drugset / Trial / NCT03958344
Intraorbital Injection Versus Oral Steroid in Anterior Idiopathic Orbital Inflammation
Phase 3
Unknown
120 enrolled
Iran University of Medical Sciences
Mashhad University of Medical Sciences · collabShahid Beheshti University of Medical Sciences · collabTehran University of Medical Sciences · collab
RandomizedParallel-groupDouble-blindTreatment
Summary
A multicenter randomised double-arm clinical trial, to compare safety and efficacy of oral versus intralesional injection of steroid in a group of patients suffering from idiopathic orbital inflammation is designed. Outcome measures include number of recurrences, duration of remission, and side effects.
Timeline
- Start
- 2022-01-01
- Primary completion
- 2024-06-01
- Completion
- 2025-06-01
Publications
- Background Swamy BN, McCluskey P, Nemet A, Crouch R, Martin P, Benger R, Ghabriel R, Wakefield D. Idiopathic orbital inflammatory syndrome: clinical features and treatment outcomes. Br J Ophthalmol. 2007 Dec;91(12):1667-70. doi: 10.1136/bjo.2007.124156. Epub 2007 Jul 9.
- Background Bijlsma WR, Paridaens D, Kalmann R. Treatment of severe idiopathic orbital inflammation with intravenous methylprednisolone. Br J Ophthalmol. 2011 Aug;95(8):1068-71. doi: 10.1136/bjo.2010.195552. Epub 2011 Feb 24.
- Results El Nasser A Mohammad A. Local steroid injection for management of different types of acute idiopathic orbital inflammation: an 8-year study. Ophthalmic Plast Reconstr Surg. 2013 Jul-Aug;29(4):286-9. doi: 10.1097/IOP.0b013e318293750c.
- Results Leibovitch I, Prabhakaran VC, Davis G, Selva D. Intraorbital injection of triamcinolone acetonide in patients with idiopathic orbital inflammation. Arch Ophthalmol. 2007 Dec;125(12):1647-51. doi: 10.1001/archopht.125.12.1647.
- Results Reggie S, Neimkin M, Holds J. Intralesional corticosteroid injections as treatment for non-infectious orbital inflammation. Orbit. 2018 Feb;37(1):41-47. doi: 10.1080/01676830.2017.1353110. Epub 2017 Sep 5.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Betamethasone | Other / unclassified | 6 mg | Other |
| Comparator | Prednisolone | Other / unclassified | 1 mg/kg | Oral |
| Subject | Triamcinolone | Other / unclassified | 40 mg | Other |