Actively Recruiting
The Use of Two YUTIQ Versus Sham for Treatment of Chronic Non Infectious Intraocular Inflammation Affecting the Posterior Segment (TYNI Trial)
Led by Texas Retina Associates · Updated on 2025-08-11
30
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
Sponsors
T
Texas Retina Associates
Lead Sponsor
E
Eye Point Pharmaceuticals
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the use of two YUTIQ implants compared to sham injections for managing chronic non-infectious intraocular inflammation affecting the back part of the eye, known as posterior uveitis. This condition can cause repeated inflammation episodes that may lead to permanent vision loss if not properly controlled. Previous studies showed that one YUTIQ implant helped reduce inflammation and vision loss, so this study aims to see if two implants provide even better control and fewer flare-ups. Participants will be randomly assigned to receive either two YUTIQ implants or two sham injections on the first day of the study. Both treatments are injected into the eye. The study team will compare how well the two YUTIQ implants control inflammation versus the sham injections over time. The main focus is on the rate of uveitis recurrence by 6 months, with further monitoring up to 12 months. During the study, participants will attend scheduled visits for eye exams, including checks for inflammation levels, visual acuity, and eye pressure. Researchers will monitor for any side effects and the time until inflammation returns. Participants must be able to follow the study visits and treatment plans over a year. The study includes careful assessments to understand the safety and effects of using two YUTIQ implants for this eye condition.
CONDITIONS
Brief Title
The Use of Two YUTIQ Versus Sham for Treatment of Chronic Non Infectious Intraocular Inflammation Affecting the Posterior Segment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or non-pregnant female in good general health at least 18 years old who understands and agrees to the study procedures
- Willingness and ability to follow scheduled visits, treatment plans, lab tests, and study procedures
- Diagnosed with chronic noninfectious inflammation in one or both eyes affecting the back of the eye, showing clinical response to at least one prior corticosteroid treatment
- Active inflammation in the back of the eye confirmed by the investigator
- Vitreous haze grade of 2 or greater based on standard criteria
- Less than 10 anterior chamber cells per high power field by slit lamp
- Not planning elective eye surgery during the study
You will not qualify if you...
- Known allergy to any component of YUTIQ
- Pregnant or breastfeeding females
- Any acute or chronic medical or psychiatric condition that may increase risk or prevent participation
- History of anterior uveitis only without posterior segment involvement
- Presence of vitreous hemorrhage
- Uveitis caused by infection
- Intraocular inflammation due to other causes, such as lymphoma
- Current infections of the eye including cornea, conjunctiva, mycobacterial, or fungal infections
- Presence of anterior chamber intraocular lens or ruptured posterior lens capsule
- Diagnosed glaucoma or ocular hypertension unless stable with up to 2 pressure-lowering medications or previous surgery
- Eye pressure over 21 mmHg or use of more than 2 pressure-lowering medications at screening
- Eye surgery within 12 weeks before study start
- Inability to attend scheduled follow-up visits during the 12 months
- Significant media opacity blocking evaluation of retina and vitreous in the study eye
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single day treatment with 12 months follow-up
Participants receive either two YUTIQ implants or two sham injections administered on day 1 to manage chronic non-infectious intraocular inflammation.
1 baseline visit (treatment) and regular follow-up visits over 12 months
Duration - Up to 12 months
Participants are monitored for recurrence of uveitis and safety over 12 months after treatment.
Visits at 6 months and 12 months with additional visits as scheduled
Trial Site Locations
Total: 1 location
1
Texas Retina Associates
Plano, Texas, United States, 75075
Actively Recruiting
Research Team
T
Tara Keesling, COA
J
Jodi Creighton
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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