drugset / Trial / NCT04936854
Sirolimus vs Corticosteroids in Treatment of Thyroid Eye Disease
RandomizedParallel-groupSingle-blindTreatment
Summary
The purpose of this study is to determine whether Sirolimus is more effective and burdened with less side effects than conventional treatment with corticosteroids in patients with active thyroid eye disease.
Timeline
- Start
- 2023-01-01
- Primary completion
- 2028-01
- Completion
- 2028-12
Publications
- Background Roos JCP, Murthy R. Sirolimus (rapamycin) for the targeted treatment of the fibrotic sequelae of Graves' orbitopathy. Eye (Lond). 2019 Apr;33(4):679-682. doi: 10.1038/s41433-019-0340-3. Epub 2019 Feb 12.
- Background Chang S, Perry JD, Kosmorsky GS, Braun WE. Rapamycin for treatment of refractory dysthyroid compressive optic neuropathy. Ophthalmic Plast Reconstr Surg. 2007 May-Jun;23(3):225-6. doi: 10.1097/IOP.0b013e3180500d57.
- Background Roos JCP, Eglitis V, Murthy R. Inhibition of Fibrotic Contraction by Sirolimus (Rapamycin) in an Ex Vivo Model of Thyroid Eye Disease. Ophthalmic Plast Reconstr Surg. 2021 Jul-Aug 01;37(4):366-371. doi: 10.1097/IOP.0000000000001876.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Methylprednisolone | Other / unclassified | 250 mg | Intravenous |
| Comparator | Sirolimus | Small molecule | 0.5 mg | Oral |