Early Risk Stratification of Thyroid Eye Disease in Newly Diagnosed Graves' Disease

NCT07812194 · tracked via the Priya Life Science Denmark tracker

Sponsor

University of Copenhagen

Phase

Observational

Started

2026-09-01

Last updated

2026-09-10

Condition(s) studied

Graves' OrbitopathyThyroid Eye Disease, TEDGraves' Disease

Investigational drug(s) / intervention(s)

Study-related ophthalmological assessment and biospecimen collectionBlood biomarkers and standardized blood samples including thyroid function status

Study-related ophthalmological assessment and biospecimen collection: Participants are not assigned to any treatment or therapeutic intervention as part of the study. Study-related procedures include standardized ophthalmological assessments, patient-reported outcome measures, blood sampling, tear-fluid collection using Schirmer strips, and conjunctival ocular surface swab sampling for ocular microbiome profiling. Standard clinical care is not altered by study participation.

Blood biomarkers and standardized blood samples including thyroid function status: No experimental or therapeutic interventions are administered. Participants undergo routine blood sampling (including thyroid function, biochemistry, hematology, lipids, and liver function markers) solely to gather baseline predictors for the TED prediction model

Study summary

The aim of this observational study is to investigate why some people with newly diagnosed Graves' disease (GD) develop thyroid eye disease (TED), also known as Graves' orbitopathy, while others do not.

The main questions the study aims to answer are:

1. What proportion of participants develop TED within one year of being diagnosed with GD?
2. Which early clinical signs, ophthalmological findings, blood biomarkers, tear-fluid biomarkers, or ocular surface microbiome characteristics are associated with an increased risk of developing thyroid eye disease?

Participants with newly diagnosed GD will attend two study visits, one at baseline and one approximately one year later. At each visit, participants will:

* Answer questions about their symptoms and quality of life
* Undergo a standardized eye examination and have clinical photographs taken of their eyes
* Provide blood samples, tear-fluid samples, and a small swab sample from the ocular surface

The study will also include healthy volunteers and participants with moderate-to-severe TED. Participants in these comparison groups will attend one study visit. Researchers will compare findings across the groups to better understand the early clinical and biological changes associated with thyroid eye disease.

The long-term aim is to improve the early detection and follow-up of people with GD who may be at increased risk of developing TED.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Accepted

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

Primary outcome measure(s)

Incidence of Thyroid Eye Disease (TED) within 12 months — Baseline to 12 months
Proportion of participants with newly diagnosed Graves' Disease (GD) who develop TED of any grade during the 12-month follow-up period. TED status is determined by standardized clinical and ophthalmological assessments using the established European Group on Graves' Orbitopathy (EUGOGO) criteria. Reported as a percentage (%) of participants.

Trial sites (1)

Facility	City	Region	Status
Department of Medical Diseases, Endocrinology Unit, Herlev-Gentofte Hospital	Herlev	Denmark

More University of Copenhagen trials in Denmark

Cancer-associated Muscle Mass - Molecular Factors and Exercise Mechanisms Recruiting

Ayurvedic Diet in Myxedema Recruiting

Does Paracetamol Influence the Release of Gut Hormones, Glucose Absorption and Glycemia? Recruiting

GastroFlow: Investigation of the Gastrointestinal Blood Flow in Patients With Postprandial Hypotension Enrolling by invitation

The Effect of Fasting on Peak Fat Oxidation, Mitochondrial Coupling and Extracellular Matrix Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07812194 on ClinicalTrials.gov ↗ ← All trials in Denmark