drugset / Trial / NCT00344968
Fluocinolone Acetonide Implant Compared to Sham Injection in Patients With Diabetic Macular Edema
RandomizedParallel-groupTriple-blindTreatment
Summary
This study will evaluate the safety and efficacy of an intravitreal insert of fluocinolone acetonide for the treatment of diabetic macular edema.
Timeline
- Start
- 2007-09
- Primary completion
- 2009-12
- Completion
- 2010-12
Publications
- Rittiphairoj T, Mir TA, Li T, Virgili G. Intravitreal steroids for macular edema in diabetes. Cochrane Database Syst Rev. 2020 Nov 17;11(11):CD005656. doi: 10.1002/14651858.CD005656.pub3.
- Holden SE, Kapik B, Beiderbeck AB, Currie CJ. Comparison of data characterizing the clinical effectiveness of the fluocinolone intravitreal implant (ILUVIEN) in patients with diabetic macular edema from the real world, non-interventional ICE-UK study and the FAME randomized controlled trials. Curr Med Res Opin. 2019 Jul;35(7):1165-1176. doi: 10.1080/03007995.2018.1560779. Epub 2019 Jan 17.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | fluocinolone acetonide | Small molecule | 0.2 mg | Intravitreal |
| Subject | fluocinolone acetonide | Small molecule | 0.5 mg | Intravitreal |