Abstract
Purpose :
As a class effect, corticosteroids can increase intraocular pressure in some patients, but few studies have looked at long term outcomes due to the short lifespan of most treatment options. However, the 0.19 mg fluocinolone acetonide (FAc) implant US FDA label mandated steroid challenge is designed to mitigate the risk of uncontrolled IOP. Here, we report the IOP outcomes of the PALADIN phase IV study, including mean IOP and time to IOP elevation, in the 36 months post-FAc treatment to determine the impact of the 0.19 mg FAc implant on IOP and functional outcomes within this population.
Methods :
Full analysis population includes 202 eyes from 159 patients enrolled with CI-DME that received FAc and were followed for up to 36 months. Eyes were followed at day 1, day 7, month 2, and quarterly from month 3 up to month 36. IOP and best corrected visual acuity (BCVA) were reported at each visit and used to determine outcomes post-FAc.
Results :
In the full population, most eyes had a mean IOP of ≤ 25 mmHg in the 36 months post-FAc which was similar to that of pre-FAc baseline values (96.6%=post-FAc; 99.0%=baseline). A breakdown of the population showed subtle changes in the frequency distribution that was not dramatically affected over the 36 months post-FAc. For those eyes that experienced an IOP elevation > 25 mmHg, > 30 mmHg, or were prescribed IOP lowering medications, median time to these events were 9.1, 13.7, and 11.8 months respectively. To determine which eyes may be more susceptible to IOP events post-FAc, subgroups were created and the incidence of IOP events were compared to the full population. Eyes with the no additional treatment post-FAc and baseline BCVA ≤ 20/40 were all associated with less incidence of IOP events compared to the full population. Finally, BCVA was not significantly impacted in the eyes experiencing an IOP elevation >30 mmHg or requiring IOP lowering therapy.
Conclusions :
In the 36 months post-FAc, the IOP distribution was marginally affected with over 96% of eyes showing a mean IOP ≤ 25 mmHg at any study visit. In eyes who had an IOP elevation > 30 mmHg or required IOP lowering therapy, these events did not affect long term vision when compared to baseline. Finally, a lower incidence of IOP events post-FAc were noted in the eyes with better vision and fewer additional treatments.
This abstract was presented at the 2022 ARVO Annual Meeting, held in Denver, CO, May 1-4, 2022, and virtually.