Thyroid Associated Orbitopathy Treatment by Methotrexate Against Triamcinolone Periocular Injections

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Thyroid Associated Orbitopathy

Intervention / Treatment
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* Drug: Methotrexate
* Drug: Triamcinolone Acetonide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Methotrexate<br>Periocular injections of methotrexate | Drug: Methotrexate<br>* Three periocular injections of methotrexate at week 0, week 3 and week 6.<br>|
| Active Comparator: Triamcinolone acetonide<br>Periocular injections of triamcinolone acetonide | Drug: Triamcinolone Acetonide<br>* Three periocular injections of triamcinolone acetonide at week 0, week 3 and week 6.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Thyroid associated orbitopathy, Grave's orbitopathy, Periocular injections, Methotrexate, Triamcinolone