Intraorbital Injection Versus Oral Steroid in Anterior Idiopathic Orbital Inflammation

Sponsor

Iran University of Medical Sciences (Other)

Overall Status

Recruiting

CT.gov ID

NCT03958344

Collaborator

Tehran University of Medical Sciences (Other), Mashhad University of Medical Sciences (Other), Shahid Beheshti University of Medical Sciences (Other)

120

Enrollment

Location

Arms

Anticipated Duration (Months)

6.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Orbital Pseudotumor	Drug: Prednisolone Drug: Triamcinolone + Betamethason	Phase 3

Detailed 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:

Age < 15 years
Diabetes mellitus
Collagen Vascular Diseases
Vasculitides
Biopsy of lacrimal gland denoting a specific diagnosis (i.e. the term "idiopathic" does not apply)
Glaucoma
Patients who have lost one eye
Bilateral disease
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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomized parallel double armRandomized parallel double arm

Masking:

Double (Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Intraorbital Injection Versus Oral Steroid in Patients With Anterior Idiopathic Orbital Inflammation: A Randomized Clinical Trial

Anticipated Study Start Date :

Dec 1, 2021

Anticipated Primary Completion Date :

Jun 1, 2022

Anticipated Study Completion Date :

Jun 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intraorbital injection of steroid 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.	Drug: Triamcinolone + Betamethason A compound long acting and short acting injectable steroid Other Names: Injectable Steroid
Active Comparator: Oral Steroid 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.	Drug: Prednisolone Oral Tablet Other Names: Oral Prednisolone

Arm

Intervention/Treatment

Experimental: Intraorbital injection of steroid

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.

Drug: Triamcinolone + Betamethason

A compound long acting and short acting injectable steroid

Other Names:

Injectable Steroid

Active Comparator: Oral Steroid

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.

Drug: Prednisolone

Oral Tablet

Other Names:

Oral Prednisolone

Outcome Measures

Primary Outcome Measures

Recurrence number [up to 6 months]
frequency of occurrence of clinical condition showing signs of inflammation recurrence, during or after cessation of steroid therapy
Recurrence time [up to 6 months]
mean time of occurrence of clinical condition showing signs of inflammation recurrence, during or after cessation of steroid therapy
Adverse Effect [up to 6 months]
Any significant ocular or systemic side effect reported by the patient or found in examination sessions