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Local Triamcinolone Injection in Active Thyroid Orbitopathy

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2011 by HaEmek Medical Center, Israel.
Recruitment status was:  Not yet recruiting
Information provided by:
HaEmek Medical Center, Israel Identifier:
First received: January 15, 2011
Last updated: January 19, 2011
Last verified: January 2011
Comparing the effectiveness of subconjunctival and peribulbar Triamcinolone injection to systemic Steroid therapy for patients with active thyroid orbitopathy.

Condition Intervention
Thyroid Disease Drug: Triamcinolone

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Peribulbar and Subconjunctival Kenalog Injection for Thyroid Orbitopathy

Resource links provided by NLM:

Further study details as provided by HaEmek Medical Center, Israel:

Primary Outcome Measures:
  • 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:
  • 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.

Estimated Enrollment: 30
Study Start Date: February 2011
Estimated Study Completion Date: February 2013
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Triamcinolone Drug: Triamcinolone
Subconjunctival and peribulbar, 40 mg/ml, 3 monthly injection
Other Name: kenalog

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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
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Please refer to this study by its identifier: NCT01280214

Contact: Daniel Briscoe, MD 972-4-6494344

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

Responsible Party: Dr Daniel Briscoe, Haemek Medical center Identifier: NCT01280214     History of Changes
Other Study ID Numbers: EMC119710ctil
Study First Received: January 15, 2011
Last Updated: January 19, 2011

Additional relevant MeSH terms:
Thyroid Diseases
Graves Ophthalmopathy
Endocrine System Diseases
Eye Diseases, Hereditary
Eye Diseases
Graves Disease
Orbital Diseases
Autoimmune Diseases
Immune System Diseases
Triamcinolone hexacetonide
Triamcinolone Acetonide
Triamcinolone diacetate
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on September 20, 2017