- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00430547
Thyroid-Associated Ophthalmopathy Subtypes and Orbital Antibodies
February 1, 2007 updated by: Barwon Health
The purpose of this study is to determine whether radioactive iodine, as compared to anti-thyroid medications, is a risk factor for the development or progression of thyroid-associated ophthalmopathy in patients with hyperthyroidism due to Graves' disease.
The other aim of this study is to determine the incidence of the various ophthalmopathy subtypes and the utility of orbital antibodies in the diagnosis, classification and monitoring of patients with thyroid-associated ophthalmopathy.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment
60
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.
Study Locations
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Victoria
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Geelong, Victoria, Australia, 3220
- Barwon Health - The Geelong Hospital
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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:
- Graves' disease diagnosed in the last 3 months, regardless of the presence of ophthalmopathy
Exclusion Criteria:
- Pre-existing eye disease: e.g. orbital surgery, orbital irradiation or significant loss of vision
- Age < 18 years
- Inability to consent to participation in the study
- Pregnancy
- History of radio-active iodine therapy
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: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Onset or progression of ophthalmopathy following radio-active iodine therapy
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jack R Wall, BMBS, FRACP, PhD, University of Sydney
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
August 1, 2003
Study Completion
January 1, 2006
Study Registration Dates
First Submitted
February 1, 2007
First Submitted That Met QC Criteria
February 1, 2007
First Posted (Estimate)
February 2, 2007
Study Record Updates
Last Update Posted (Estimate)
February 2, 2007
Last Update Submitted That Met QC Criteria
February 1, 2007
Last Verified
August 1, 2003
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Immune System Diseases
- Autoimmune Diseases
- Endocrine System Diseases
- Genetic Diseases, Inborn
- Thyroid Diseases
- Eye Diseases, Hereditary
- Graves Disease
- Exophthalmos
- Orbital Diseases
- Goiter
- Hyperthyroidism
- Eye Diseases
- Graves Ophthalmopathy
- Physiological Effects of Drugs
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Hormone Antagonists
- Antithyroid Agents
- Carbimazole
Other Study ID Numbers
- 03/53
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.
Clinical Trials on Graves' Ophthalmopathy
-
Medical University of ViennaUnknownGraves Ophthalmopathy | Graves Disease | Graves' Ophthalmopathy WorsenedAustria
-
University of Sao PauloCompletedGraves' Ophthalmopathy | Graves' DiseaseBrazil
-
Odense University HospitalCompletedThyroid Associated Ophthalmopathy | Graves´ DiseaseDenmark
-
Sun Yat-sen UniversityRecruitingImmune System Diseases | Autoimmune Diseases | Endocrine System Diseases | Thyroid Diseases | Eye Diseases, Hereditary | Graves Ophthalmopathy | Graves Disease | Hyperthyroidism | Thyroid-associated OphthalmopathyChina
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Ankara UniversityUnknownGraves' OphthalmopathyTurkey
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Yonsei UniversityUnknownMild Graves' OphthalmopathyKorea, Republic of
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Sun Yat-sen UniversityUnknownGraves' OphthalmopathyChina
-
Ruijin HospitalUnknown
-
National Taiwan University HospitalUnknownGraves' OphthalmopathyTaiwan
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Silkiss, Rona Z., M.D., FACSLauer, Simeon, M.D.; Reier, Alice M.D.; Coleman, Morton M.D.CompletedThyroid Related Orbitopathy | Graves' Dysthyroid OphthalmopathyUnited States
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-
University of MinnesotaCompleted
-
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Attabib, Najmedden, M.D.Terminated
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Fred Hutchinson Cancer CenterNational Cancer Institute (NCI)CompletedExtranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue | Nodal Marginal Zone B-cell Lymphoma | Recurrent Adult Burkitt Lymphoma | Recurrent Adult Diffuse Large Cell Lymphoma | Recurrent Adult Diffuse Mixed Cell Lymphoma | Recurrent Adult Diffuse Small Cleaved Cell Lymphoma and other conditionsUnited States
-
University of California, Los AngelesLundquist Institute for Biomedical Innovation at Harbor-UCLA Medical CenterTerminated
-
National University Hospital, SingaporeCompleted