Intraorbital Injection Versus Oral Steroid in Anterior Idiopathic Orbital Inflammation

Iran University of Medical Sciences

Status and phase: Enrolling; Phase 3

Conditions: Orbital Pseudotumor

Treatments: Drug: Prednisolone; Drug: Triamcinolone + Betamethason

Study type: Interventional

Funder types: Other

Identifiers

NCT03958344

IR.IUMS.REC.1397.1202

Details and patient eligibility

About

A multicenter randomised double-arm clinical trial, to compare safety and efficacy of oral versus intralesional injection of steroid in a group of patients suffering from idiopathic orbital inflammation is designed. Outcome measures include number of recurrences, duration of remission, and side effects.

Full description

Expected to be finished in 3 years, patient enrollment includes 59 patient in each arm of the study. Inclusion criteria consist of clinical and/or imaging evidence of dacryoadenitis with or without adjacent rectus muscles (superior and inferior recti) myositis. Patients meeting following conditions will be excluded:

1. Age < 15 years
2. Diabetes mellitus
3. Collagen Vascular Diseases
4. Vasculitides
5. Biopsy of lacrimal gland denoting a specific diagnosis (i.e. the term "idiopathic" does not apply)
6. Glaucoma
7. Patients who have lost one eye
8. Bilateral disease
9. Abnormal thyroid-stimulating hormone

Outcome measures include number of recurrences, duration of remission, and side effects.

Patient allocation will be based on blocks of 4. Each patient will undergo lacrimal gland biopsy and subsequently will be allocated to one arm of the study according to a predetermined randomization sequence (balanced block of four). Outcome measures will be recorded in 0, 3 and 6 months after patient enrollment.

Patients in oral steroid group will receive 1 mg/kg/day of Prednisolone, tapered in 3 months (based on a detailed table).

Patients in injection group will receive 1 shot of 1 mL (20 mg Triamcinolone + 3 mg Betamethason) into the lacrimal gland.

Enrollment: 120 estimated patients

Sex: All

Ages: 15+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Dacryoadenitis based on clinical findings and/or imaging with and without adjacent recti muscle myositis

Exclusion criteria

• Abnormal thyroid-stimulating hormone
• Systemic Vasculitides
• Bilateral Orbital Inflammation
• Collagen Vascular Diseases
• One Seeing Eye
• Glaucoma
• Diabetes Mellitus

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 2 patient groups

Intraorbital injection of steroid

Experimental group

Description:

2 mL of steroid will be ready for each injection session: 1 mL Triamcinolone (40 mg) + 1 mL Betamethasone (6 mg) = 2 mL For Dacryoadenitis without myositis , 1 mL of this compound will be injected at lacrimal gland through 1 site of injection. For Dacryoadenitis plus 1 rectus muscles myositis 1 mL of this compound will be injected at lacrimal gland and 0.5 mL of this compound will be injected at the rectus muscle through 2 separate sites of injection. For Dacryoadenitis plus 2 rectus muscles myositis 1 mL of this compound will be injected at lacrimal gland and 0.5 mL of this compound will be injected at either recti muscles through 3 separate sites of injection.

Treatment:

Drug: Triamcinolone + Betamethason

Oral Steroid

Active Comparator group

Description:

Each patient will receive oral Prednisolone, 1 mg/kg, for 5-7 days, followed by tapered dose in 12 weeks (according to a pre-defined table of oral administration dose). Daily Omeprazole 40mg p.o and daily Calcium Supplement will also be recommended to avoid complications.

Treatment:

Drug: Prednisolone