Intraorbital Injection Versus Oral Steroid in Anterior Idiopathic Orbital Inflammation

Orbital Pseudotumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03958344
• Other study ID #: IR.IUMS.REC.1397.1202
• Status: Recruiting
• Phase: Phase 3
• Start date: January 1, 2022
• Est. completion date: June 1, 2025

Study information

• Verified date: February 2023
• Source: Iran University of Medical Sciences
• Contact: Mohsen B Kashkouli, MD
• Phone: 00989121777003
• Email: mkashkouli2[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: June 1, 2025
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Inflammation
• Orbital Pseudotumor

Intervention

Drug:
• Prednisolone
Oral Tablet
• Triamcinolone + Betamethason
A compound long acting and short acting injectable steroid

Locations

Country	Name	City	State
Iran, Islamic Republic of	Iran University of Medical Sciences	Tehran	Tehran

Sponsors (4)

Lead Sponsor	Collaborator
Iran University of Medical Sciences	Mashhad University of Medical Sciences, Shahid Beheshti University of Medical Sciences, Tehran University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

References & Publications (5)

Bijlsma WR, Paridaens D, Kalmann R. Treatment of severe idiopathic orbital inflammation with intravenous methylprednisolone. Br J Ophthalmol. 2011 Aug;95(8):1068-71. doi: 10.1136/bjo.2010.195552. Epub 2011 Feb 24. — View Citation

El Nasser A Mohammad A. Local steroid injection for management of different types of acute idiopathic orbital inflammation: an 8-year study. Ophthalmic Plast Reconstr Surg. 2013 Jul-Aug;29(4):286-9. doi: 10.1097/IOP.0b013e318293750c. — View Citation

Leibovitch I, Prabhakaran VC, Davis G, Selva D. Intraorbital injection of triamcinolone acetonide in patients with idiopathic orbital inflammation. Arch Ophthalmol. 2007 Dec;125(12):1647-51. doi: 10.1001/archopht.125.12.1647. — View Citation

Reggie S, Neimkin M, Holds J. Intralesional corticosteroid injections as treatment for non-infectious orbital inflammation. Orbit. 2018 Feb;37(1):41-47. doi: 10.1080/01676830.2017.1353110. Epub 2017 Sep 5. — View Citation

Swamy BN, McCluskey P, Nemet A, Crouch R, Martin P, Benger R, Ghabriel R, Wakefield D. Idiopathic orbital inflammatory syndrome: clinical features and treatment outcomes. Br J Ophthalmol. 2007 Dec;91(12):1667-70. doi: 10.1136/bjo.2007.124156. Epub 2007 Jul 9. — View Citation

Outcome

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