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
Recruitment status was Not yet recruiting
Sponsor:
HaEmek Medical Center, Israel
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
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Purpose
Comparing the effectiveness of subconjunctival and peribulbar Triamcinolone injection to systemic Steroid therapy for patients with active thyroid orbitopathy.
| Condition | Intervention |
|---|---|
|
Thyroid Disease |
Drug: Triamcinolone |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Peribulbar and Subconjunctival Kenalog Injection for Thyroid Orbitopathy |
Resource links provided by NLM:
Genetics Home Reference related topics:
Graves disease
Lenz microphthalmia syndrome
oculofaciocardiodental syndrome
MedlinePlus related topics:
Thyroid Diseases
Drug Information available for:
Triamcinolone diacetate
Triamcinolone acetonide
Triamcinolone
Triamcinolone hexacetonide
U.S. FDA Resources
Further study details as provided by HaEmek Medical Center, Israel:
Primary Outcome Measures:
- 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.
Secondary Outcome Measures:
- 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.
| Estimated Enrollment: | 30 |
| Study Start Date: | February 2011 |
| Estimated Study Completion Date: | February 2013 |
| Estimated Primary Completion Date: | February 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Triamcinolone |
Drug: Triamcinolone
Subconjunctival and peribulbar, 40 mg/ml, 3 monthly injection
Other Name: kenalog
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01280214
Please refer to this study by its ClinicalTrials.gov identifier: NCT01280214
Contacts
| Contact: Daniel Briscoe, MD | 972-4-6494344 | daniel_br@clalit.org.il |
Sponsors and Collaborators
HaEmek Medical Center, Israel
Investigators
| Study Chair: | Daniel Briscoe, MD | haemek medical center |
More Information
| Responsible Party: | Dr Daniel Briscoe, Haemek Medical center |
| ClinicalTrials.gov Identifier: | NCT01280214 History of Changes |
| Other Study ID Numbers: | EMC119710ctil |
| Study First Received: | January 15, 2011 |
| Last Updated: | January 19, 2011 |
| Health Authority: | Israel: Israeli Health Ministry Pharmaceutical Administration |
Additional relevant MeSH terms:
|
Thyroid Diseases Graves Ophthalmopathy Endocrine System Diseases Eye Diseases, Hereditary Eye Diseases Graves Disease Exophthalmos Orbital Diseases Goiter Hyperthyroidism Autoimmune Diseases Immune System Diseases Triamcinolone hexacetonide |
Triamcinolone Triamcinolone Acetonide Triamcinolone diacetate Anti-Inflammatory Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Immunosuppressive Agents Immunologic Factors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on September 27, 2016