Thyroid-Associated Ophthalmopathy Subtypes and Orbital Antibodies

This study has been completed.

Sponsors and Collaborators:	Barwon Health University of Melbourne National Health and Medical Research Council, Australia
Information provided by:	Barwon Health
ClinicalTrials.gov Identifier:	NCT00430547

Purpose

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.

Condition	Intervention
Graves' Ophthalmopathy	Drug: Carbimazole, radio-active iodine (I131)

Genetics Home Reference related topics: Lenz microphthalmia syndrome oculofaciocardiodental syndrome Peters plus syndrome

Drug Information available for: Iodine Cadexomer iodine Sodium iodide I 131 Immunoglobulins Globulin, Immune Thyroid Carbimazole

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Thyroid-Associated Ophthalmopathy Subtypes and Orbital Antibodies

Further study details as provided by Barwon Health:

Primary Outcome Measures:

Onset or progression of ophthalmopathy following radio-active iodine therapy

Estimated Enrollment:	60
Study Start Date:	August 2003
Estimated Study Completion Date:	January 2006

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00430547

Locations

Australia, Victoria
Barwon Health - The Geelong Hospital
Geelong, Victoria, Australia, 3220

Sponsors and Collaborators

Barwon Health

University of Melbourne

National Health and Medical Research Council, Australia

Investigators

Principal Investigator:

Jack R Wall, BMBS, FRACP, PhD

The University of Sydney

More Information

Study ID Numbers:	03/53
Study First Received:	February 1, 2007
Last Updated:	February 1, 2007
ClinicalTrials.gov Identifier:	NCT00430547
Health Authority:	Australia: National Health and Medical Research Council

Study placed in the following topic categories:

Goiter
Autoimmune Diseases
Graves Ophthalmopathy
Eye Diseases
Graves Disease
Endocrine System Diseases
Graves' disease
Antibodies

Eye Diseases, Hereditary
Iodine
Carbimazole
Orbital Diseases
Endocrinopathy
Thyroid Diseases
Hyperthyroidism
Immunoglobulins

Additional relevant MeSH terms:

Antithyroid Agents
Immune System Diseases
Hormone Antagonists
Physiological Effects of Drugs

Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Exophthalmos

ClinicalTrials.gov processed this record on January 14, 2009