drugset / Trial / NCT00407082
Safety and Efficacy of Fluocinolone Acetonide Intravitreal Implants
RandomizedParallel-groupDouble-blindTreatment
Summary
This is a multi-center, randomized, double-masked, controlled study to evaluate the safety and efficacy of fluocinolone acetonide (FA) intravitreal implants for the management of subjects with non-infectious uveitis affecting the posterior segment of the eye. An additional objective is to compare the safety and efficacy of two doses of fluocinolone acetonide.
Timeline
- Start
- 2000-12
- Primary completion
- 2005-09
- Completion
- 2005-09
Publications
- Results Jaffe GJ, Martin D, Callanan D, Pearson PA, Levy B, Comstock T; Fluocinolone Acetonide Uveitis Study Group. Fluocinolone acetonide implant (Retisert) for noninfectious posterior uveitis: thirty-four-week results of a multicenter randomized clinical study. Ophthalmology. 2006 Jun;113(6):1020-7. doi: 10.1016/j.ophtha.2006.02.021. Epub 2006 May 9.
- Callanan DG, Jaffe GJ, Martin DF, Pearson PA, Comstock TL. Treatment of posterior uveitis with a fluocinolone acetonide implant: three-year clinical trial results. Arch Ophthalmol. 2008 Sep;126(9):1191-201. doi: 10.1001/archopht.126.9.1191.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | fluocinolone acetonide | Small molecule | 0.59 mg | Intravitreal |
| Subject | fluocinolone acetonide | Small molecule | 2.1 mg | Intravitreal |