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Eye damage in Graves' disease: can early clues predict who is at risk?

NCT ID NCT07812194

Knowledge-focused Sponsor: University of Copenhagen Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 10, 2026 · Last updated Sep 11, 2026 · Updated 1 time

Summary

Researchers at the University of Copenhagen are studying why some people with newly diagnosed Graves' disease develop thyroid eye disease while others do not. The study follows about 430 participants for one year, collecting eye exams, blood and tear samples, and symptom questionnaires. By comparing people who develop eye problems with those who do not, the team aims to build a risk prediction model that could help doctors catch thyroid eye disease earlier.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If researchers identify early warning signs, doctors could monitor and treat people with Graves' disease before thyroid eye disease causes lasting damage.
What could go wrong
This observational study cannot prove cause and effect, and the findings may not apply to other populations. Participants receive no experimental treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 430 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Sep 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Newly diagnosed GD cohort: Potential participants will be identified through approved recruitment reports based on EPIC/Sundhedsplatformen and laboratory data. Reports will identify adults referred to endocrinology outpatient clinics in the Capital Region of Denmark with first-time TRAb \>1.5 IU/L and TSH \<0.01 mU/L, and no previous TRAb \>1.5 IU/L. Participants may also be recruited through public announcements. Moderate-to-severe TED group: Participants will be identified among patients followed at the Endocrinology Outpatient Clinic, Herlev Hospital, and approached during a scheduled visit. Healthy control group: Participants will be recruited through staff advertisements at Herlev and Gentofte Hospital and public announcements.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Newly Diagnosed Graves' Disease (GD) Cohort: * Age 18 years or older * Newly diagnosed GD * Positive TSH receptor antibodies, defined as TRAb \>1.5 IU/L * Biochemical hyperthyroidism, defined as TSH \<0.01 mIU/L * Residence in and/or clinical management within the Capital Region of Denmark, including Hvidovre Hospital, Rigshospitalet, Amager Hospital, Nordsjællands Hospital, Herlev Hospital, and Bispebjerg Hospital. * Ability to provide oral and written informed consent Healthy Control Group: * Age 18 years or older * No known history of GD * No previous positive TRAb measurement * No known thyroid dysfunction requiring antithyroid drug therapy or thyroid hormone replacement therapy * Ability to provide oral and written informed consent Moderate-to-Severe Thyroid Eye Disease (TED) Group: * Age 18 years or older * Diagnosis of moderate-to-severe TED * Followed or treated in a relevant specialized clinical setting * Ability to provide oral and written informed consent Exclusion Criteria: Newly Diagnosed GD Cohort: * Age below 18 years * Previous documented TRAb measurement \>1.5 IU/L prior to the current diagnostic episode * Inability to provide informed consent * Inability to complete the baseline assessment within the predefined study timeframe Healthy Control Group: * Age below 18 years * Known Graves' disease or previous positive TRAb measurement * Known thyroid dysfunction requiring antithyroid drug therapy or thyroid hormone replacement therapy * Inability to provide informed consent Moderate-to-Severe TED Group: * Age below 18 years * Inability to provide informed consent * Inability to complete the planned study assessment

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Conditions

The condition(s) this trial relates to.

endocrine exophthalmos Graves disease Graves Ophthalmopathy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Graves disease Graves' orbitopathy Thyroid eye disease, ted

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Department of Medical Diseases, Endocrinology Unit, Herlev-Gentofte Hospital

    Herlev, 2730, Denmark

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