Local Triamcinolone Injection in Active Thyroid Orbitopathy

Thyroid Disease Clinical Trial

Official title:

Peribulbar and Subconjunctival Kenalog Injection for Thyroid Orbitopathy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01280214
• Other study ID #: EMC119710ctil
• 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

• Graves Ophthalmopathy
• Thyroid Disease
• Thyroid Diseases

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