Local Betamethasone Versus Triamcinolone Injection in Management of Thyroid Eye Disease

Assiut University

Status and phase: Completed; Phase 3; Phase 2

Conditions: Thyroid Eye Disease

Treatments: Procedure: peri-levator and retrobulbar triamcinolone injection; Procedure: peri-levator and retrobulbar betamethasone injection; Procedure: peri-levator betamethasone injection; Procedure: peri-levator triamcinolone injection

Study type: Interventional

Funder types: Other

Identifiers

NCT04976816

LBVTIMTED

Details and patient eligibility

About

To compare the efficacy of local injections of two different types of steroid (betamethasone suspension versus triamcinolone acetate) in management of patients with thyroid-related upper lid retraction either isolated or associated with proptosis.

Full description

Thyroid Eye Disease (TED) is a complex autoimmune disorder that causes substantial morbidity. It can result in enlargement and scarring of orbital fat and muscles with orbital disfigurement, diplopia, and even vision loss. Although the disease is self-limited following an inflammatory phase of 12 - 18 months, its long-term changes to periocular tissues may have a significant effect on the quality of life, mental health, and socioeconomic status of patients.

Most patients with TED (>90%) have Graves' disease, which is an inflammatory autoimmune condition that is caused by thyrotropin (TSH) receptor autoantibodies. Graves' disease is common around the world and it mainly affects middle-aged women with an overall prevalence of 0.5%.

Several validated assessment scores are used to assess different components of the disease. The two main current TED classifications are from the European Group on Graves Orbitopathy (EUGOGO); and Vision, Inflammation, Strabismus, Appearance (VISA). EUGOGO has introduced one score for clinical activity (CAS) and one for severity "Clinical Severity Score" (CSS). The baseline CAS asses 7 subjective symptoms and inflammatory signs with 3 additional points in follow-up for increased proptosis, decreased ocular motility, or decreased visual acuity (the CAS 10- point scale). In comparison, CSS evaluates the magnitude of the exophthalmometer or proptosis values, lid retraction, diplopia grades, and corneal involvement.

Periorbital inflammation can cause swelling, fatty infiltration, and scarring of the eyelid muscles, resulting in eyelid retraction and upper scleral exposure, which are the most common clinical features of TED.

Several treatment options have been described for correction of eyelid retraction (ELR), including local steroid, Botox and filler injection, and surgeries in the fibrotic stage. Although surgical treatment remains an effective option, the outcomes may be unpredictable. In addition, there are some situations where surgery is inappropriate or contraindicated, where temporary or definitive measures are required during the active phase of the disease, or where patients may prefer less invasive options.

Systemic steroid therapy is a well-established form of immunosuppressive treatment for TED. There have been reports showing promising results with local steroid injection for the treatment of upper eyelid retraction (UER), There are also some reports about the retrobulbar and periocular injection of steroids for management of proptosis in TED.

Enrollment: 92 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical diagnosis of Thyroid Eye Disease.
• Thyroid function within normal range.

Exclusion criteria

• Patients on systemic steroid and or immunosuppressive therapy.
• Patients underwent thyroidectomy.
• Sight threatening (severe) TED which requires immediate surgery.
• Patients with fibrotic ocular muscles who need surgery.
• Contraindications to steroid therapy as in pregnant women.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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92 participants in 4 patient groups

A1 peri-levator betamethasone injection

Experimental group

Description:

patients with isolated thyroid-related upper lid retraction who will be given the Peri-levator injection of betamethasone suspension

Treatment:

Procedure: peri-levator betamethasone injection

A2 Peri-levator triamcinolone acetate injection

Experimental group

Description:

patients with isolated thyroid-related upper lid retraction who will be given Peri-levator injection of triamcinolone acetate

Treatment:

Procedure: peri-levator triamcinolone injection

B1 Peri-levator and retrobulbar betamethasone injection

Experimental group

Description:

patients with thyroid-related upper lid retraction and proptosis who will be given Peri-levator and retrobulbar injection of betamethasone suspension

Treatment:

Procedure: peri-levator and retrobulbar betamethasone injection

B2 Peri-levator and retrobulbar triamcinolone acetate injection

Experimental group

Description:

patients with thyroid-related upper lid retraction and proptosis who will be given Peri-levator and retrobulbar injection of triamcinolone acetate

Treatment:

Procedure: peri-levator and retrobulbar triamcinolone injection