Thyroid Associated Orbitopathy Treatment by Methotrexate Against Triamcinolone Periocular Injections

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-01

Study Completion Date

2022-07-15

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.

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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

Conditions

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Thyroid Associated Orbitopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Methotrexate

Periocular injections of methotrexate

Group Type EXPERIMENTAL

Methotrexate

Intervention Type DRUG

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

Triamcinolone acetonide

Periocular injections of triamcinolone acetonide

Group Type ACTIVE_COMPARATOR

Triamcinolone Acetonide

Intervention Type DRUG

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

Interventions

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Methotrexate

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

Intervention Type DRUG

Triamcinolone Acetonide

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No