drugset / Trial / NCT01781936

Pilot Study of a Fluocinolone Acetonide Intravitreal Insert (FA-i) to Treat Intermediate-, Posterior-, or Panuveitis

NCT01781936

Phase 1 Completed 17 enrolled Glenn Jaffe
NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to determine the tolerability, safety, and benefits of an investigational drug,Fluocinolone Acetonide Intravitreal Insert (FA-i), in people who have posterior uveitis. The study drug, Fluocinolone Acetonide, is currently used in a surgical implant, Retisert, which is approved by the U.S. Food and Drug Administration (FDA) to treat non-infectious posterior uveitis . The study drug is able to be inserted in an ophthalmology (eye) clinic; whereas Retisert must be surgically implanted in the Operating Room. Initially, this was a 2-dose randomized pilot study. However, the study was modified to include only the 0.2 ug/day implant.

Timeline

Start
2012-06
Primary completion
2018-06-13
Completion
2018-06-13

Drugs

EvaluationDrugModalityDoseRoute
Subject fluocinolone acetonide Small molecule 0.2 ug Intravitreal

Indications