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Local Triamcinolone Injection in Active Thyroid Orbitopathy

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ClinicalTrials.gov Identifier: NCT01280214
Recruitment Status : Unknown
Verified January 2011 by HaEmek Medical Center, Israel.
Recruitment status was:  Not yet recruiting
First Posted : January 20, 2011
Last Update Posted : January 20, 2011
Sponsor:
Information provided by:

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
Thyroid Disease Drug: Triamcinolone

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  (Clinical Trial)
Estimated Enrollment : 30 participants
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 : February 2011
Estimated Primary Completion Date : February 2013
Estimated Study Completion Date : February 2013


Arms and Interventions

Arm Intervention/treatment
Experimental: Triamcinolone Drug: Triamcinolone
Subconjunctival and peribulbar, 40 mg/ml, 3 monthly injection
Other Name: 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 . [ Time Frame: 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. [ Time Frame: 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

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations

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): NCT01280214


Contacts
Contact: Daniel Briscoe, MD 972-4-6494344 daniel_br@clalit.org.il

Sponsors and Collaborators
HaEmek Medical Center, Israel
Investigators
Study Chair: Daniel Briscoe, MD haemek medical center
More Information

Responsible Party: Dr Daniel Briscoe, Haemek Medical center
ClinicalTrials.gov Identifier: NCT01280214     History of Changes
Other Study ID Numbers: EMC119710ctil
First Posted: January 20, 2011    Key Record Dates
Last Update Posted: January 20, 2011
Last Verified: January 2011

Additional relevant MeSH terms:
Thyroid Diseases
Graves Ophthalmopathy
Endocrine System Diseases
Eye Diseases, Hereditary
Eye Diseases
Graves Disease
Exophthalmos
Orbital Diseases
Goiter
Hyperthyroidism
Autoimmune Diseases
Immune System Diseases
Triamcinolone hexacetonide
Triamcinolone
Triamcinolone Acetonide
Triamcinolone diacetate
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action