Last reviewed · How we verify
The Use of Two YUTIQ Versus Sham for Treatment of Chronic Non Infectious Intraocular Inflammation Affecting the Posterior Segment (TYNI Trial)
The Use of Two YUTIQ versus Sham for Treatment of Chronic Non Infectious Intraocular Inflammation Affecting the Posterior Segment (TYNI Trial)
Details
| Lead sponsor | Texas Retina Associates |
|---|---|
| Phase | Phase 3 |
| Status | RECRUITING |
| Enrolment | 30 |
| Start date | 2022-10-05 |
| Completion | 2026-12 |
Conditions
- Uveitis
- Uveitis, Posterior
- Uveitis, Anterior
- Uveitis, Intermediate
Interventions
- Yutiq 0.18 MG Drug Implant
- Sham Injection
Primary outcomes
- Recurrence rate of uveitis will be assessed at the 6-month visit — 6 months
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.
Countries
United States