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.
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.
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).
Parallel
Yutiq 0.18 MG Drug Implant
DrugYUTIQ ® (fluocinolone acetonide intravitreal implant) 0.18 mg, for intravitreal injection
Sham Injection
Other interventionSham injection
Recurrence rate of uveitis will be assessed at the 6-month visit
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.
Recurrence rate of uveitis at the 12-month visit
The secondary endpoints include determining the recurrence rate of uveitis at the 12-month visit, time to first uveitis recurrence, change in BCVA from baseline by ETDRS letters read at the 12-month visit, total number of necessary adjunctive treatments necessary, mean changes in CST as measured by SD-OCT, and mean changes from baseline in BCVA by ETDRS letters read. A final secondary endpoint will be to evaluate the changes in vascular leakage on FA, which will qualitatively be determined by the investigator.
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Texas Retina Associates
Lead sponsor
Eye Point Pharmaceuticals
Collaborator
ANI Pharmaceuticals
Collaborator
