Graves' OphthalmopathyNCT00430547
Thyroid-Associated Ophthalmopathy Subtypes and Orbital Antibodies
A study testing Carbimazole, radio-active iodine (I131) in people with Graves' Ophthalmopathy, run by Barwon Health at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Graves' Ophthalmopathy
- What is being tested?
- Carbimazole, radio-active iodine (I131)
- How many people
- 60 participants
- Where
- 1 siteAustralia
- Study dates
- Aug 2003to Jan 2006
- 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
- Graves' disease diagnosed in the last 3 months, regardless of the presence of ophthalmopathy
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Australia1 site
Barwon Health - The Geelong Hospital
Geelong, Victoria, 3220
About this study
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.
- Conditions
- Graves' Ophthalmopathy
- Being tested
- Carbimazole, radio-active iodine (I131)
- Medical subject headings
- Graves Ophthalmopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carbimazole, radio-active iodine (I131)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Onset or progression of ophthalmopathy following radio-active iodine therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2007 (estimated)
- Study startAug 2003
- Study completionJan 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Graves' OphthalmopathyStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- Barwon Health
- Sponsor type
- Other government
- Collaborators
- University of Melbourne, National Health and Medical Research Council, Australia
- Investigators
- Jack R Wall, BMBS, FRACP, PhD, Principal investigator, University of Sydney
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00430547
- Sponsor's protocol ID
- 03/53
- Status last verified
- Aug 2003
- First submitted
- 1 Feb 2007
- Last updated
- 2 Feb 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thyroid-Associated Ophthalmopathy Subtypes and Orbital Antibodies
- ClinicalTrials.gov ID
- NCT00430547
- Acronym / sponsor ID
- 03/53
- Conditions
- Graves' Ophthalmopathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants
- Lead sponsor
- Barwon HealthOther government
- Collaborators
- University of Melbourne, National Health and Medical Research Council, Australia
- Study start
- Aug 2003
- Study completion
- Jan 2006
- First posted
- 2 Feb 2007 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Graves' disease diagnosed in the last 3 months, regardless of the presence of ophthalmopathy
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| Carbimazole, radio-active iodine (I131) | Drug | – |
Primary outcome
Onset or progression of ophthalmopathy following radio-active iodine therapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2007.
Related trials for Graves' Ophthalmopathy
Active, not recruitingPhase 4
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Early Risk Stratification of Thyroid Eye Disease in Newly Diagnosed Graves' Disease
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Evaluation of ETHY-001 for Safety, Tolerability, and Clinical Activity in Thyroid Eye Disease
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RecruitingPhase 3
Study to Assess Linsitinib in Participants With Moderate to Severe Active Thyroid Eye Disease (TED)
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Not yet recruitingPhase 2
Prophylactic Treatment of Graves Ophthalmopathy (GO) in Newly Diagnosed Graves' Disease (GD) With Atorvastatin (ATORGO)
Graves Disease, Graves Disease (Basedow's Disease)
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.
Jack R Wall, BMBS, FRACP, PhD principal investigator
University of Sydney
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Carbimazole, radio-active iodine (I131) in people with Graves' Ophthalmopathy, run by Barwon Health at 1 site in Australia.
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 1 inclusion and 5 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: finished, as of the sponsor's last update on 2 Feb 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Onset or progression of ophthalmopathy following radio-active iodine therapy. 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 2 Feb 2007; AzTrials last refreshed its copy on 6 Nov 2026.