At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 153 enrolled
Drug / intervention
Sham Injection +1 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.
A Multi-center, Controlled, Safety and Efficacy Study of a Fluocinolone Acetonide Intravitreal (FAI) Insert in Subjects With Chronic Non-infectious Uveitis Affecting the Posterior Segment of the Eye
In Brief
A Phase 3 clinical trial evaluating Sham Injection and FAI Insert for Posterior Uveitis and 2 related conditions. Completed, enrolled 153 participants across 15 sites.
Detailed Summary
Phase 3, multi-center, randomized, masked, controlled study to evaluate the safety and efficacy of an injectable fluocinolone acetonide intravitreal (FAI) insert for the management of subjects with chronic non-infectious uveitis affecting the posterior segment of the eye. Patients will be randomized to receive either a sham injection or the FAI insert and will be observed for three years following treatment.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPosterior Uveitis, Intermediate Uveitis, Panuveitis
CountriesIndia
Collaborators--
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
Enrollment StartJun 2015
First PostedApr 2016
Primary CompletionOct 2019
TodayJul 2026
First PostedApr 21, 2016
Enrollment StartJun 2, 2015
Primary CompletionOct 4, 2019
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 10.2 years ago
Interventions
Sham Injectiondrug
Placebo
FAI Insertdrug
Fluocinolone Acetonide