RECRUITINGOBSERVATIONAL
A Study of YUTIQ® 0.18 mg Intravitreal Implant for the Management of Chronic Non-infectious Uveitis
An Observational Study of YUTIQ (Fluocinolone Acetonide Intravitreal Implant 0.18 mg) for the Management of Chronic Non-infectious Uveitis
About This Trial
This project is designed to evaluate the efficacy of YUTIQ® 0.18 mg intravitreal implant for the management of chronic non-infectious uveitis.
Who May Be Eligible (Plain English)
Who May Qualify:
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.
Who Should NOT Join This Trial:
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.
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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.
Treatments Being Tested
DRUG
Yutiq
YUTIQ® 0.18 mg as an intravitreal injection in the designated study eye.
Locations (1)
Tianjin Medical University Eye Hospital
Tianjin, Tianjin Municipality, China