Safety and Efficacy of an Injectable Fluocinolone Acetonide Intravitreal (FAI) Insert (NCT05070728) | Clinical Trial Compass
TerminatedPhase 3
Safety and Efficacy of an Injectable Fluocinolone Acetonide Intravitreal (FAI) Insert
Stopped: No longer pursuing indication
United States12 participantsStarted 2021-10-13
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Male or non-pregnant female at least 18 years of age at time of consent.
✓. One or both eyes had a history of recurrent non-infectious uveitis affecting the posterior segment of the eye (intermediate, posterior, or panuveitis) with or without anterior uveitis \>1 year duration.
✓. During the 52 weeks prior to enrollment (Day 1), the subject must have received treatment for uveitis in the study eye with:
✓. Systemic corticosteroid or other systemic therapies for at least 12 consecutive or non-consecutive weeks, AND/OR
✓. at least 2 intra- or peri-ocular administrations of corticosteroid in the study eye, OR
✓. the study eye has experienced recurrence of uveitis at least 2 separate times requiring systemic, intra- or peri-ocular injection of corticosteroid.
✓. At the time of enrollment (Day 1), the study eye has \<10 anterior chamber cells/HPF (high power field) and a vitreous haze ≤ grade 2.
✓. Visual acuity of study eye ≥15 letters on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart.
Exclusion criteria
✕. History of posterior uveitis only that is not accompanied by vitritis or macular edema.
✕. History of iritis only associated with no vitreous cells, anterior chamber cells, or vitreous haze at Day 1.
✕. Uveitis with infectious etiology.
What they're measuring
1
Percentage of Subjects With Recurrence of Uveitis in the Study Eye at Week 24