Teprotumumab N01 Versus Methylprednisolone After Urgent Orbital Decompression for Dysthyroid Optic Neuropathy
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorSun Yat-sen University
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Able and willing to provide written informed consent.
Age 18 to 65 years.
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Teprotumumab N01
DrugTeprotumumab 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)
DrugIVMP 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.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Postoperative Sequential Teprotumumab N01Experimental treatment 1 intervention
Group B: Postoperative Sequential Intravenous MethylprednisoloneActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline to Week 24Secondary outcomes
1
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.
Time frame
Baseline to Week 122
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.
Time frame
Baseline to Weeks 12 and 243
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.
Time frame
Baseline to Weeks 12 and 244
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.
Time frame
Baseline to Weeks 12 and 24Sponsors and contacts
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Source ClinicalTrials.gov
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