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

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 (NCT05486468) is a Phase 3 interventional studying Uveitis and Uveitis, Posterior, sponsored by Texas Retina Associates. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

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

What Stage of Research Is This?

Phase 3 trials confirm efficacy and safety in large patient groups (often 300–3,000+) and form the evidence base for an FDA approval submission. For Uveitis, Phase 3 studies typically randomize participants between the investigational treatment and either a placebo or current standard of care. A successful Phase 3 result is the threshold most treatments need to clear before regulatory approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 30 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: General Who May Qualify: 1. Male or non-pregnant female in good general health at least 18 years of age, understands the language of the willing to sign a consent form, and is willing and able to provide written willing to sign a consent form 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. Who Should NOT Join This Trial: General Who Should NOT Join This Trial: 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. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

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.

Treatments Being Tested

DRUG

Yutiq 0.18 MG Drug Implant

YUTIQ ® (fluocinolone acetonide intravitreal implant) 0.18 mg, for intravitreal injection

OTHER

Sham Injection

Sham injection

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Texas Retina Associates

Plano, Texas, United States

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT05486468), the sponsor (Texas Retina Associates), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT05486468 clinical trial studying?

The Use of Two YUTIQ versus Sham for Treatment of Chronic Non Infectious Intraocular Inflammation Affecting the Posterior Segment (TYNI Trial) The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT05486468?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT05486468?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT05486468. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT05486468. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.