Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02746991 | Safety and Efficacy Study of a FAI Insert in Subjects With Chronic Non-infectious Posterior Uveitis | PHASE3 | COMPLETED | 153 | — | — | Jun 2, 2015 | Oct 4, 2019 | Jul 21, 2020 | 15 | India |
Proportion of Subjects with Recurrence of Uveitis in the Study Eye within 6 Months Including Reason for Imputed Recurrence (ITT Population)
| Arm | Type | Description |
|---|---|---|
| Sham Injection | SHAM_COMPARATOR | Sham Injection |
| FAI Insert | EXPERIMENTAL | FAI Insert (0.18 mg fluocinolone acetonide) |
| Name | Type | Description |
|---|---|---|
| Sham Injection | DRUG | Placebo |
| FAI Insert | DRUG | Fluocinolone Acetonide |
Inclusion Criteria: * Male or non pregnant female at least 18 years of age at time of consent * One or both eyes having a history of recurrent non-infectious uveitis affecting the posterior segment of the eye with or without anterior uveitis \> 1 year duration * At the time of enrollment (Day 1), s...