NCT05592717 A Study of YUTIQ® 0.18 mg Intravitreal Implant for the Management of Chronic Non-infectious Uveitis
| NCT ID | NCT05592717 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Tianjin Medical University |
| Condition | Uveitis |
| Study Type | OBSERVATIONAL |
| Enrollment | 15 participants |
| Start Date | 2023-01-05 |
| Primary Completion | 2025-11-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 15 participants in total. It began in 2023-01-05 with a primary completion date of 2025-11-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This project is designed to evaluate the efficacy of YUTIQ® 0.18 mg intravitreal implant for the management of chronic non-infectious uveitis.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05592717 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Uveitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05592717 currently recruiting?
Yes, NCT05592717 is actively recruiting participants. Contact the research team at xiaomzh@126.com for enrollment information.
Where is the NCT05592717 trial being conducted?
This trial is being conducted at Tianjin, China.
Who is sponsoring the NCT05592717 clinical trial?
NCT05592717 is sponsored by Tianjin Medical University. The trial plans to enroll 15 participants.