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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT01280214
Other study ID # EMC119710ctil
Secondary ID
Status Not yet recruiting
Phase N/A
First received January 15, 2011
Last updated January 19, 2011
Start date February 2011
Est. completion date February 2013

Study information

Verified date January 2011
Source HaEmek Medical Center, Israel
Contact Daniel Briscoe, MD
Phone 972-4-6494344
Email daniel_br@clalit.org.il
Is FDA regulated No
Health authority Israel: Israeli Health Ministry Pharmaceutical Administration
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 30
Est. completion date February 2013
Est. primary completion date February 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Triamcinolone
Subconjunctival and peribulbar, 40 mg/ml, 3 monthly injection

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
HaEmek Medical Center, Israel

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
6 months Yes
Secondary 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. 4 months Yes
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