CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 592 enrolled
Drug / intervention
DE-109 44 ug +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01358266
NCT01358266Phase 3Completed

A Phase III, Multinational, Multicenter, Randomized, Double-Masked, Study for the Treatment of Active, Non-Infectious Uveitis of the Posterior Segment of the Eye

Santen Inc.·interventional·Posted May 23, 2011·Updated Jul 16, 2019

In Brief

A Phase 3 clinical trial evaluating DE-109 44 ug, DE-109 440 ug, and 1 other intervention for Uveitis; Posterior, Disorder. Completed, enrolled 592 participants across 151 sites in 17 countries.

Detailed Summary

The purpose of this study is to evaluate the safety and efficacy of intravitreal injections of DE-109 ophthalmic solution.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesArgentina, Austria, Brazil, Chile, Colombia, France, Germany, India, Israel, Italy, Japan, Peru, Poland, Spain, Turkey (Türkiye), United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMay 23, 2011
Enrollment StartMay 1, 2011
Primary CompletionSep 1, 2016
Study CompletionDec 1, 2016
TodayJul 2, 2026
Enrollment to primary: 5.3 yearsPosted 15.1 years ago

Interventions

DE-109 44 ugdrug

Low dose

DE-109 440 ugdrug

Medium dose

DE-109 880 ugdrug

High dose