NCT00430547

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2003

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

August 1, 2003

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2006

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 1, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 2, 2007

Completed
Last Updated

February 2, 2007

Status Verified

August 1, 2003

First QC Date

February 1, 2007

Last Update Submit

February 1, 2007

Conditions

Graves' Ophthalmopathy

Outcome Measures

Primary Outcomes (1)

  • Onset or progression of ophthalmopathy following radio-active iodine therapy

Interventions

Carbimazole, radio-active iodine (I131)DRUG

Eligibility Criteria

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

You may qualify if:

  • Graves' disease diagnosed in the last 3 months, regardless of the presence of ophthalmopathy

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Barwon Health - The Geelong Hospital

Geelong, Victoria, 3220, Australia

Location

MeSH Terms

Conditions

Graves Ophthalmopathy

Interventions

CarbimazoleIodine-131

Condition Hierarchy (Ancestors)

Eye Diseases, HereditaryEye DiseasesGraves DiseaseExophthalmosOrbital DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGoiterThyroid DiseasesEndocrine System DiseasesHyperthyroidismAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Jack R Wall, BMBS, FRACP, PhD

    University of Sydney

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

February 1, 2007

First Posted

February 2, 2007

Study Start

August 1, 2003

Study Completion

January 1, 2006

Last Updated

February 2, 2007

Record last verified: 2003-08

Locations

AU(1)