A study to evaluate the safety and efficacy of YUTIQ® 0.18 mg intravitreal implant for the management of chronic non-infectious posterior segment uveitis (intraocular inflammation) that has responded to previous steroid therapy.
This is a prospective, phase 4, open-label, uncontrolled, 2-year follow-up study to evaluate the safety and efficacy of YUTIQ® (fluocinolone acetonide intravitreal implant) 0.18 mg for the management of chronic non-infectious posterior segment uveitis (intraocular inflammation) that has responded to previous steroid therapy. Patients will receive YUTIQ® 0.18 mg as an intravitreal injection in the designated study eye and will be followed for 24 months after treatment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
125
YUTIQ® 0.18 mg as an intravitreal injection in the designated study eye.
Retina Consultants of Orange County
Fullerton, California, United States
Change in BCVA
• Mean change from baseline in BCVA letter score in the study eye measured by EDTRS.
Time frame: Month 6
Change in CST
• Mean change from baseline central subfield thickness (CST, also known as central foveal thickness) measured by SD-OCT in the study eye.
Time frame: Month 6
Recurrence of non-infectious inflammation
• Time to recurrence of non-infectious inflammation in the study eye defined as an increase in CST.
Time frame: Months 1, 3, 6, 12, 18, and 24
Presence of vascular leakage
• Presence of vascular leakage as measured by wide field fluorescein angiography.
Time frame: Months 1, 3, 6, 12, 18, and 24.
Resolution of macular edema
• Proportion of subjects with resolution of macular edema (central subfield thickness CST) as measured by SD OCT.
Time frame: Months 1, 3, 6, 12, 18, and 24
Change in BCVA letter score
• Mean change from baseline in BCVA letter score in the study eye measured by EDTRS.
Time frame: Day 14 and at Months 1, 3, 12, 18, and 24
Change from baseline in CST
• Mean change from baseline in CST measured by SD-OCT in the study eye.
Time frame: Months 1, 3, 12, 18, and 24
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Macula and Retina Institute
Glendale, California, United States
California Eye Specialists Medical Group
Pasadena, California, United States
Retinal Consultants Medical Group
Sacramento, California, United States
Retina Associates of Colorado
Lakewood, Colorado, United States
Advanced Research
Coral Springs, Florida, United States
Retina Specialists of Tampa
Wesley Chapel, Florida, United States
Marietta Eye Clinic
Marietta, Georgia, United States
Retinal Vitreal Consultants Ltd.
Chicago, Illinois, United States
Illinois Retina Associates, S.C.
Oak Park, Illinois, United States
...and 13 more locations