An injectable fluocinolone acetonide intravitreal insert in patients with chronic non-infectious uveitis affecting the posterior segment of the eye: Effects on macular oedema at 6 months

Session Details

Session Title: Free Paper Session 10: Uveitis

Session Date/Time: Friday 08/09/2017 | 11:00-12:30

Paper Time: 12:12

Venue: Room 111

First Author: : C.Pavesio UK

Co Author(s): :                                 

Abstract Details

Purpose:

Uveitis is often a chronic disease requiring long-term medical therapy. This study tested the hypothesis that an injectable fluocinolone acetonide intravitreal insert (FAI) delivering microdoses for 36 months can reduce the proportion of subjects who have a recurrence of uveitis over an extended time period after a single administration. Treatment effect on macular oedema at 6 months was also investigated

Setting:

This was a phase III, multi-national, multi-centre, randomized, masked, safety and efficacy study of an FAI versus sham intravitreal injection

Methods:

The study included subjects who had been diagnosed with unilateral or bilateral chronic non-infectious uveitis affecting the posterior segment of the eye for at least 12 months prior to randomisation. Following the injection subjects are being evaluated through 36 months Recurrence was defined as: 1) ≥2 step increase in the number of cells in the anterior chamber per high powered field (1.6 × using a 1-mm beam), compared with baseline or any visit time point prior to Month 6 OR 2) An increase in the vitreous haze of ≥2 steps, compared with baseline or any visit time point prior to Month 6 OR 3) A deterioration in visual acuity of at least 15 letters best-corrected visual acuity (BCVA), compared with baseline or any visit time point prior to Month 6. Resolution of macular oedema at 6 months was measured by optical coherence tomography imaging

Results:

A total of 129 subjects were enrolled in the study (all randomised population), 87 subjects and 42 subjects in the FAI and sham injection treatment groups, respectively. All randomised subjects were included in the ITT efficacy analysis and safety populations. The proportion of subjects who had a study eye uveitis recurrence within 6 months of treatment was significantly lower in the FAI treatment group compared with the sham injection treatment group (ITT population: 24 [27.6%] subjects and 38 [90.5%] subjects in the FAI treatment group and the sham injection treatment group, respectively (OR: 24.94; 95% CI: 8.04, 77.39; p<0.001). In the study eye of the FAI treatment group, of the 51 study eyes who had macular oedema at baseline, 34 (66.7%) study eyes no longer had macular oedema at 6 months. In the sham injection treatment group, of the 28 study eyes who had macular oedema at baseline, 11 (39.3%) study eyes no longer had macular oedema at 6 months; 1 study eye was not evaluable. The study is still open; follow-up will continue through 36 months

Conclusions:

The FAI very effectively reduced the number of uveitis recurrences compared to sham injection. Administration of a single FAI resulted in a 3-fold reduction in the rate of recurrence at 6 months compared to the sham. In addition, the proportion of subjects who had resolution of macular oedema at 6 months was higher in the FAI treatment group compared with the sham injection treatment group. This treatment is a very promising method to provide long-term inflammation control with an office-based injection procedure as shown through both subjective and objective clinical parameters.

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