At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 26 enrolled
Drug / intervention
FAI Insert administered using the Mk II inserter +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 Controlled, Multi-Center Study of the Utilization and Safety of the MkII Inserter and the Safety of the FAI Insert in Subjects With Non-Infectious Uveitis Affecting the Posterior Segment of the Eye.
In Brief
A Phase 3 clinical trial evaluating FAI Insert administered using the Mk II inserter and FAI Insert administered using the Mk I inserter for Non-Infectious Uveitis. Completed, enrolled 26 participants across 6 sites.
Detailed Summary
This trial is a 12 month, Phase 3, multi-center, randomized, single-masked (subject), controlled study designed to evaluate the utilization and safety of the Mk II inserter and the safety of the FAI insert, in subjects with non-infectious uveitis affecting the posterior segment of the eye.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNon-Infectious Uveitis
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
Enrollment StartFeb 2016
First PostedApr 2016
Primary CompletionAug 2017
TodayJul 2026
First PostedApr 22, 2016
Enrollment StartFeb 23, 2016
Primary CompletionAug 17, 2017
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 10.2 years ago
Interventions
FAI Insert administered using the Mk II inserterdrug
FAI Insert administered using the Mk I inserterdrug