Thyroid Eye Disease, TEDPhase 2NCT07594912
Teprotumumab N01 Versus Methylprednisolone After Urgent Orbital Decompression for Dysthyroid Optic Neuropathy
A Phase 2 study testing Teprotumumab N01 and Intravenous Methylprednisolone (IVMP) in people with Thyroid Eye Disease, TED and Graves Ophthalmopathy, run by Sun Yat-sen University at 1 site in China.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Thyroid Eye Disease, TED, Graves Ophthalmopathy, Optic Neuropathy
- What is being tested?
- Teprotumumab N01 and Intravenous Methylprednisolone (IVMP)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Aug 2026to Apr 2028
- Phase
- Phase 2
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able and willing to provide written informed consent.
- Age 18 to 65 years.
- Clinical diagnosis of thyroid eye disease (TED) with dysthyroid optic neuropathy (DON). Diagnosis of DON must meet both of the following criteria:
- Visual dysfunction not explained by other causes, such as decreased best-corrected visual acuity, visual field defect, abnormal color vision, or relative afferent pupillary defect.
- Imaging evidence of orbital apex crowding, optic nerve compression, or optic nerve stretching.
- The study eye meets the criteria for urgent orbital decompression, defined as either of the following:
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- Poor response after rescue intravenous methylprednisolone for the current dysthyroid optic neuropathy episode, with a cumulative methylprednisolone-equivalent dose of no more than 3.0 g, defined as no improvement or continued deterioration of visual function within 1 to 2 weeks.
- Contraindication to glucocorticoids or investigator judgment that direct urgent mechanical decompression is required.
- Thyroid function is normal or mildly abnormal before enrollment, with free triiodothyronine (FT3) and free thyroxine (FT4) within 50% above or below the normal reference range when possible.
- Alanine aminotransferase (ALT) no more than 1.5 times the upper limit of normal, aspartate aminotransferase (AST) no more than 3 times the upper limit of normal, and serum creatinine no more than 1.5 times the upper limit of normal.
- For participants with diabetes mellitus, hemoglobin A1c (HbA1c) less than 9.0% and stable antidiabetic treatment within 60 days before enrollment.
- For women of childbearing potential, a pregnancy test must be negative before enrollment.
- Participants of reproductive potential agree to use effective contraception during the study and for 90 days after the last dose of study treatment.
- Able and willing to comply with study treatment and follow-up procedures.
Who cannot join
- Orbital decompression surgery within 6 months before screening.
- Bilateral dysthyroid optic neuropathy requiring urgent bilateral orbital decompression at baseline.
- Cumulative preoperative methylprednisolone-equivalent dose greater than 3.0 g for the current dysthyroid optic neuropathy episode.
- Systemic glucocorticoid treatment for non-thyroid eye disease within 3 months before screening with cumulative methylprednisolone-equivalent dose of 1.0 g or greater.
- Tocilizumab or other systemic immunosuppressive treatment within 3 months before screening, or rituximab within 6 months before screening.
- Orbital radiotherapy within 3 months before screening.
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- Previous treatment with teprotumumab.
- Other ocular diseases that may significantly affect visual function assessment, including glaucomatous optic neuropathy, macular disease, severe cataract, or non-thyroid eye disease optic neuropathy.
- Irreversible optic nerve damage in the study eye with very low potential for visual recovery, as judged by the investigator.
- History of definite inner ear disease or clinically significant hearing impairment.
- Severe cardiovascular disease.
- Severe hepatic or renal disease.
- Active infection or clinically significant infectious disease, including active hepatitis, HIV infection, syphilis, or active tuberculosis.
- Active gastrointestinal ulcer.
- Clinically significant abnormal blood test results, including white blood cell count less than 4.0 × 10^9/L, platelet count less than 80 × 10^9/L, hemoglobin less than 110 g/L in males or less than 100 g/L in females.
- History of malignancy judged by the investigator to be unsuitable for enrollment.
- Pregnancy or breastfeeding.
