At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 60 enrolled
Drug / intervention
DE-109 440 μgdrug
Likely dose
DE-109 440 μgfrom 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.
A Phase IIIb, Multinational, Multicenter, Open-Label Extension Study Assessing the Long-Term Safety of PRN Intravitreal Injections of DE-109 in Subjects With Non-Infectious Uveitis of the Posterior Segment of the Eye Who Have Participated in the SAKURA Development Program
In Brief
A Phase 3 clinical trial evaluating DE-109 440 μg for Non-Infectious Uveitis of the Posterior Segment of the Eye. Completed, enrolled 60 participants across 25 sites in 6 countries.
Detailed Summary
The objective of this extension study is to evaluate the long-term safety of treatment with DE-109 (440 μg) in subjects with non-infectious uveitis of the posterior segment of the eye who have participated in the SAKURA development program.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustria, France, India, Italy, Turkey (Türkiye), United States
Collaborators--
Timeline
Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedSep 2014
Enrollment StartSep 2014
Primary CompletionNov 2017
Study CompletionNov 2017
TodayJul 2026
First PostedSep 29, 2014
Enrollment StartSep 29, 2014
Primary CompletionNov 1, 2017
Study CompletionNov 27, 2017
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 11.8 years ago
Interventions
DE-109 440 μgdrug
Medium Dose