Text Size

Local Triamcinolone Injection in Active Thyroid Orbitopathy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by HaEmek Medical Center, Israel.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier:
NCT01280214
First received: January 15, 2011
Last updated: January 19, 2011
Last verified: January 2011
History of Changes
  Purpose

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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Peribulbar and Subconjunctival Kenalog Injection for Thyroid Orbitopathy

Resource links provided by NLM:

MedlinePlus related topics: Thyroid Diseases
U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]

    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 ] [ Designated as safety issue: Yes ]
    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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Dr Daniel Briscoe, Haemek Medical center
ClinicalTrials.gov Identifier: NCT01280214     History of Changes
Other Study ID Numbers: EMC119710ctil
Study First Received: January 15, 2011
Last Updated: January 19, 2011
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

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
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2013