Graves DiseaseNCT07480720
Systemic Inflammation, Thyroid Autoimmunity and Neuroretinal Changes in Graves Disease
An observational study of Graves Disease and Graves Ophthalmopathy, run by Elazıg Fethi Sekin Sehir Hastanesi at 1 site in Turkey (Türkiye).
Trial summary
This retrospective observational study aims to evaluate the relationship between systemic inflammatory parameters, thyroid autoimmunity markers, and neuroretinal structures in patients with Graves disease. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Graves Disease, Graves Ophthalmopathy
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2026to 1 May 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population will consist of adult patients diagnosed with Graves' disease who are followed in the endocrinology and ophthalmology clinics of the participating institution. Patients who meet the inclusion criteria and have available optical coherence tomography (OCT) measurements and laboratory data will be included in the patient group. The control group will consist of age- and sex-matched healthy volunteers without a history of thyroid disease or ocular pathology, recruited from individuals undergoing routine ophthalmologic examination. All participants will be evaluated for neuroretinal structural parameters using OCT and systemic inflammatory markers obtained from laboratory tests.
Who may be able to join
- Age ≥ 18 years
- Diagnosis of Graves' disease (for the patient group)
- No known thyroid disease in healthy control participants
- Availability of optical coherence tomography (OCT) measurements and laboratory data
- Time interval between OCT examination and blood sampling ≤ 10 days
Who cannot join
- Presence of glaucoma, optic neuropathy, or retinal vascular diseases
- Macular diseases, uveitis, or severe refractive error (high myopia >6 diopters)
- Diabetic retinopathy
- History of previous intraocular surgery
- History of active infection, malignancy, or systemic inflammatory disease
- Poor-quality OCT measurements (segmentation errors or low signal strength)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Fethi Sekin City Hospital
Elâzığ, Elaziğ
SİNEM KESER, MD, +905070646384, kesersinem@hotmail.com
About this study
Official title: Relationship Between Systemic Inflammation, Thyroid Autoimmunity, and Neuroretinal Structures in Graves Disease
This retrospective observational study aims to evaluate the relationship between systemic inflammatory parameters, thyroid autoimmunity markers, and neuroretinal structures in patients with Graves disease. Medical records of patients diagnosed with Graves disease and healthy control subjects evaluated at Elazığ Fethi Sekin City Hospital between August 2018 and January 2026 will be reviewed. Optical coherence tomography (OCT) measurements, including macular thickness and peripapillary retinal nerve fiber layer (RNFL) thickness, will be analyzed. Laboratory parameters such as complete blood count-derived inflammatory indices, C-reactive protein, thyroid function tests, and thyroid autoantibodies will also be recorded. The study will compare neuroretinal parameters between healthy controls, Graves disease patients without ophthalmopathy, and Graves disease patients with ophthalmopathy, and will investigate potential associations between systemic inflammation, thyroid autoimmunity, and neuroretinal structural changes.
- Conditions
- Graves Disease, Graves Ophthalmopathy
- Keywords
- Graves disease, Thyroid autoimmunity, Systemic inflammation, Optical coherence tomography, Retinal nerve fiber layer, Graves ophthalmopathy
- Medical subject headings
- Graves Disease, Graves Ophthalmopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Controls | Age-matched healthy individuals without known thyroid disease or autoimmune disorders who underwent ophthalmologic examination and optical coherence tomography evaluation. | |
| Graves Disease Without Ophthalmopathy | Patients diagnosed with Graves disease who do not have clinical signs of Graves ophthalmopathy and who underwent optical coherence tomography evaluation. | |
| Graves Disease With Ophthalmopathy | Patients diagnosed with Graves disease who have clinical findings consistent with Graves ophthalmopathy and who underwent optical coherence tomography evaluation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peripapillary Retinal Nerve Fiber Layer Thickness
Evaluation and comparison of peripapillary retinal nerve fiber layer thickness values in different quadrants among study groups.
Measured: Retrospective evaluation of OCT measurements obtained between August 2018 and January 2026
Macular Thickness Measured by Optical Coherence Tomography
Comparison of macular thickness measurements among healthy controls, Graves disease patients without ophthalmopathy, and Graves disease patients with ophthalmopathy.
Measured: Retrospective evaluation of OCT measurements obtained between August 2018 and January 2026
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2026
- Study start1 Mar 2026
- Primary completion1 Apr 2026 (estimated)
- Study completion1 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Graves DiseaseStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Elazıg Fethi Sekin Sehir Hastanesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sinem Keser, Elazıg Fethi Sekin Sehir Hastanesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07480720
- Sponsor's protocol ID
- FSCH-2026-24-07
- Status last verified
- Mar 2026
- First submitted
- 14 Mar 2026
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Systemic Inflammation, Thyroid Autoimmunity, and Neuroretinal Structures in Graves Disease
- ClinicalTrials.gov ID
- NCT07480720
- Acronym / sponsor ID
- FSCH-2026-24-07
- Conditions
- Graves Disease, Graves Ophthalmopathy
- Keywords
- Graves disease, Thyroid autoimmunity, Systemic inflammation, Optical coherence tomography, Retinal nerve fiber layer, Graves ophthalmopathy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Elazıg Fethi Sekin Sehir HastanesiUniversity, hospital or other
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 18 Mar 2026 (actual)
- 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.
