Table 1. . Treatment and sham group comparisons through 12 months of relapse rate, cumulative number of reactivations, time to first recurrence, best corrected visual acuity change from baseline, resolution of intraretinal fluid, number of additional treatments required and safety profile.
| Fluocinolone acetonide insert group | Sham group | |
|---|---|---|
| Recurrence rate at 6 months | 28% | 91% |
| Recurrence rate at 12 months | 38% | 98% |
| Median time to recurrence (days) | 378.0 | 70.5 |
| Recurrences per study eye (median) | 0.7 | 2.5 |
| ≥15-letter decrease in BVCA | 14% | 31% |
| Additional systemic treatment | 19% | 40% |
| Additional local therapy | 7% | 62% |
| Absence of intraretinal fluid at 12 months | 71% | 48% |
| Decrease in central subfield thickness at 12 months (μm) | 82.5 ± 69.4 | 65.8 ± 52.3 |
| Cataract | 33% | 12% |
| Increased in IOP (mmHg) | 1.3 ± 57 | 0.2 ± 4.17 |
| Increased in IOP from baseline 5 mmHg | 48.3% | 33.3% |
| Increased in IOP from baseline 12 mmHg | 18.4% | 9.5% |
| IOP lowering treatment | 26% | 26% |
BVCA: Best corrected visual acuity; IOP: Intraocular pressure.
Data taken from [10].