Verified date: September 2022
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: July 15, 2022
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Graves Ophthalmopathy
• Thyroid Associated Orbitopathy
• Thyroid Diseases

Intervention

Drug:
• Methotrexate
Three periocular injections of methotrexate at week 0, week 3 and week 6.
• Triamcinolone Acetonide
Three periocular injections of triamcinolone acetonide at week 0, week 3 and week 6.

Locations

Country	Name	City	State
Egypt	Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in clinical activity score (CAS)	Mean change in clinical activity score from baseline. CAS is a 10-point score (0-10) with disease considered active if CAS is >3.	2 weeks, 1 month, 3 months and 6 months
Secondary	Change in proptosis	Mean change in proptosis measured in millimeters by an exopthalmometer compared to baseline proptosis	2 weeks, 1 month, 3 months and 6 months
Secondary	Change in lid aperture	Mean change in lid aperture (distance between upper and lower lid margin measured in millimeters by a ruler	2 weeks, 1 month, 3 months and 6 months
Secondary	Percentage of overall responders	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	3 months and 6 months