Abstract
Purpose :
A steroid challenge is mandated prior to the use of the 0.19 mg fluocinolone acetonide implant (FAc), however it is unclear which steroid is superior in identifying intraocular pressure (IOP) risk. Here we looked at the positive predictive value (PPV) of the steroid challenge by quantifying the incidence of IOP response post-FAc. FAc is indicated for the treatment of diabetic macular edema in eyes that have previously been treated with a course of corticosteroids without clinically significant rise in IOP. We computed the PPV of the steroid challenge for the full population but also for eyes that received 1 or > 1 dexamethasone implant (DEX), the most used steroid for challenge. The time course of IOP over 36 months (M) and visual acuity outcomes were also determined.
Methods :
Full analysis population includes 202 eyes from 159 patients enrolled with CI-DME that received FAc and were followed for up to 36M. Subjects were followed at day 1, week 1, 2M, and quarterly from 3M up to 36M. PPV was calculated by computing the percentage of eyes whose IOP remained ≤ 25 mmHg at any time (Max PPV) or by the 36M time point (Last-PPV) post-FAc who also passed the steroid challenge (≤ 25 mmHg post challenge) pre-FAc.
Results :
The Max PPV of all eyes was 78.0% with the Last PPV being 96.9%. For eyes with 1 DEX or > 1 DEX Max PPV values were 85.7% and 68.3%, and Last PPV values were 98.7% and 96.3% respectively with twice as many eyes receiving only 1 Dex prior to FAc. 20.3% of eyes received IOP lowering medication with a peak mean increase in IOP of 2.12 mmHg at 9M (p<0.0001) and 0.88 mmHg (NS) at 36M. Over the course of 36M, 87% of eyes had IOP ≤ 20 mmHg, 97% had IOP ≤ 25 mmHg, and 99% had IOP ≤ 30 mmHg. Eyes that received any prior steroid challenge or prior DEX all gained vision by 36M (+4.5 letters, p<0.02; +12.7, NS).
Conclusions :
The steroid challenge pre-FAc is highly predictive of the IOP response post-FAc and not dependent on steroid choice or number of Dex. This is evident by the small change in mean IOP of the full population and that 97% of eyes had IOP ≤ 25 mmHg over the 36M post-FAc. Similarly, the steroid choice had little impact on visual acuity gains at 36 months with the full population experiencing significant vision improvement by nearly a line and eyes receiving a DEX challenge were able to maintain vision.
This abstract was presented at the 2022 ARVO Annual Meeting, held in Denver, CO, May 1-4, 2022, and virtually.