Orbital PseudotumorPhase 3NCT03958344
Intraorbital Injection Versus Oral Steroid in Anterior Idiopathic Orbital Inflammation
A Phase 3 study testing Prednisolone and Triamcinolone + Betamethason in people with Orbital Pseudotumor, run by Iran University of Medical Sciences at 1 site in Iran.
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. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Orbital Pseudotumor
- What is being tested?
- Prednisolone and Triamcinolone + Betamethason
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteIran
- Study dates
- 1 Jan 2022to 1 Jun 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Dacryoadenitis based on clinical findings and/or imaging with and without adjacent recti muscle myositis
Who cannot join
- Abnormal thyroid-stimulating hormone
- Systemic Vasculitides
- Bilateral Orbital Inflammation
- Collagen Vascular Diseases
- One Seeing Eye
- Glaucoma
- Diabetes Mellitus
Trial locations and contacts
1 site in 1 country.
Iran1 site, 1 recruiting
- Recruiting
Iran University of Medical Sciences
Tehrān, Tehran Province
Mohsen B Kashkouli, MD, 0098 912 1777003, mkashkouli2@gmail.com
About this study
Official title: Intraorbital Injection Versus Oral Steroid in Patients With Anterior Idiopathic Orbital Inflammation: A Randomized Clinical Trial
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.
Read the 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.
- Conditions
- Orbital Pseudotumor
- Being tested
- Prednisolone, Triamcinolone + Betamethason
- Medical subject headings
- Orbital Pseudotumor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrednisoloneDrug
Also called Oral Prednisolone
Oral Tablet
Triamcinolone + BetamethasonDrug
Also called Injectable Steroid
A compound long acting and short acting injectable steroid
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Prednisolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence number
frequency of occurrence of clinical condition showing signs of inflammation recurrence, during or after cessation of steroid therapy
Measured: 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
Measured: up to 6 months
Adverse Effect
Any significant ocular or systemic side effect reported by the patient or found in examination sessions
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2019
- Study start1 Jan 2022
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Orbital PseudotumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized parallel double arm
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Iran University of Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Tehran University of Medical Sciences, Mashhad University of Medical Sciences, Shahid Beheshti University of Medical Sciences
- Responsible party
- Sponsor
- Investigators
- Mohsen B Kashkouli, MD, Principal investigator, Iran University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03958344
- Sponsor's protocol ID
- IR.IUMS.REC.1397.1202
- Status last verified
- Feb 2023
- First submitted
- 7 May 2019
- Last updated
- 16 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 17620331Bijlsma 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.
PubMed 21349945El 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.
PubMed 23839634Leibovitch 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.
PubMed 18071116Reggie 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.
PubMed 28872378
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraorbital Injection Versus Oral Steroid in Patients With Anterior Idiopathic Orbital Inflammation: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03958344
- Acronym / sponsor ID
- IR.IUMS.REC.1397.1202
- Conditions
- Orbital Pseudotumor
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Iran University of Medical SciencesUniversity, hospital or other
- Collaborators
- Tehran University of Medical Sciences, Mashhad University of Medical Sciences, Shahid Beheshti University of Medical Sciences
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 22 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized parallel double arm
| Arm | Type | Receives |
|---|---|---|
| Intraorbital injection of steroid | Experimental | Drug: Triamcinolone + Betamethason2 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. |
| Oral Steroid | Active comparator | Drug: PrednisoloneEach 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. |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Dacryoadenitis based on clinical findings and/or imaging with and without adjacent recti muscle myositis
Key exclusion criteria (7 listed)
- Abnormal thyroid-stimulating hormone
- Systemic Vasculitides
- Bilateral Orbital Inflammation
- Collagen Vascular Diseases
- One Seeing Eye
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PrednisoloneAlso: Oral PrednisoloneOral Tablet | Drug | Oral Steroid |
| Triamcinolone + BetamethasonAlso: Injectable SteroidA compound long acting and short acting injectable steroid | Drug | Intraorbital injection of steroid |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2023.
- Background: PubMed 17620331Swamy 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.
- Background: PubMed 21349945Bijlsma 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.
- Results publication: PubMed 23839634El 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.
- Results publication: PubMed 18071116Leibovitch 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.
- Results publication: PubMed 28872378Reggie 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohsen B Kashkouli, MD principal investigator
Iran University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Prednisolone and Triamcinolone + Betamethason in people with Orbital Pseudotumor, run by Iran University of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohsen B Kashkouli, MD (00989121777003, mkashkouli2@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence number (time frame: up to 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03958344, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2023.