- Known allergy to monoclonal antibodies, methylprednisolone, or any study drug excipient.
- Uncontrolled diabetes mellitus or any other condition that, in the investigator's judgment, makes the participant unsuitable for the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, 510000
About this study
Official title: A Single-Center, Prospective, Randomized, Open-Label, Parallel-Group Study Comparing Sequential Teprotumumab N01 With Intravenous Methylprednisolone After Urgent Orbital Decompression in Patients With 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).
Read the detailed description
This study is designed to evaluate the efficacy and safety of sequential systemic treatment after urgent orbital decompression in patients with dysthyroid optic neuropathy.
All eligible participants will undergo standardized urgent orbital decompression. After surgery, participants will be randomized in a 1:1 ratio to receive either sequential Teprotumumab N01 or intravenous methylprednisolone. The study will compare visual function recovery, orbital signs, disease activity, quality of life, rescue treatment, recurrence, and safety between the two treatment groups.
The primary outcome is the change from baseline in best-corrected visual acuity at Week 24. Secondary outcomes include changes in visual field mean deviation, Clinical Activity Score, proptosis, diplopia, color vision, Graves' Orbitopathy Quality of Life questionnaire score, rescue treatment, recurrence, and adverse events.
- Being tested
- Teprotumumab N01, Intravenous Methylprednisolone (IVMP)
- Keywords
- Dysthyroid optic neuropathy, Orbital decompression, Teprotumumab N01, Intravenous methylprednisolone pulse, Thyroid eye disease
- Medical subject headings
- Graves Ophthalmopathy, Optic Nerve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Teprotumumab N01Drug
Also called Teprotumumab, Insulin-like growth factor-1 receptor monoclonal antibody, IGF-1R inhibitor
Teprotumumab N01 will be administered intravenously after urgent orbital decompression. The first infusion will be 10 mg/kg, followed by 20 mg/kg every 3 weeks for 7 additional infusions.
Intravenous Methylprednisolone (IVMP)Drug
Also called Methylprednisolone, Methylprednisolone sodium succinate, Intravenous methylprednisolone pulse therapy, IVMP
IVMP will be administered after urgent orbital decompression at 0.5 to 1.0 g per day for 3 consecutive days, followed by oral prednisone tapering according to the participant's clinical status and investigator judgment.
| Study group | Role | What they receive |
|---|---|---|
| Postoperative Sequential Teprotumumab N01 | Experimental | Participants in this arm will undergo urgent orbital decompression and then receive postoperative sequential Teprotumumab N01. Receives: Drug: Teprotumumab N01 |
| Postoperative Sequential Intravenous Methylprednisolone | Active comparator | Participants in this arm will undergo urgent orbital decompression and then receive postoperative sequential intravenous methylprednisolone. Receives: Drug: Intravenous Methylprednisolone (IVMP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Best-Corrected Visual Acuity (BCVA) From Baseline to Week 24
BCVA will be assessed using a Snellen visual acuity chart and converted to logarithm of the minimum angle of resolution (logMAR) units for analysis. Lower logMAR values indicate better visual acuity. A negative change from baseline indicates improvement.
Measured: Baseline to Week 24
Secondary outcomes (8)
Change in BCVA From Baseline to Week 12
BCVA will be assessed using a Snellen visual acuity chart and converted to logarithm of the minimum angle of resolution (logMAR) units for analysis. Lower logMAR values indicate better visual acuity. A negative change from baseline indicates improvement.
Measured: Baseline to Week 12
Change in Visual Field Mean Deviation (VF-MD) Measured by Humphrey Field Analyzer
VF-MD will be measured in decibels using the Humphrey Field Analyzer. Higher or less negative VF-MD values indicate better visual field function. A positive change from baseline indicates improvement.
Measured: Baseline to Weeks 12 and 24
Clinical Activity Score (CAS)
CAS will be used to assess disease activity in thyroid eye disease (TED). The 7-item CAS (CAS-7) will be used at baseline and ranges from 0 to 7. The 10-item CAS (CAS-10) will be used during follow-up and ranges from 0 to 10. Higher scores indicate more active inflammation, greater recent disease progression, and worse disease activity.
