drugset / Trial / NCT07594912
Teprotumumab N01 Versus Methylprednisolone After Urgent Orbital Decompression for Dysthyroid Optic Neuropathy
RandomizedParallel-groupOpen-labelTreatment
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).
Timeline
- Start
- 2026-08
- Primary completion
- 2027-12
- Completion
- 2028-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Methylprednisolone | Other / unclassified | 0.5 g | Intravenous |
| Comparator | Methylprednisolone | Other / unclassified | 1 g | Intravenous |
| Subject | Teprotumumab | Monoclonal antibody | 20 mg/kg | Intravenous |