NCT01280214

Brief Summary

Comparing the effectiveness of subconjunctival and peribulbar Triamcinolone injection to systemic Steroid therapy for patients with active thyroid orbitopathy.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2011

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 15, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 20, 2011

Completed
12 days until next milestone

Study Start

First participant enrolled

February 1, 2011

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
Last Updated

January 20, 2011

Status Verified

January 1, 2011

Enrollment Period

2 years

First QC Date

January 15, 2011

Last Update Submit

January 19, 2011

Conditions

Thyroid Disease

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • To check if the level of TSH Receptor antibodies are affected by the local injection.

    4 months

Study Arms (1)

Triamcinolone

EXPERIMENTAL
Drug: Triamcinolone

Interventions

TriamcinoloneDRUG

Subconjunctival and peribulbar, 40 mg/ml, 3 monthly injection

Also known as: kenalog
Triamcinolone

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age\>18 years.
  • Active thyroid orbitopathy according to clinical activity score\>=3.

You may not qualify if:

  • Intraorbital or active infections.
  • Tuberculosis.
  • Other orbital disease.
  • Pregnancy.
  • Compressive optic neuropathy.
  • Systemic steroid therapy within 6 months of study start.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Thyroid Diseases

Interventions

TriamcinoloneTriamcinolone Acetonide

Condition Hierarchy (Ancestors)

Endocrine System Diseases

Intervention Hierarchy (Ancestors)

PregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Officials

  • Daniel Briscoe, MD

    haemek medical center

    STUDY CHAIR

Central Study Contacts

Daniel Briscoe, MD

CONTACT

972-4-6494344daniel_br@clalit.org.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 15, 2011

First Posted

January 20, 2011

Study Start

February 1, 2011

Primary Completion

February 1, 2013

Study Completion

February 1, 2013

Last Updated

January 20, 2011

Record last verified: 2011-01