Graves Ophthalmopathy

13

Review clinical trials related to Graves Ophthalmopathy. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Not yet recruiting

Prospective Observational Study of Smartphone-Based AI Self-Monitoring During Non-Surgical Treatment for Thyroid Eye Disease (THYROSCOPE)

This prospective observational study evaluates the feasibility and clinical utility of a smartphone-based artificial intelligence (AI) self-monitoring system in adults with thyroid eye disease (TED) undergoing non-surgical treatment. Eligible participants will use their own smartphones and the study application (Glandy) to perform at least weekly home monitoring consisting of a symptom questionnaire (diplopia, pain on visual analog scale) and a standardized frontal facial photograph. AI-derived outputs (Glandy CAS, Glandy EXO, Glandy LID) obtained at routine clinic visits will be compared with standard clinician assessments (CAS total score, Hertel exophthalmometry, MRD1/MRD2). AI outputs will not be used for real-time clinical decision-making during the study.

Participants needed: 200
Trial details
Age: 22+Biological sex: AllType: ObservationalSponsor: THYROSCOPE INC.Updated: Jun 3, 2026Locations: 1
Eligibility criteria

Adults aged 19 years or older with a clinical diagnosis of thyroid eye disease (... [+6]

Severe eyelid deformities, facial deformities, or other facial/periocular condit... [+5]

Status: Not yet recruiting

Teprotumumab N01 Versus Methylprednisolone After Urgent Orbital Decompression for Dysthyroid Optic Neuropathy

This study aims to evaluate the efficacy and safety of sequential Teprotumumab N01 compared with intravenous methylprednisolone (IVMP) after urgent orbital decompression in patients with dysthyroid optic neuropathy (DON).

Participants needed: 60
Trial details
Phase: Phase 2Age: 18-65Biological sex: AllType: InterventionalSponsor: Sun Yat-sen UniversityUpdated: May 19, 2026Locations: 1
Eligibility criteria

Able and willing to provide written informed consent. [+11]

Orbital decompression surgery within 6 months before screening. [+18]

Status: Recruiting

Tofacitinib for Glucocorticoid-Resistant Moderate-to-Severe Thyroid Eye Disease

Thyroid Eye Disease (TED), also known as Graves' orbitopathy, is an autoimmune condition that causes inflammation and tissue expansion behind the eyes, leading to bulging eyes (proptosis), double vision, and pain. Currently, intravenous glucocorticoids (steroids) are the standard first-line treatment. However, approximately 20-30% of patients do not respond to steroids, or cannot tolerate their side effects. This study aims to evaluate the safety and efficacy of Tofacitinib, an oral medication known as a Janus kinase (JAK) inhibitor, as a rescue therapy for these difficult-to-treat cases. Tofacitinib works by blocking specific signaling pathways (JAK-STAT) that drive inflammation and fibrosis in the eye socket. In this study, patients with moderate-to-severe active TED who are resistant to or intolerant of steroids will receive Tofacitinib tablets (5 mg twice daily) for 24 weeks. The researchers will assess whether the treatment can effectively reduce eye bulging and improve clinical activity scores.

Participants needed: 8
Trial details
Phase: Phase 2Age: 18-75Biological sex: AllType: InterventionalSponsor: The First Affiliated Hospital of Xiamen UniversityUpdated: Apr 29, 2026Locations: 1
Eligibility criteria

Age and Gender: Male or female participants aged 18 to 75 years (inclusive). [+7]

1.Sight-Threatening Disease: Presence of Dysthyroid Optic Neuropathy (DON) or se...

