Using YUTIQ® implant to treat chronic non-infectious uveitis

An Observational Study of YUTIQ (Fluocinolone Acetonide Intravitreal Implant 0.18 mg) for the Management of Chronic Non-infectious Uveitis

This study is testing whether the YUTIQ® implant can help people with chronic non-infectious uveitis better than traditional steroid treatments.

Quick facts

• Study type: Observational
• Enrollment: 15 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Tianjin Medical University (Academic / other)
• Locations: 1 site (Tianjin, Tianjin Municipality)
• Trial ID: NCT05592717 on ClinicalTrials.gov

What this trial studies

This observational study evaluates the efficacy of the YUTIQ® 0.18 mg intravitreal implant in managing chronic non-infectious uveitis. Patients are divided into two groups: one receiving the YUTIQ implant and the other receiving traditional glucocorticoid therapies. The study follows participants for up to three years, assessing outcomes such as visual acuity, inflammation levels, and corticosteroid dosage changes. The methodology adheres to ethical standards and includes informed consent from all participants.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 70 with active unilateral or bilateral non-infectious uveitis affecting the posterior segment.

Not a fit: Patients with corneal or lens opacity that obstructs fundus visualization or those with a history of certain neurological conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a more effective management option for patients suffering from chronic non-infectious uveitis.

How similar studies have performed: While this approach is being evaluated, similar studies using intravitreal implants for uveitis have shown promise, suggesting potential for success.

Eligibility criteria

Inclusion Criteria:

1. Male or female in good general health at 18 to 70 years of age.
2. Presence of unilateral or bilateral non-infectious uveitis affecting the posterior segment
3. Patients have active inflammation before Yutiq treatment. Subject meets at least 1 of the following criteria: 1. ≥1+ anterior chamber cell and/or ≥1+ vitreous haze. 2. Fluorescein angiography demonstrates leakages. 3. OCT images showing the macular edema. 4. The times of relapse in one year are equal to or greater than 3.
4. Steroids and immunosuppressive agents were discontinued within 3 months after Yutiq injection.

Exclusion Criteria:

1. Subject with corneal or lens opacity that precludes visualization of the fundus or that likely requires cataract surgery during the duration of the trial.
2. Subject with a history of neurologic symptoms suggestive of central nervous system demyelinating disease.
3. Prior intravitreal treatment with Retisert®, ILUVIEN®, or YUTIQ® (0.18 mg) within 36 months prior to Day 1.
4. Prior intravitreal treatment with OZURDEX® within 12 weeks prior to Day 1. Prior intravitreal treatment with Triesence® or TRIVARIS™ (triamcinolone) within 12 weeks prior to Day 1.
5. Peri-ocular or subtenon steroid treatment within 12 weeks prior to Day 1.
6. Media opacity precluding evaluation of retina and vitreous (eg, vitreous hemorrhage).
7. Hypersensitivity to any of the ingredients contained in YUTIQ®.
8. Any other systemic or ocular condition which, in the judgment of the Investigator, could make the subject inappropriate for study enrollment.
9. Pregnant or nursing females; females of childbearing potential who are unwilling or unable to use an acceptable method of contraception as outlined in the protocol from at least 14 days prior to Day 1 until the final study visit.

Where this trial is running

Tianjin, Tianjin Municipality

• Tianjin Medical University Eye Hospital — Tianjin, Tianjin Municipality, China (Recruiting)

Study contacts

• Study coordinator: xiaomin Zhang

Conditions Uveitis; YUTIQ