Two YUTIQ implants versus sham injections for chronic noninfectious posterior uveitis

The Use of Two YUTIQ Versus Sham for Treatment of Chronic Non Infectious Intraocular Inflammation Affecting the Posterior Segment (TYNI Trial)

This test will see if giving two YUTIQ eye implants works better than two sham injections to control chronic noninfectious posterior uveitis in adults.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Texas Retina Associates (Academic / other)
• Locations: 1 site (Plano, Texas)
• Trial ID: NCT05486468 on ClinicalTrials.gov

What this trial studies

This Phase 3 interventional trial compares two YUTIQ intraocular implants to two sham injections in adults with chronic noninfectious posterior-segment uveitis. Eligible participants have active posterior inflammation with prior clinical response to corticosteroids and will receive either two drug implants or two sham procedures. Investigators will track inflammation recurrences, need for adjunctive treatments, best-corrected visual acuity, and safety outcomes over the follow-up period. The goal is to determine whether two implants provide improved control of inflammation and acceptable side effect profiles compared with sham.

Who should consider this trial

Good fit: Adults (≥18 years) with chronic noninfectious posterior-segment uveitis who have active posterior inflammation and have shown a clinical response to prior corticosteroid treatment are the intended participants.

Not a fit: Patients with infectious uveitis, those for whom intraocular steroid implants are contraindicated (for example uncontrolled glaucoma), pregnant individuals, children, or people unable to attend the Plano, Texas site are unlikely to benefit from participating.

Why it matters

Potential benefit: If successful, two YUTIQ implants could reduce uveitis flare-ups, decrease the need for additional treatments, and help preserve vision.

How similar studies have performed: Previous trials showed that a single YUTIQ implant reduced recurrences and vision loss compared with sham, and this trial tests whether two implants provide additional benefit.

Eligibility criteria

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 (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.
2. Presence of active posterior segment inflammation as determined by the Investigator.
3. Vitreous haze grade ≥ 2 based on the standardization of uveitis nomenclature (SUN) criteria.
4. Less than 10 anterior chamber cells/high power field determined by slit lamp examination.
5. Not planning to undergo elective ocular surgery during the study.

Exclusion Criteria:

General Exclusion Criteria:

1. Subjects with known hypersensitivity to any components of YUTIQ.
2. Female subjects who are pregnant or breastfeeding.
3. 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.

Ocular Exclusion Criteria (Study Eye):

1. History of anterior uveitis only (without associated uveitis that affected the posterior segment).
2. Presence of a vitreous hemorrhage.
3. Uveitis with infectious etiology.
4. Intraocular inflammation associated with a condition other than non-infectious uveitis (e.g., intraocular lymphoma).
5. Current infectious diseases of the cornea and conjunctiva, mycobacterial infections of the eye, or fungal diseases of ocular structures.
6. Subjects with ACIOL (Anterior Chamber Intraocular Lens) or rupture of the posterior lens capsule.
7. Diagnosis of any form of glaucoma or ocular hypertension at screening, unless the study eye is being treated with ≤2 intraocular pressure (IOP)-lowering medications and/or has been previously treated with an incisional surgical procedure resulting in stable IOP in the normal range (10 to 21 mmHg).
8. Intraocular pressure \>21 mmHg or concurrent therapy at screening with \>2 IOP-lowering pharmacologic agents in the study eye.
9. Any eye surgery within 12 weeks prior to Day 1 of the study.
10. Subjects who are unable to attend scheduled follow-up visits throughout the 12-month study.
11. Has a significant media opacity precluding evaluation of retina and vitreous in the study eye.

Where this trial is running

Plano, Texas

• Texas Retina Associates — Plano, Texas, United States (Recruiting)

Study contacts

• Study coordinator: Tara Keesling, COA

Conditions Uveitis; Uveitis, Posterior; Uveitis, Anterior; Uveitis, Intermediate