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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02748512 | Utilization and Safety of the Mk II Inserter and the Safety of the FAI Insert in Non-Infectious Uveitis | PHASE3 | COMPLETED | 26 | — | — | Feb 23, 2016 | Aug 17, 2017 | May 1, 2020 | 6 | United States |
The primary utilization endpoint was defined as the proportion of intravitreal insertion procedures that were assessed by the investigator as satisfactory. A satisfactory procedure was defined as one receiving a score from the Investigator as either Very Easy, Easy, or Routine.
| Arm | Type | Description |
|---|---|---|
| FAI Insert administered using the Mk II inserter | EXPERIMENTAL | The test article is the Fluocinolone Acetonide Intravitreal (FAI) insert, which contains 0.18 mg FA and delivers FA into the vitreous humor for 36 months, at a nominal rate of approximately 0.2 μg FA/day. The FAI insert will be administered to the study eye as an intravitreal injection through the pars plana. |
| FAI Insert administered using the Mk I inserter | ACTIVE_COMPARATOR | The test article is the Fluocinolone Acetonide Intravitreal (FAI) insert, which contains 0.18 mg FA and delivers FA into the vitreous humor for 36 months, at a nominal rate of approximately 0.2 μg FA/day. The FAI insert will be administered to the study eye as an intravitreal injection through the pars plana. |
| Name | Type | Description |
|---|---|---|
| FAI Insert administered using the Mk II inserter | DRUG | - |
| FAI Insert administered using the Mk I inserter | DRUG | - |
Inclusion Criteria: 1. Male or non-pregnant female at least 18 years of age at time of consent 2. At least one eye has a history of non-infectious uveitis affecting the posterior segment 3. Subject has ability to understand and sign the Informed Consent Form 4. Subject is willing and able to comply...