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Local Triamcinolone Injection in Active Thyroid Orbitopathy

Primary Purpose

Thyroid Disease

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Triamcinolone
Sponsored by
HaEmek Medical Center, Israel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thyroid Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Triamcinolone

    Arm Description

    Outcomes

    Primary Outcome Measures

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

    To check if the level of TSH Receptor antibodies are affected by the local injection.
    A blood test for TSH Receptor antibodies will be taken for every patient at the beginnig of the research and after 4 months.

    Full Information

    First Posted
    January 15, 2011
    Last Updated
    January 19, 2011
    Sponsor
    HaEmek Medical Center, Israel
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01280214
    Brief Title
    Local Triamcinolone Injection in Active Thyroid Orbitopathy
    Official Title
    Peribulbar and Subconjunctival Kenalog Injection for Thyroid Orbitopathy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2011
    Overall Recruitment Status
    Unknown status
    Study Start Date
    February 2011 (undefined)
    Primary Completion Date
    February 2013 (Anticipated)
    Study Completion Date
    February 2013 (Anticipated)

    3. Sponsor/Collaborators

    Name of the Sponsor
    HaEmek Medical Center, Israel

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Thyroid Disease

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Triamcinolone
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    Triamcinolone
    Other Intervention Name(s)
    kenalog
    Intervention Description
    Subconjunctival and peribulbar, 40 mg/ml, 3 monthly injection
    Primary Outcome Measure Information:
    Title
    Comparing the effectiveness of subconjunctival and peribulbar Triamcinolone injection to systemic Steroid therapy for patients with active thyroid orbitopathy .
    Description
    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.
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    To check if the level of TSH Receptor antibodies are affected by the local injection.
    Description
    A blood test for TSH Receptor antibodies will be taken for every patient at the beginnig of the research and after 4 months.
    Time Frame
    4 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Daniel Briscoe, MD
    Phone
    972-4-6494344
    Email
    daniel_br@clalit.org.il
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Daniel Briscoe, MD
    Organizational Affiliation
    haemek medical center
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

    Local Triamcinolone Injection in Active Thyroid Orbitopathy

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