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

NCT05486468 | Recruiting Phase 3 FDA Drug

• 1 other identifier: TRA-TYNI-22-001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Secondary Outcomes (1)

• Recurrence rate of uveitis at the 12-month visit

  12 months

Study Arms (2)

Treatment Arm

EXPERIMENTAL

This group will receive two YUTIQ implants at day 1.

Drug: Yutiq 0.18 MG Drug Implant

Control Arm

SHAM COMPARATOR

This group will receive two sham injections at day 1.

Other: Sham Injection

Interventions

Yutiq 0.18 MG Drug Implant DRUG

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

Treatment Arm

Sham Injection OTHER

Sham injection

Control Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Vitreous haze grade ≥ 2 based on the standardization of uveitis nomenclature (SUN) criteria.
• Less than 10 anterior chamber cells/high power field determined by slit lamp examination.
• Not planning to undergo elective ocular surgery during the study.

You may not qualify if:

• 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).
• Presence of a vitreous hemorrhage.
• Uveitis with infectious etiology.
• Intraocular inflammation associated with a condition other than non-infectious uveitis (e.g., intraocular lymphoma).
• Current infectious diseases of the cornea and conjunctiva, mycobacterial infections of the eye, or fungal diseases of ocular structures.
• Subjects with ACIOL (Anterior Chamber Intraocular Lens) or rupture of the posterior lens capsule.
• 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).
• Intraocular pressure \>21 mmHg or concurrent therapy at screening with \>2 IOP-lowering pharmacologic agents in the study eye.
• Any eye surgery within 12 weeks prior to Day 1 of the study.
• Subjects who are unable to attend scheduled follow-up visits throughout the 12-month study.
• Has a significant media opacity precluding evaluation of retina and vitreous in the study eye.

Sponsors & Collaborators

• Texas Retina Associates: lead
• Eye Point Pharmaceuticals: collaborator
• ANI Pharmaceuticals: collaborator

Study Sites (1)

Texas Retina Associates

Plano, Texas, 75075, United States

RECRUITING

MeSH Terms

Conditions

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

Interventions

Fluocinolone Acetonide; Drug Implants; salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Uveal Diseases; Eye Diseases; Panuveitis

Intervention Hierarchy (Ancestors)

Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Delayed-Action Preparations; Dosage Forms; Pharmaceutical Preparations

Central Study Contacts

Tara Keesling, COA

CONTACT

9725969222; tkeesling@texasretina.com

Jodi Creighton

CONTACT

9725969222; jcreighton@texasretina.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: The subject and the examining doctor will be masked to the treatment the subject receives on day 1.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 1 year, prospective, randomized, collaborative study.

Study Record Dates

• First Submitted: August 1, 2022
• First Posted: August 3, 2022
• Study Start: October 5, 2022
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: August 11, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)