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
Qualifiers
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
Treatments tested in this trial
- Teprotumumab N01
- Intravenous Methylprednisolone (IVMP)
Treatment groups
60 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov