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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05486468 | The Use of Two YUTIQ Versus Sham for Treatment of Chronic Non Infectious Intraocular Inflammation Affecting the Posterior Segment | PHASE3 | RECRUITING | 30 | — | — | Oct 5, 2022 | Dec 1, 2026 | Aug 11, 2025 | 1 | United States |
The primary endpoint of recurrence rate of uveitis will be assessed at the 6-month visit. The clinical definition of intraocular inflammation recurrence is (1) a 2-step or more increase in number of cells in the anterior chamber per high-powered field (x1.6 using a 1-mm beam), (2) a 2-step or more increase in vitreous haze, or (3) a deterioration in BCVA of 15 letters or more. In each case, the etiology of the change must be only due to noninfectious uveitis.
| Arm | Type | Description |
|---|---|---|
| Treatment Arm | EXPERIMENTAL | This group will receive two YUTIQ implants at day 1. |
| Control Arm | SHAM_COMPARATOR | This group will receive two sham injections at day 1. |
| Name | Type | Description |
|---|---|---|
| Yutiq 0.18 MG Drug Implant | DRUG | YUTIQ ® (fluocinolone acetonide intravitreal implant) 0.18 mg, for intravitreal injection |
| Sham Injection | OTHER | Sham injection |
Inclusion Criteria: General Inclusion Criteria: 1. Male or non-pregnant female in good general health at least 18 years of age, understands the language of the informed consent, and is willing and able to provide written informed consent and sign/date a health information release (HIPAA form) befo...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Roivant Sciences Ltd. | ROIV | 1 | PHASE3 | Brepocitinib |
| Eli Lilly and Company | LLY | 1 | PHASE3 | Baricitinib, Adalimumab |
| ANI Pharmaceuticals, Inc. | ANIP | 1 | PHASE3 | Yutiq Drug |
| Regeneron Pharmaceuticals, Inc. | REGN | 1 | PHASE1 | REGN7041 |
| TScan Therapeutics, Inc. | TCRX | 1 | — | Undisclosed |