Thyroid Associated Orbitopathy Treatment by Methotrexate Against Triamcinolone Periocular Injections

Phase 2

Completed

• Conditions: Thyroid Associated Orbitopathy
• Interventions: Drug: Methotrexate; Drug: Triamcinolone Acetonide

• Registration Number: NCT05429450
• Lead Sponsor: Cairo University

Brief 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

Study Timeline

• Study Start: 2020-07-01
• Study First Submitted: 2022-06-18
• Study First Submitted QC: 2022-06-18
• Study First Posted: 2022-06-23
• Primary Completion: 2022-07-01
• Study Completion: 2022-07-15
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-17
• Last Update Posted: 2022-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Methotrexate	Methotrexate	Periocular injections of methotrexate
Triamcinolone acetonide	Triamcinolone Acetonide	Periocular injections of triamcinolone acetonide

Primary Outcome Measures

Name	Time	Method
Change in clinical activity score (CAS)	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 Outcome Measures

Name	Time	Method
Change in proptosis	2 weeks, 1 month, 3 months and 6 months	Mean change in proptosis measured in millimeters by an exopthalmometer compared to baseline proptosis
Change in lid aperture	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
Percentage of overall responders	3 months and 6 months	A participant is considered an overall responder if 2 or more of the following: 1. Improvement of CAS ≥ 2 points.; 2. Improvement of proptosis ≥ 2 mm.; 3. Improvement of lid aperture ≥ 2 mm.; 4. Improvement of soft tissue signs ≥ 1 grade; 5. Improvement of EOM ductions

Trial Locations

Locations (1)

Cairo University; 🇪🇬 Cairo, Egypt