A Phase III, Multi-National, Multi-Center, Randomized, Masked, Controlled, Safety and Efficacy Study of a Fluocinolone Acetonide Intravitreal Insert in Subjects With Chronic Non-Infectious Uveitis Affecting the Posterior Segment of the Eye
Active, no longer recruiting
Phase of Trial: Phase III
Latest Information Update: 12 Feb 2018
At a glance
- Drugs Fluocinolone acetonide (Primary)
- Indications Intermediate uveitis; Panuveitis; Posterior uveitis
- Focus Adverse reactions; Registrational; Therapeutic Use
- Sponsors pSivida
- 08 Jan 2018 According to a pSivida media release, the company has submitted an NDA to the US FDA for Durasert three-year treatment for posterior segment uveitis based on this and another phase III trial (CT 248911).
- 11 Sep 2017 According to a pSivida media release, the company is expecting to submit an NDA to the US FDA by late December or early January 2018.
- 10 Jul 2017 According to an Alimera Sciences media release, company anticipates that data from this and other phase III study will support the approval of ILUVIEN for the treatment of posterior uveitis in Europe, the Middle East and Africa.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History