Intraorbital Injection Versus Oral Steroid in Anterior Idiopathic Orbital Inflammation

NCT03958344 | Unknown Phase 3

• 1 other identifier: IR.IUMS.REC.1397.1202
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Orbital Pseudotumor

Outcome Measures

Primary Outcomes (3)

• Recurrence number

  frequency of occurrence of clinical condition showing signs of inflammation recurrence, during or after cessation of steroid therapy

  up to 6 months

• 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

• Adverse Effect

  Any significant ocular or systemic side effect reported by the patient or found in examination sessions

  up to 6 months

Study Arms (2)

Intraorbital injection of steroid

EXPERIMENTAL

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

Oral Steroid

ACTIVE COMPARATOR

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

Interventions

Prednisolone DRUG

Oral Tablet

Also known as: Oral Prednisolone

Oral Steroid

Triamcinolone + Betamethason DRUG

A compound long acting and short acting injectable steroid

Also known as: Injectable Steroid

Intraorbital injection of steroid

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Iran University of Medical Sciences: lead
• Tehran University of Medical Sciences: collaborator
• Mashhad University of Medical Sciences: collaborator
• Shahid Beheshti University of Medical Sciences: collaborator

Study Sites (1)

Iran University of Medical Sciences

Tehrān, Tehran Province, Iran

RECRUITING

Related Publications (5)

• 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.

  PMID: 17620331 BACKGROUND

• 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.

  PMID: 21349945 BACKGROUND

• 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.

  PMID: 23839634 RESULT

• 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.

  PMID: 18071116 RESULT

• 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.

  PMID: 28872378 RESULT

MeSH Terms

Conditions

Orbital Pseudotumor

Interventions

Prednisolone; Triamcinolone

Condition Hierarchy (Ancestors)

Orbital Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Mohsen B Kashkouli, MD

  Iran University of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohsen B Kashkouli, MD

CONTACT

00989121777003; mkashkouli2@gmail.com

Nasser Karimi, MD

CONTACT

+989123272376; karimi.na@iums.ac.ir

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized parallel double arm

Study Record Dates

• First Submitted: May 7, 2019
• First Posted: May 22, 2019
• Study Start: January 1, 2022
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2025
• Last Updated: February 16, 2023

Record last verified: 2023-02

Locations

IR (1)