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
About this trial
This is an interventional treatment trial for Thyroid Disease
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.
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
NCT ID
NCT01280214
First Posted
January 15, 2011
Last Updated
January 19, 2011
Sponsor
HaEmek Medical Center, Israel
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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