None listed
Conditions
Interventions
This is a 3 year multicenter, randomized, double-masked controlled study to evaluate the safety and efficacy of an Intravitreal Fluocinolone Acetonide (0.59 and 2.1 mg) implant in patients with unilateral or bilateral non-infectious uveitis affecting the posterior segment of the eye. Eligible subjects will receive either a 0.59mg or 2.1mg implant (assigned according to a randomization code) surgically inserted in one eye. In patients with bilateral disease, the more severely affected eye will b
This is a 3 year multicenter, randomized, double-masked controlled study to evaluate the safety and efficacy of an Intravitreal Fluocinolone Acetonide (0.59 and 2.1 mg) implant in patients with unilateral or bilateral non-infectious uveitis affecting the posterior segment of the eye. Eligible subjects will receive either a 0.59mg or 2.1mg implant (assigned according to a randomization code) surgically inserted in one eye. In patients with bilateral disease, the more severely affected eye will be implanted. Subjects will be followed for a period of 3 years, the approximate time period over which the implants are designed to release FA.
Sponsors
Bausch & Lomb (Rochester)
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
6 Years to No maximum
Healthy volunteers
No
Inclusion criteria
One or both eyes having a history of non-infectious uveitis affecting the posterior segment of the eye > 1 yr requiring either systemic or sub-tenon injections of corticosteroid, study eye must be clinically quite at the time of implantation and have visual acuity of at least 1.4logMar units.
Exclusion criteria
Allergy to FA, history of only posterior segment uveitis without vitritis or macula edema, history of iritis only and no vitreous cells or haze, uveitis of infectious etiology, vitreous hemorrhage, presence of toxoplasmosis scar in study eye, peripheral retinal detachment in area of implantation, media opacity precluding ophthalmic evaluation, presence or history or uncontrolled IOP, ocular surgery within 3 months of enrollment, subjects requiring chronic systemic corticosteroid or immunosuppressive therapy for non-ocular conditions, subjects tested positive for HIV, pregnant or lactating females, females of childbearing potential considering becoming pregnant during the course of the study and not taking effective contraception, subjects whose special risks outweigh the potential benefits of participating in the study, subjects who are unlikely to comply with study protocol and visit schedule, subjects who are currently enrolled in any other IND or have participated in an IND within 1 month of enrollment.
Outcome results
None listed