This retrospective observational study aims to evaluate the relationship between systemic inflammatory parameters, thyroid autoimmunity markers, and neuroretinal structures in patients with Graves disease. Medical records of patients diagnosed with Graves disease and healthy control subjects evaluated at Elazığ Fethi Sekin City Hospital between August 2018 and January 2026 will be reviewed. Optical coherence tomography (OCT) measurements, including macular thickness and peripapillary retinal nerve fiber layer (RNFL) thickness, will be analyzed. Laboratory parameters such as complete blood count-derived inflammatory indices, C-reactive protein, thyroid function tests, and thyroid autoantibodies will also be recorded. The study will compare neuroretinal parameters between healthy controls, Graves disease patients without ophthalmopathy, and Graves disease patients with ophthalmopathy, and will investigate potential associations between systemic inflammation, thyroid autoimmunity, and neuroretinal structural changes.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy Controls | – | –Age-matched healthy individuals without known thyroid disease or autoimmune disorders who underwent ophthalmologic examination and optical coherence tomography evaluation. |
| Graves Disease Without Ophthalmopathy | – | –Patients diagnosed with Graves disease who do not have clinical signs of Graves ophthalmopathy and who underwent optical coherence tomography evaluation. |
| Graves Disease With Ophthalmopathy | – | –Patients diagnosed with Graves disease who have clinical findings consistent with Graves ophthalmopathy and who underwent optical coherence tomography evaluation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of adult patients diagnosed with Graves' disease who are followed in the endocrinology and ophthalmology clinics of the participating institution. Patients who meet the inclusion criteria and have available optical coherence tomography (OCT) measurements and laboratory data will be included in the patient group. The control group will consist of age- and sex-matched healthy volunteers without a history of thyroid disease or ocular pathology, recruited from individuals undergoing routine ophthalmologic examination. All participants will be evaluated for neuroretinal structural parameters using OCT and systemic inflammatory markers obtained from laboratory tests.
Key inclusion criteria (5 listed)
- Age ≥ 18 years
- Diagnosis of Graves' disease (for the patient group)
- No known thyroid disease in healthy control participants
- Availability of optical coherence tomography (OCT) measurements and laboratory data
- Time interval between OCT examination and blood sampling ≤ 10 days
Key exclusion criteria (6 listed)
- Presence of glaucoma, optic neuropathy, or retinal vascular diseases
- Macular diseases, uveitis, or severe refractive error (high myopia >6 diopters)
- Diabetic retinopathy
- History of previous intraocular surgery
- History of active infection, malignancy, or systemic inflammatory disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Peripapillary Retinal Nerve Fiber Layer Thickness
Time frame: Retrospective evaluation of OCT measurements obtained between August 2018 and January 2026
Evaluation and comparison of peripapillary retinal nerve fiber layer thickness values in different quadrants among study groups.
Macular Thickness Measured by Optical Coherence Tomography
Time frame: Retrospective evaluation of OCT measurements obtained between August 2018 and January 2026
Comparison of macular thickness measurements among healthy controls, Graves disease patients without ophthalmopathy, and Graves disease patients with ophthalmopathy.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
Related trials for Graves Disease
RecruitingPhase 1
Evaluation of ETHY-001 for Safety, Tolerability, and Clinical Activity in Thyroid Eye Disease
Thyroid Eye Disease (TED), Graves' Disease
Active, not recruitingPhase 2
Impact of Vitamin D Therapy on Thyroid Function and Antibody Levels in Pediatric Graves' Disease
Graves Disease, Graves' Disease
RecruitingPhase 2
A Study to Learn About The Effects of Felzartamab on Thyroid Function and Its Safety in Adults With Graves' Disease Ages 18 to 75 Years Old
Graves' Disease
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)
RecruitingPhase 3
Study to Assess Linsitinib in Participants With Moderate to Severe Active Thyroid Eye Disease (TED)
Thyroid Eye Disease, TED, Graves Orbitopathy
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Graves Disease and Graves Ophthalmopathy, run by Elazıg Fethi Sekin Sehir Hastanesi at 1 site in Turkey (Türkiye).
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 5 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 18 Mar 2026. 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 Turkey (Türkiye). 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact SİNEM KESER, MD (+905070646384, kesersinem@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peripapillary Retinal Nerve Fiber Layer Thickness (time frame: Retrospective evaluation of OCT measurements obtained between August 2018 and January 2026). The study lists 2 primary outcomes in all. 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 18 Mar 2026.