Local Triamcinolone Injection in Active Thyroid Orbitopathy

January 19, 2011 updated by: HaEmek Medical Center, Israel

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Triamcinolone
Drug: Triamcinolone
Subconjunctival and peribulbar, 40 mg/ml, 3 monthly injection
Other Names:
  • kenalog

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

HaEmek Medical Center, Israel

Investigators

  • Study Chair: Daniel Briscoe, MD, HaEmek Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (Anticipated)

February 1, 2013

Study Completion (Anticipated)

February 1, 2013

Study Registration Dates

First Submitted

January 15, 2011

First Submitted That Met QC Criteria

January 19, 2011

First Posted (Estimate)

January 20, 2011

Study Record Updates

Last Update Posted (Estimate)

January 20, 2011

Last Update Submitted That Met QC Criteria

January 19, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EMC119710ctil

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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