The Use of Two YUTIQ Versus Sham for Treatment of Chronic Non Infectious Intraocular Inflammation Affecting the Posterior Segment (TYNI Trial)
Texas Retina Associates
Summary
The Use of Two YUTIQ versus Sham for Treatment of Chronic Non Infectious Intraocular Inflammation Affecting the Posterior Segment (TYNI Trial)
Description
1.0 RATIONALE AND NEEDS ASSESSMENT Primary Eyepoint Drug(s): YUTIQ Study Rationale: The current data shows that in eyes from patients with chronic non-infectious posterior uveitis(NIPU), a single YUTIQ implant decreases the number of uveitis recurrences, led to less necessary adjunctive treatments, demonstrated less visual acuity loss, and had an acceptable side effect profile. Naturally, we asked whether two YUTIQ implants at the time of treatment would lead to an improved level of control of intraocular inflammation. We propose to evaluate the safety and efficacy of two YUTIQ implants vers…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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) before any study procedures are performed. 2. Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. Ocular Inclusion Criteria (Study Eye): 1. Diagnosed with chronic unilateral or bilateral noninfectious posterior segment inflammation (wi…
Interventions
- DrugYutiq 0.18 MG Drug Implant
YUTIQ ® (fluocinolone acetonide intravitreal implant) 0.18 mg, for intravitreal injection
- OtherSham Injection
Sham injection
Location
- Texas Retina AssociatesPlano, Texas