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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 : August 6, 2019
Sponsor:
Collaborators:
Tehran University of Medical Sciences
Mashhad University of Medical Sciences
Shahid Beheshti University of Medical Sciences
Information provided by (Responsible Party):
Iran University of Medical Sciences

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:

  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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized 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
Estimated Study Start Date : November 1, 2019
Estimated Primary Completion Date : June 1, 2022
Estimated Study Completion Date : June 1, 2023


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 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.

Drug: Prednisolone
Oral Tablet
Other Name: Oral Prednisolone




Primary Outcome Measures :
  1. 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

  2. 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

  3. Adverse Effect [ Time Frame: up to 6 months ]
    Any significant ocular or systemic side effect reported by the patient or found in examination sessions



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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Mohsen B Kashkouli, MD 00989121777003 mkashkouli2@gmail.com
Contact: Nasser Karimi, MD +989123272376 karimi.na@iums.ac.ir

Locations
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Iran, Islamic Republic of
Iran University of Medical Sciences
Tehrān, Tehran, Iran, Islamic Republic of
Sponsors and Collaborators
Iran University of Medical Sciences
Tehran University of Medical Sciences
Mashhad University of Medical Sciences
Shahid Beheshti University of Medical Sciences
Investigators
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Principal Investigator: Mohsen B Kashkouli, MD Iran University of Medical Sciences

Publications of Results:
Other Publications:
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Responsible Party: Iran University of Medical Sciences
ClinicalTrials.gov Identifier: NCT03958344     History of Changes
Other Study ID Numbers: IR.IUMS.REC.1397.1202
First Posted: May 22, 2019    Key Record Dates
Last Update Posted: August 6, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Orbital Pseudotumor
Inflammation
Pathologic Processes
Orbital Diseases
Eye Diseases
Prednisolone
Methylprednisolone Acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone acetate
Triamcinolone
Triamcinolone Acetonide
Triamcinolone hexacetonide
Prednisolone hemisuccinate
Prednisolone phosphate
Triamcinolone diacetate
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents
Immunosuppressive Agents