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Local Triamcinolone Injection in Active Thyroid Orbitopathy

Sponsor
HaEmek Medical Center, Israel (Other)
Overall Status
Unknown status
CT.gov ID
NCT01280214
Collaborator
(none)
30
Enrollment
1
Arm
24
Duration (Months)

Study Details

Study Description

Brief Summary

Comparing the effectiveness of subconjunctival and peribulbar Triamcinolone injection to systemic Steroid therapy for patients with active thyroid orbitopathy.

Condition or Disease Intervention/Treatment Phase
N/A

Detailed Description

Local Steroid treatment may help in active thyroid orbitopathy. till today, systemic Steroids are the treatment for active thyroid orbitopathy which is associated with systemic adverse effects.

In this study the investigators want to compare the effectiveness of local Triamcinolone therapy for active thyroid orbitopathy.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Peribulbar and Subconjunctival Kenalog Injection for Thyroid Orbitopathy
Study Start Date :
Feb 1, 2011
Anticipated Primary Completion Date :
Feb 1, 2013
Anticipated Study Completion Date :
Feb 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Experimental: Triamcinolone

Drug: Triamcinolone
Subconjunctival and peribulbar, 40 mg/ml, 3 monthly injection
Other Names:
  • kenalog

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Comparing the effectiveness of subconjunctival and peribulbar Triamcinolone injection to systemic Steroid therapy for patients with active thyroid orbitopathy . [6 months]

      Every month, each participant will undergo several tests : blood sugar, full ocular examination, color test, visual field and ultrasound test for measuring the thickness of extraocular muscles.Clinical activity score for thyroid orbitopathy will be assesed too. The results of the clinical and ultrasonogrophic findings will determine the effectiveness of the treatment. A patient with deterioration of thyroid orbitopathy during the research, will be treated by systemic Steroids in addition to the local injections.

    Secondary Outcome Measures

    1. To check if the level of TSH Receptor antibodies are affected by the local injection. [4 months]

      A blood test for TSH Receptor antibodies will be taken for every patient at the beginnig of the research and after 4 months.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Age>18 years.

    • Active thyroid orbitopathy according to clinical activity score>=3.

    Exclusion Criteria:

    • Intraorbital or active infections.

    • Tuberculosis.

    • Other orbital disease.

    • Pregnancy.

    • Compressive optic neuropathy.

    • Systemic steroid therapy within 6 months of study start.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • HaEmek Medical Center, Israel

    Investigators

    • Study Chair: Daniel Briscoe, MD, haemek medical center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01280214
    Other Study ID Numbers:
    • EMC119710ctil
    First Posted:
    Jan 20, 2011
    Last Update Posted:
    Jan 20, 2011
    Last Verified:
    Jan 1, 2011
    Additional relevant MeSH terms:
    Graves Ophthalmopathy
    Thyroid Diseases
    Triamcinolone

    Study Results

    No Results Posted as of Jan 20, 2011