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)
• 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.
• Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
⁃ Ocular Inclusion Criteria (Study Eye):
• Diagnosed with chronic unilateral or bilateral noninfectious posterior segment inflammation (with or without anterior uveitis) that demonstrated a clinical response to ≥1 previous corticosteroid treatment of any localized type (eg, topical steroid 2 to 4 times per day or intra- or peri-ocular injection) or systemic corticosteroid/immunosuppressant treatment with recurrence following treatment indicating chronicity according to the Investigator's judgment.
• Presence of active posterior segment inflammation as determined by the Investigator.
• Vitreous haze grade ≥ 2 based on the standardization of uveitis nomenclature (SUN) criteria.
• Less than 10 anterior chamber cells/high power field determined by slit lamp examination.
• Not planning to undergo elective ocular surgery during the study.