Trial · NCT07594912
Teprotumumab N01 Versus Methylprednisolone After Urgent Orbital Decompression for Dysthyroid Optic Neuropathy
NCT07594912, Phase 2, Not yet recruiting, Sun Yat-sen University
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Teprotumumab N01 Versus Methylprednisolone After Urgent Orbital Decompression for Dysthyroid Optic Neuropathy. Trials, record NCT07594912. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07594912
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Teprotumumab N01 Versus Methylprednisolone After Urgent Orbital Decompression for Dysthyroid Optic Neuropathy
- NCT number
- NCT07594912
- Status
- Not yet recruiting
- Phases
- Phase 2
- Enrollment
- 60 participants, estimated
- Lead sponsor
- Sun Yat-sen University
- Conditions
- Thyroid Eye Disease, TED, Graves Ophthalmopathy, Optic Neuropathy
- Interventions
- Teprotumumab N01, Intravenous Methylprednisolone (IVMP)
- First posted
- 2026-05-19
- Last updated
- 2026-05-19
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Best-Corrected Visual Acuity (BCVA) From Baseline to Week 24 | 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. |
| Secondary | Change in BCVA From Baseline to Week 12 | 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. |
| Secondary | Change in Visual Field Mean Deviation (VF-MD) Measured by Humphrey Field Analyzer | Baseline to Weeks 12 and 24 | 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. |
| Secondary | Clinical Activity Score (CAS) | Baseline to Weeks 12 and 24 | 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. |
| Secondary | Proptosis Measured by Hertel Exophthalmometry | Baseline to Weeks 12 and 24 | Proptosis will be measured in millimeters using a Hertel exophthalmometer. Higher values indicate greater proptosis. A negative change from baseline indicates improvement. |
| Secondary | Change in Gorman Diplopia Score | Baseline to Weeks 12 and 24 | 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. |
| Secondary | Color Vision Measured by Farnsworth Panel D-15 and Farnsworth-Munsell 100 Hue Tests | Baseline to Weeks 12 and 24 | 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. |
| Secondary | Graves' Orbitopathy Quality of Life Questionnaire Score（GO-QOL） | Baseline to Weeks 12 and 24 | 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. |
| Secondary | Incidence of Adverse Events and Serious Adverse Events | Baseline to Weeks 12 and 24 | 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. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07594912
GET https://conductscience.org/api/trials/v1/NCT07594912/registered