Measured: Baseline to Weeks 12 and 24
Proptosis Measured by Hertel Exophthalmometry
Proptosis will be measured in millimeters using a Hertel exophthalmometer. Higher values indicate greater proptosis. A negative change from baseline indicates improvement.
Measured: Baseline to Weeks 12 and 24
Change in Gorman Diplopia Score
Diplopia will be graded using the Gorman diplopia score. Scores range from 0 to 3, where 0 indicates no diplopia, 1 indicates intermittent diplopia, 2 indicates inconstant diplopia, and 3 indicates constant diplopia. Higher scores indicate worse diplopia. A negative change from baseline indicates improvement.
Measured: Baseline to Weeks 12 and 24
Color Vision Measured by Farnsworth Panel D-15 and Farnsworth-Munsell 100 Hue Tests
Color vision will be assessed using the Farnsworth Panel D-15 test and the Farnsworth-Munsell 100 Hue test. The Farnsworth Panel D-15 test will be recorded as normal or abnormal color discrimination. The Farnsworth-Munsell 100 Hue test will be recorded using the total error score, with lower scores indicating better color discrimination. A decrease in total error score from baseline indicates improvement.
Measured: Baseline to Weeks 12 and 24
Graves' Orbitopathy Quality of Life Questionnaire Score（GO-QOL）
The GO-QOL is a 16-item disease-specific questionnaire designed to measure health-related quality of life in patients with Graves' ophthalmopathy. It comprises two subscales: visual functioning (8 items) and appearance (8 items). Scores for each subscale are transformed to a range of 0 (worst possible quality of life) to 100 (best possible quality of life). A higher score indicates better quality of life. A positive change from baseline indicates improvement.
Measured: Baseline to Weeks 12 and 24
Incidence of Adverse Events and Serious Adverse Events
Adverse events and serious adverse events will be recorded throughout the study period. The incidence, severity, seriousness, and relationship to study treatment will be summarized by treatment group.
Measured: Baseline to Weeks 12 and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2026
- Study startAug 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid Eye Disease, TEDStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Huasheng Yang, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07594912
- Sponsor's protocol ID
- yanghs20250429
- Status last verified
- May 2026
- First submitted
- 5 May 2026
- Last updated
- 19 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Prospective, Randomized, Open-Label, Parallel-Group Study Comparing Sequential Teprotumumab N01 With Intravenous Methylprednisolone After Urgent Orbital Decompression in Patients With Dysthyroid Optic Neuropathy
- ClinicalTrials.gov ID
- NCT07594912
- Acronym / sponsor ID
- yanghs20250429
- Keywords
- Dysthyroid optic neuropathy, Orbital decompression, Teprotumumab N01, Intravenous methylprednisolone pulse, Thyroid eye disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- Aug 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 19 May 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 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).
Detailed description
This study is designed to evaluate the efficacy and safety of sequential systemic treatment after urgent orbital decompression in patients with dysthyroid optic neuropathy.
All eligible participants will undergo standardized urgent orbital decompression. After surgery, participants will be randomized in a 1:1 ratio to receive either sequential Teprotumumab N01 or intravenous methylprednisolone. The study will compare visual function recovery, orbital signs, disease activity, quality of life, rescue treatment, recurrence, and safety between the two treatment groups.
The primary outcome is the change from baseline in best-corrected visual acuity at Week 24. Secondary outcomes include changes in visual field mean deviation, Clinical Activity Score, proptosis, diplopia, color vision, Graves' Orbitopathy Quality of Life questionnaire score, rescue treatment, recurrence, and adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Postoperative Sequential Teprotumumab N01 | Experimental | Drug: Teprotumumab N01Participants in this arm will undergo urgent orbital decompression and then receive postoperative sequential Teprotumumab N01. |
| Postoperative Sequential Intravenous Methylprednisolone | Active comparator | Drug: Intravenous Methylprednisolone (IVMP)Participants in this arm will undergo urgent orbital decompression and then receive postoperative sequential intravenous methylprednisolone. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Able and willing to provide written informed consent.
- Age 18 to 65 years.
- Clinical diagnosis of thyroid eye disease (TED) with dysthyroid optic neuropathy (DON). Diagnosis of DON must meet both of the following criteria:
- The study eye meets the criteria for urgent orbital decompression, defined as either of the following:
- Thyroid function is normal or mildly abnormal before enrollment, with free triiodothyronine (FT3) and free thyroxine (FT4) within 50% above or below the normal reference range when possible.
Key exclusion criteria (19 listed)
- Orbital decompression surgery within 6 months before screening.
- Bilateral dysthyroid optic neuropathy requiring urgent bilateral orbital decompression at baseline.
- Cumulative preoperative methylprednisolone-equivalent dose greater than 3.0 g for the current dysthyroid optic neuropathy episode.
- Systemic glucocorticoid treatment for non-thyroid eye disease within 3 months before screening with cumulative methylprednisolone-equivalent dose of 1.0 g or greater.
- Tocilizumab or other systemic immunosuppressive treatment within 3 months before screening, or rituximab within 6 months before screening.
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 |
|---|---|---|
| Teprotumumab N01Also: Teprotumumab, Insulin-like growth factor-1 receptor monoclonal antibody, IGF-1R inhibitorTeprotumumab N01 will be administered intravenously after urgent orbital decompression. The first infusion will be 10 mg/kg, followed by 20 mg/kg every 3 weeks for 7 additional infusions. | Drug | Postoperative Sequential Teprotumumab N01 |
| Intravenous Methylprednisolone (IVMP)Also: Methylprednisolone, Methylprednisolone sodium succinate, Intravenous methylprednisolone pulse therapy, IVMPIVMP will be administered after urgent orbital decompression at 0.5 to 1.0 g per day for 3 consecutive days, followed by oral prednisone tapering according to the participant's clinical status and investigator judgment. | Drug | Postoperative Sequential Intravenous Methylprednisolone |
Primary outcome
Change in Best-Corrected Visual Acuity (BCVA) From Baseline to Week 24
Time frame: Baseline to Week 24
BCVA will be assessed using a Snellen visual acuity chart and converted to logarithm of the minimum angle of resolution (logMAR) units for analysis. Lower logMAR values indicate better visual acuity. A negative change from baseline indicates improvement.
8 secondary outcomes
Change in BCVA From Baseline to Week 12
Time frame: Baseline to Week 12
Change in Visual Field Mean Deviation (VF-MD) Measured by Humphrey Field Analyzer
Time frame: Baseline to Weeks 12 and 24
Clinical Activity Score (CAS)
Time frame: Baseline to Weeks 12 and 24
Proptosis Measured by Hertel Exophthalmometry
Time frame: Baseline to Weeks 12 and 24
Change in Gorman Diplopia Score
Time frame: Baseline to Weeks 12 and 24
Color Vision Measured by Farnsworth Panel D-15 and Farnsworth-Munsell 100 Hue Tests
Time frame: Baseline to Weeks 12 and 24
Graves' Orbitopathy Quality of Life Questionnaire Score（GO-QOL）
Time frame: Baseline to Weeks 12 and 24
Incidence of Adverse Events and Serious Adverse Events
Time frame: Baseline to Weeks 12 and 24
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 19 May 2026.
- Individual participant dataSharing planned: No
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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?
A Phase 2 study testing Teprotumumab N01 and Intravenous Methylprednisolone (IVMP) in people with Thyroid Eye Disease, TED and Graves Ophthalmopathy, run by Sun Yat-sen University at 1 site in China.
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 14 inclusion and 19 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: opening soon, as of the sponsor's last update on 19 May 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 China. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Hui jing Ye, M.D, PhD (+8620-87331539, yehuijing@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Best-Corrected Visual Acuity (BCVA) From Baseline to Week 24 (time frame: Baseline to Week 24). 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 19 May 2026.