Status:
RECRUITING
A Study of YUTIQ® 0.18 mg Intravitreal Implant for the Management of Chronic Non-infectious Uveitis
Lead Sponsor:
Tianjin Medical University
Conditions:
Uveitis
YUTIQ
Eligibility:
All Genders
18-70 years
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.
Detailed Description
Approval of the study was obtained from the hospital's ethical committee. The study design and methodology followed the tenets of Declaration of Helsinki. All patients were provided with written infor...
Eligibility Criteria
Inclusion Criteria:
- Male or female in good general health at 18 to 70 years of age.
- Presence of unilateral or bilateral non-infectious uveitis affecting the posterior segment
- 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.
- Steroids and immunosuppressive agents were discontinued within 3 months after Yutiq injection.
Exclusion Criteria:
- Subject with corneal or lens opacity that precludes visualization of the fundus or that likely requires cataract surgery during the duration of the trial.
- Subject with a history of neurologic symptoms suggestive of central nervous system demyelinating disease.
- Prior intravitreal treatment with Retisert®, ILUVIEN®, or YUTIQ® (0.18 mg) within 36 months prior to Day 1.
- 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.
- Peri-ocular or subtenon steroid treatment within 12 weeks prior to Day 1.
- Media opacity precluding evaluation of retina and vitreous (eg, vitreous hemorrhage).
- Hypersensitivity to any of the ingredients contained in YUTIQ®.
- Any other systemic or ocular condition which, in the judgment of the Investigator, could make the subject inappropriate for study enrollment.
- 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.
Key Trial Info
Start Date :
January 5 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
November 1 2026
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT05592717
Start Date
January 5 2023
End Date
November 1 2026
Last Update
July 3 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Tianjin Medical University Eye Hospital
Tianjin, Tianjin Municipality, China, 300000