Local Triamcinolone Injection in Active Thyroid Orbitopathy
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ClinicalTrials.gov Identifier: NCT01280214 |
Recruitment Status : Unknown
Verified January 2011 by HaEmek Medical Center, Israel.
Recruitment status was: Not yet recruiting
First Posted : January 20, 2011
Last Update Posted : January 20, 2011
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Thyroid Disease | Drug: Triamcinolone | Not Applicable |
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 (Clinical Trial) |
Estimated Enrollment : | 30 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Peribulbar and Subconjunctival Kenalog Injection for Thyroid Orbitopathy |
Study Start Date : | February 2011 |
Estimated Primary Completion Date : | February 2013 |
Estimated Study Completion Date : | February 2013 |

Arm | Intervention/treatment |
---|---|
Experimental: Triamcinolone |
Drug: Triamcinolone
Subconjunctival and peribulbar, 40 mg/ml, 3 monthly injection
Other Name: kenalog |
- 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.
- 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.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01280214
Contact: Daniel Briscoe, MD | 972-4-6494344 | daniel_br@clalit.org.il |
Study Chair: | Daniel Briscoe, MD | haemek medical center |
Responsible Party: | Dr Daniel Briscoe, Haemek Medical center |
ClinicalTrials.gov Identifier: | NCT01280214 |
Other Study ID Numbers: |
EMC119710ctil |
First Posted: | January 20, 2011 Key Record Dates |
Last Update Posted: | January 20, 2011 |
Last Verified: | January 2011 |
Graves Ophthalmopathy Thyroid Diseases Endocrine System Diseases Eye Diseases, Hereditary Eye Diseases Graves Disease Exophthalmos Orbital Diseases Genetic Diseases, Inborn Goiter |
Hyperthyroidism Autoimmune Diseases Immune System Diseases Triamcinolone Anti-Inflammatory Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs |