A study to evaluate the safety and efficacy of a fluocinolone acetonide intravitreal (FAI) insert in the management of subjects with chronic non-infectious uveitis affecting the posterior segment of the eye.
This was a phase 3, multicenter, randomized, masked, controlled study to evaluate the safety and efficacy of an injectable FAI insert for the management of subjects with chronic non-infectious uveitis affecting the posterior segment of the eye. Subjects were randomized to receive either a sham injection or the FAI insert and were observed for 1 year following treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
12
Intravitreal sham injection
Yutiq 0.05 mg contains 0.05 mg FA and was designed to deliver FA into the vitreous humor for at least 24 weeks. Yutiq 0.05 mg was administered to the study eye by injection through the pars plana using a pre-loaded applicator with a 25-gauge needle.
EyePoint Study Site
Waltham, Massachusetts, United States
Percentage of Subjects With Recurrence of Uveitis in the Study Eye at Week 24
Recurrence was defined as: * An increase in the vitreous haze of ≥2 steps compared to baseline or any visit time point prior to the Week 24 visit; or * A deterioration in visual acuity of at least 15 letters BCVA compared to baseline or any visit time point prior to the Week 24 visit.
Time frame: Week 24
Percentage of Subjects With Recurrence of Uveitis in the Study Eye at Week 52
Recurrence was defined as: * An increase in the vitreous haze of ≥2 steps compared to baseline or any visit time point prior to the Week 24 visit (or the Week 52 visit); or * A deterioration in visual acuity of at least 15 letters BCVA compared to baseline or any visit time point prior to the Week 24 visit (or the Week 52 visit).
Time frame: Week 52
Percentage of Subjects With Recurrence of Uveitis in the Fellow Eye at Weeks 24 and 52
Recurrence was defined as: * An increase in the vitreous haze of ≥2 steps compared to baseline or any visit time point prior to the Week 24 visit (or the Week 52 visit); or * A deterioration in visual acuity of at least 15 letters BCVA compared to baseline or any visit time point prior to the Week 24 visit (or the Week 52 visit).
Time frame: Weeks 24 and 52
Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) Letter Score in the Study Eye at Weeks 24 and 52
The BCVA was measured according to the standard procedure originally developed for Early Treatment Diabetic Retinopathy Study (ETDRS). The ETDRS letter score calculated when 20 or more letters were read correctly at 4.0 meters; the visual acuity letter score was equal to the total number of letters read correctly at 4.0 meters plus 30. The score ranges from 0 (worse) to 100 (best). Higher scores indicate positive outcome measure.
Time frame: Weeks 24 and 52
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Number of Recurrences of Uveitis Within 24 and 52 Weeks
Recurrence was defined as: An increase in the vitreous haze of ≥2 steps compared to baseline or any visit time point prior to the Week 24 visit (or the Week 52 visit); or A deterioration in visual acuity of at least 15 letters BCVA compared to baseline or any visit time point prior to the Week 24 visit (or the Week 52 visit).
Time frame: Weeks 24 and 52
Time to Recurrence of Uveitis Through Weeks 24 and 52
Recurrence was defined as: An increase in the vitreous haze of ≥2 steps compared to baseline or any visit time point prior to the Week 24 visit (or the Week 52 visit); or A deterioration in visual acuity of at least 15 letters BCVA compared to baseline or any visit time point prior to the Week 24 visit (or the Week 52 visit).
Time frame: Weeks 24 and 52
Number of Adjunctive Treatments Required to Treat Recurrences of Uveitis at 24 and 52 Weeks
Recurrence was defined as: An increase in the vitreous haze of ≥2 steps compared to baseline or any visit time point prior to the Week 24 visit (or the Week 52 visit); or A deterioration in visual acuity of at least 15 letters BCVA compared to baseline or any visit time point prior to the Week 24 visit (or the Week 52 visit). In the event of a uveitis recurrence in either eye, peri-ocular or intraocular corticosteroid injections, or topical medications administered as first line local therapy.
Time frame: Weeks 24 and 52
Percentage of Subjects With Recurrence of Iridocyclitis in the Study Eye Compared to Baseline at 24 and 52 Weeks
Iridocyclitis was defined as a \>2-step increase in anterior chamber cells per high-power field (HPF) (1.6\*using a 1-millimeter beam).
Time frame: Weeks 24 and 52
Percentage of Subjects With Resolution of Macular Edema at Day 28 and Months 2, 3, 6 and 12
The macular edema was measured by spectral-domain - optical coherence tomography (SD-OCT) imaging.
Time frame: At Day 28 and Months 2, 3, 6 and 12