Status: Recruiting

Statin and Vitamin D Treatment in Patients With Thyroid Eye Disease

The goal of this clinical trial is to learn whether statin therapy and vitamin D supplementation can modify disease activity in patients with active thyroid eye disease. The study will also evaluate the safety of these treatments. The main questions it aims to answer are: * Does statin therapy change disease activity, as measured by changes in the Clinical Activity Score (CAS) and proptosis? * Does vitamin D supplementation change disease activity in patients with active thyroid eye disease? * Does combined treatment with statin and vitamin D produce different effects compared with either treatment alone or standard care? * What adverse events occur during treatment? Researchers will compare four groups: standard care alone, statin therapy plus standard care, vitamin D supplementation plus standard care, and combined statin and vitamin D therapy plus standard care. Participants will: * Be randomly assigned to one of four treatment groups * Receive the assigned treatment for 24 weeks * Attend clinic visits for clinical assessments and blood tests at baseline and at 24 weeks * Be followed through medical record review for up to three years after completion of the intervention

Participants needed: 120
Trial details
Age: 20+Biological sex: AllType: InterventionalSponsor: Taipei Veterans General Hospital, TaiwanUpdated: Apr 30, 2026Locations: 1
Eligibility criteria

Adults aged 20 years or older [+2]

Prior orbital radiotherapy or orbital surgery for thyroid eye disease [+3]

Status: Recruiting

Systemic Inflammation, Thyroid Autoimmunity and Neuroretinal Changes 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.

Participants needed: 100
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Elazıg Fethi Sekin Sehir HastanesiUpdated: Mar 18, 2026Locations: 1
Eligibility criteria

Age ≥ 18 years

Presence of glaucoma, optic neuropathy, or retinal vascular diseases

Status: Recruiting

Exploring Immunological Markers Associated With Mental Fatigue in Graves' Disease

Mental fatigue occurs in many diseases and the reasons are mostly unknown. The investigators hypothesize that remaining mental fatigue after restored hyperthyroidism in Graves' disease is an autoimmune complication. The aim of this study is to explore immunological markers possibly associated with mental fatigue in Graves' disease, which the investigators plan to validate in another study (ImmunoGraves wp 2). Using a cross-sectional study design, mental fatigue is scored using a questionnaire to find 60 patients with and 60 without mental fatigue 15-60 months after diagnosis of Graves disease. The patients and 60 thyroid healthy controls without mental fatigue are assessed for thyroid hormones, quality of life, anxiety and depression, self-evaluated stress, coping strategies, eye symptoms and background variables. SciLifeLab in Stockholm, the national facility for autoimmune profiling, has pre-set large arrays including 42000 human proteins. Serum and cerebrospinal fluid will be separately pooled and analysed for a subgroup of patients with or without mental fatigue and for a subgroup of the control group. Proteins that preferably bind to antibodies in sera and/or cerebrospinal fluid from Graves' patients with mental fatigue in comparison to non-mental fatigue patients, will be screened against the Human Protein Atlas and the Allen brain map to identify those proteins that are expressed in the brain. Antibodies at higher concentration in the mental fatigue pools compared to the group without mental fatigue will be selected for further analyses on an individual level in the whole cohort together with antibodies targeting g-protein coupled receptors, thyroid autoantibodies, cytokines and biomarkers indicating organic and structural nerve damage.

Participants needed: 180
Trial details
Age: 18-72Biological sex: FemaleType: ObservationalSponsor: Vastra Gotaland RegionUpdated: Sep 29, 2025Locations: 1
Eligibility criteria

If patient: Graves' disease with positive TSH-receptor antibodies and thyroid ho... [+5]

Person unable to follow protocol [+6]

Status: Recruiting

Bimatoprost as a Treatment for Graves' Orbitopathy

Testing whether Bimatoprost, a topical eye drop used for glaucoma, can be used to induce periorbital fat atrophy in patients with Graves' disease

Participants needed: 3
Trial details
Phase: Early Phase 1Age: 18+Biological sex: AllType: InterventionalSponsor: Johns Hopkins UniversityUpdated: Jul 17, 2025Locations: 1
Eligibility criteria

Not listed

Status: Recruiting

Extension Study of Two Doses of Linsitinib in Subjects With Active, Moderate to Severe Thyroid Eye Disease (TED)

The overall study objective is to continue to assess the efficacy, safety, pharmacokinetics, and pharmacodynamics of linsitinib in subjects who were enrolled in the prior VGN-TED-301 through Week 24. These subjects include VGN-TED-301 Week 24 proptosis non-responders or subjects who relapse during the Follow-Up Period of VGN-TED-301.

