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Survey of Patients With Idiopathic Orbital Inflammation Syndrome (SIOI)

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ClinicalTrials.gov Identifier: NCT01443000
Recruitment Status : Completed
First Posted : September 29, 2011
Last Update Posted : April 29, 2019
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief Summary:
The purpose of this study is to characterise the clinical features, histopathology and the treatment outcomes of patients with idiopathic orbital inflammation syndrome.

Condition or disease
Orbital Ischemic Syndrome Orbital Pseudotumor

Detailed Description:
Idiopathic orbital inflammatory syndrome (IOIS) is a heterogeneous group of disorders characterised by orbital inflammation without any identifiable local or systemic causes. It is a rare clinical entity and a diagnosis of exclusion. Lymphomas, thyroid eye diseases or systemic diseases can have similar presentation and so, a histopathological diagnosis is considered important. IOIS is a difficult condition to treat. Compilation of reported small series of patients with IOIS suggested that they require multiple systemic immunosuppressant drugs and radiotherapy. Recently, a large monocentric study including patients with biopsy proven IOIS showed that up to 40% of them can relapse. Their clinical and pathological features did not correlate with treatments outcomes. The investigators decide therefore to conduct a multicentric retro/ prospective study to determine clinical features, histopathology and treatment outcomes of French patients with IOIS.

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Study Type : Observational
Actual Enrollment : 87 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: Survey of Patients With Idiopathic Orbital Inflammation Syndrome (IOIS): Clinical, Morphological and Pathological Features and Treatment Outcomes
Actual Study Start Date : March 3, 2012
Actual Primary Completion Date : June 3, 2017
Actual Study Completion Date : June 3, 2017



Primary Outcome Measures :
  1. Percentage of remission, relapse or resistance among patients with IOIS during the 24 month follow-up [ Time Frame: The remission, relapse, or the resistance at inclusion (for those previously diagnosed as IOIS), and at 6, 12, 18 and 24 months ]

    Remission: absence of steroids, their withdrawal or their pursuit at a dose ≤ 10 mg/d in the absence of immunosuppressor treatment.

    Relapse: re initiation of steroids, or their ascension in patients for whom they have been reduced to less than 20 mg/d.

    Resistance: inability to reduce steroids at an effective dose ≤ 20 mg/d.



Secondary Outcome Measures :
  1. Histopathological classification of IOIS patients [ Time Frame: at diagnostic ]
    -Histopathological forms of the IOIS patients at diagnosis, according to the classification described by Mombaerts, namely: classical orbital pseudotumor, sclerosing orbital pseudotumor, granulomatous orbital pseudotumor and vasculitic pseudotumor.

  2. Ophthalmologic features (laterality, pain, visual acuity, eye movement and eyelid) [ Time Frame: at diagnosis and in case of remission, or relapse, or resistance ]
    The clinical manifestations of systemic diseases mentioned below, will be evaluated in case of relapse or resistance: Grave's disease or auto immune thyroiditis, sarcoidosis, Wegener's granulomatosis, polyarteritis nodosa, Churg- Strauss syndrome, systemic lupus erythematosus and Gougerot-Sjögren syndrome.

  3. MRI features (muscle enlargement, irregular borders, extension to the orbital fat, enhancement around globe) of patients with IOIS [ Time Frame: at diagnosis and in case of remission, or relapse, or resistance. ]
    the lesional topography and the T1/T2 weighted sequences will be studied

  4. Immunologic features of IOIS patients [ Time Frame: at inclusion ]
    the IgG4 level and ANA in sera will be assessed

  5. Cumulated dose of prednisone [ Time Frame: at remission, or relapse, or resistance ]
  6. Incidence of orbital lymphomas [ Time Frame: at 6, 12, 18, 24 months. ]

Biospecimen Retention:   Samples With DNA
Blood samples will be frozen to form a serum storage and a DNAthèque. These samples will achieve further analysis based on the evolution of knowledge on mechanisms contributing to the orbital inflammation.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients followed for IOIS
Criteria

Inclusion Criteria:

  • Patients with biopsy proven IOIS or presumed IOIS
  • Patients with chronic IOS
  • Patient with inaugural IOIS or being treated for IOIS

Exclusion Criteria:

  • Patients who do not fulfill the inclusion criteria
  • Patients with systemic disease-associated IOIS
  • Incomplete follow-up of patients treated for IOIS

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): NCT01443000


Locations
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France
Service de Médecine interne - Hôpital Avicenne
Bobigny, France, 93000
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Ministry of Health, France
Investigators
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Principal Investigator: Sébastien ABAD, MD Assistance Publique - Hôpitaux de Paris

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01443000     History of Changes
Other Study ID Numbers: NI08014
2010-A00512-37 ( Other Identifier: IDRCB )
First Posted: September 29, 2011    Key Record Dates
Last Update Posted: April 29, 2019
Last Verified: April 2019
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Observational study
IOIS
Orbital Pseudotumor
Outcome
Treatment
Additional relevant MeSH terms:
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Orbital Pseudotumor
Syndrome
Inflammation
Disease
Pathologic Processes
Orbital Diseases
Eye Diseases