Intraorbital Injection Versus Oral Steroid in Anterior Idiopathic Orbital Inflammation
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|ClinicalTrials.gov Identifier: NCT03958344|
Recruitment Status : Not yet recruiting
First Posted : May 22, 2019
Last Update Posted : May 22, 2019
|Condition or disease||Intervention/treatment||Phase|
|Orbital Pseudotumor||Drug: Prednisolone Drug: Triamcinolone + Betamethason||Phase 3|
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
- Biopsy of lacrimal gland denoting a specific diagnosis (i.e. the term "idiopathic" does not apply)
- 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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomized parallel double arm|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Official Title:||Intraorbital Injection Versus Oral Steroid in Patients With Anterior Idiopathic Orbital Inflammation: A Randomized Clinical Trial|
|Estimated Study Start Date :||June 1, 2019|
|Estimated Primary Completion Date :||June 1, 2022|
|Estimated Study Completion Date :||June 1, 2023|
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 Name: 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.
Other Name: Oral Prednisolone
- Recurrence number [ Time Frame: up to 6 months ]frequency of occurrence of clinical condition showing signs of inflammation recurrence, during or after cessation of steroid therapy
- Recurrence time [ Time Frame: 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 [ Time Frame: up to 6 months ]Any significant ocular or systemic side effect reported by the patient or found in examination sessions
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03958344
|Contact: Mohsen B Kashkouli, MDfirstname.lastname@example.org|
|Contact: Nasser Karimi, MDemail@example.com|
|Iran, Islamic Republic of|
|Iran University of Medical Sciences|
|Tehrān, Tehran, Iran, Islamic Republic of|
|Principal Investigator:||Mohsen B Kashkouli, MD||Iran University of Medical Sciences|