Participants needed: 75
Trial details
Phase: Phase 2, Phase 3Age: 18+Biological sex: AllType: InterventionalSponsor: Sling Therapeutics, Inc.Updated: Feb 25, 2025Locations: 2
Eligibility criteria

Subject who completed the 24-week double-mask period of VGN-TED-301 and are prop... [+3]

The exclusion criteria of protocol VGN-TED-301 also apply to this extension stud...

Status: Recruiting

Hydroxychloroquine in Mild Graves' Orbitopathy

This study is aimed to investigate the effect of hydroxychloroquine in patients with mild Graves' orbitopathy (GO).

Participants needed: 108
Trial details
Phase: Phase 4Age: 18-75Biological sex: AllType: InterventionalSponsor: National Taiwan University HospitalUpdated: Feb 25, 2025Locations: 2
Eligibility criteria

Mild GO according European Group on Graves' orbitopathy (EUGOGO) guidelines diag... [+2]

Moderate-to-sever or sight-threatening GO according to EUGOGO guidelines diagnos... [+15]

Status: Recruiting

Treatment of Graves´ophthalmopathy with Simvastatin (GO-S)

In an investigator initiated multicenter trial (Malmö, Odense, Århus) the investigators aim at evaluating activity of Graves´ophthalmopathy (GO) and progress to severe GO in patients with mild to moderate Graves´ ophthalmopathy treated with simvastatin or no treatment.

Participants needed: 80
Trial details
Phase: Phase 3Age: 18-70Biological sex: AllType: InterventionalSponsor: Lund UniversityUpdated: Sep 25, 2024Locations: 1
Eligibility criteria

Age 18-70 years [+2]

Pregnancy or breast-feeding [+12]

Status: Recruiting

Modified Orbital Decompression in the Treatment of Moderate-to-severe Grave's Ophthalmopathy

To investigate the efficacy and safety of modified deep lateral wall decompression and/or medial wall decompression for Moderate-to-severe Grave's Ophthalmopathy.

Participants needed: 50
Trial details
Age: 18-80Biological sex: AllType: InterventionalSponsor: Sun Yat-sen UniversityUpdated: Sep 19, 2024Locations: 1
Eligibility criteria

EUGOGO/NOSPECS grade was moderate-to-severe thyroid associate ophthalmopathy; [+3]

any uncontrollable clinical problems (severe mental, neurological, cardiovascula... [+3]

Status: Not yet recruiting

A Randomized Clinical Trial of Intravenous Methylprednisolone With 2 Protocols in Patients With Graves Orbitopathy

Intravenous glucocorticoid (IVGC) is an accessible and effective therapy for Graves orbitopathy (GO); the 4.5-g weekly protocol is well studied, but many details of treatment protocols need to be clarified. The goal of this trial is to compare the efficacy and safety of weekly and daily protocol of IVGC in GO. Researchers will compare daily protocol to weekly protocol to see if daily protocol works to treat GO.

Participants needed: 150
Trial details
Phase: Phase 4Age: 18-65Biological sex: AllType: InterventionalSponsor: Third Affiliated Hospital, Sun Yat-Sen UniversityUpdated: Jul 19, 2024
Eligibility criteria

Age 18-65 years old; [+3]

Status: Recruiting

The Effect of Teprotumumab on Thyroid Eye Disease and Thyroid Dysfunction

This protocol studies the clinical outcome of patients with active thyroid disease with visually significant signs and symptoms of proptosis, pain, diplopiam lid/orbital edema, or lid/orbital erythema recommended for treatment with teprotumumab infusion (Tepezza®). Patients recommended for treatment will be evaluated by an oculoplastic surgeon (Dr. Eva Chou) and endocrinologist (Dr. Thanh Hoang).

Participants needed: 100
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Walter Reed National Military Medical CenterUpdated: Feb 23, 2024Locations: 1
Eligibility criteria

only DOD beneficiaries [+2]

Patients with evidence of compressive optic neuropathy necessitating urgent orbi... [+4]