About this trial
The Use of Two YUTIQ versus Sham for Treatment of Chronic Non Infectious Intraocular Inflammation Affecting the Posterior Segment (TYNI Trial)
Eligibility criteria
Qualifiers
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.
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.
Disqualifiers
Subjects with known hypersensitivity to any components of YUTIQ.
Female subjects who are pregnant or breastfeeding.
Has any acute or chronic medical disease or psychiatric condition that, in the opinion of the Investigator, would preclude participation in the study or put the subject at risk due to study treatment or procedures.
History of anterior uveitis only (without associated uveitis that affected the posterior segment).
Trial design
Treatments tested in this trial
- Yutiq 0.18 MG Drug Implant
- Sham Injection
Treatment groups
Sponsors and collaborators
Texas Retina Associates
Lead sponsor
Eye Point Pharmaceuticals
Collaborator
ANI Pharmaceuticals
Collaborator