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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

January 15, 2011
January 19, 2011
February 2011
February 2013   (final data collection date for primary outcome measure)
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.

Same as current
Complete list of historical versions of study NCT01280214 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Local Triamcinolone Injection in Active Thyroid Orbitopathy
Peribulbar and Subconjunctival Kenalog Injection for Thyroid Orbitopathy

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

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.

Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Thyroid Disease
Drug: Triamcinolone
Subconjunctival and peribulbar, 40 mg/ml, 3 monthly injection
Other Name: kenalog
Experimental: Triamcinolone
Intervention: Drug: Triamcinolone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
30
February 2013
February 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Daniel Briscoe, MD 972-4-6494344 daniel_br@clalit.org.il
Not Provided
 
NCT01280214
EMC119710ctil
Yes
Dr Daniel Briscoe, Haemek Medical center
HaEmek Medical Center, Israel
Not Provided
Study Chair: Daniel Briscoe, MD Haemek medical center
HaEmek Medical Center, Israel
January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP