Thyroid DiseaseNCT01280214
Local Triamcinolone Injection in Active Thyroid Orbitopathy
A study testing Triamcinolone in people with Thyroid Disease, run by HaEmek Medical Center, Israel.
Trial summary
Comparing the effectiveness of subconjunctival and peribulbar Triamcinolone injection to systemic Steroid therapy for patients with active thyroid orbitopathy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thyroid Disease
- What is being tested?
- Triamcinolone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Feb 2011to Feb 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age>18 years.
- Active thyroid orbitopathy according to clinical activity score>=3.
Who cannot join
- Intraorbital or active infections.
- Tuberculosis.
- Other orbital disease.
- Pregnancy.
- Compressive optic neuropathy.
- Systemic steroid therapy within 6 months of study start.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Conditions
- Thyroid Disease
- Being tested
- Triamcinolone
- Medical subject headings
- Thyroid Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TriamcinoloneDrug
Also called kenalog
Subconjunctival and peribulbar, 40 mg/ml, 3 monthly injection
| Study group | Role | What they receive |
|---|---|---|
| Triamcinolone | Experimental | Not described Receives: Drug: Triamcinolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (1)
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.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2011 (estimated)
- Study startFeb 2011
- Primary completionFeb 2013 (estimated)
- Study completionFeb 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HaEmek Medical Center, Israel
- Sponsor type
- University, hospital or other
- Investigators
- Daniel Briscoe, MD, Study chair, haemek medical center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01280214
- Sponsor's protocol ID
- EMC119710ctil
- Status last verified
- Jan 2011
- First submitted
- 15 Jan 2011
- Last updated
- 20 Jan 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peribulbar and Subconjunctival Kenalog Injection for Thyroid Orbitopathy
- ClinicalTrials.gov ID
- NCT01280214
- Acronym / sponsor ID
- EMC119710ctil
- Conditions
- Thyroid Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- HaEmek Medical Center, IsraelUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Feb 2013 (estimated)
- Study completion
- Feb 2013 (estimated)
- First posted
- 20 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Comparing the effectiveness of subconjunctival and peribulbar Triamcinolone injection to systemic Steroid therapy for patients with active thyroid orbitopathy.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Triamcinolone | Experimental | Drug: Triamcinolone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age>18 years.
- Active thyroid orbitopathy according to clinical activity score>=3.
Key exclusion criteria (6 listed)
- Intraorbital or active infections.
- Tuberculosis.
- Other orbital disease.
- Pregnancy.
- Compressive optic neuropathy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TriamcinoloneAlso: kenalogSubconjunctival and peribulbar, 40 mg/ml, 3 monthly injection | Drug | Triamcinolone |
Primary outcome
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.
1 secondary outcome
To check if the level of TSH Receptor antibodies are affected by the local injection.
Time frame: 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Briscoe, MD study chair
haemek medical center
Questions about this trial
What is this clinical trial studying?
A study testing Triamcinolone in people with Thyroid Disease, run by HaEmek Medical Center, Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Daniel Briscoe, MD (972-4-6494344, daniel_br@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparing the effectiveness of subconjunctival and peribulbar Triamcinolone injection to systemic Steroid therapy for patients with active thyroid orbitopathy . (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2011.