Abstract
Purpose :
PALADIN is a 3-year prospective, phase IV study aimed at determining the incidence of IOP related events in patients treated with the 0.19 mg fluocinolone acetonide (FAc) implant on label. Corticosteroids, including FAc, may lead to elevated intraocular pressure (IOP). Six eyes required IOP lowering surgery due to FAc or neovascular glaucoma (NVG) and the long-term outcomes are reported here.
Methods :
202 eyes from 159 patients with CI-DME were treated with the 0.19 mg FAc implant on label requiring a prior steroid challenge without significant IOP elevation. Assessments, including IOP and best corrected visual acuity (BCVA), were taken at baseline, day 7, month 2, month 3, and then every 3 months up to 3 years.
Results :
Six eyes required IOP lowering surgery (All Eyes) due to FAc exposure (n=3; FAc Induced) and development of NVG (n=3; NVG). Baseline IOP was 14.7±1.0 (mean±SE), 16.0±1.5, and 13.3±0.7 mmHg which peaked to 33.8±4.5, 29±2.6, and 38.7±8.4 mmHg at 12, 9, and 12 months for All Eyes, FAc Induced, and NVG groups respectively. IOP was normalized by surgery with median time to surgery at 20, 20, and 19 months for All Eyes, FAc Induced, and NVG groups respectively. All Eyes were prescribed IOP lowering medication at an average of 3.0±1.3 medications per eye with FAc Induced eyes requiring fewer medications than NVG eyes (2.0 vs. 4.0; p<0.05) but with longer duration of therapy (17.7 vs. 2.6 months; p<0.01). Time to IOP lowering medication post-FAc was 18.3±7.7, 15.6±10.1, and 19.6±6.2 months (mean±SD) for All Eyes, FAc Induced, and NVG groups respectively. For All Eyes, best corrected visual acuity (BCVA) was maintained from baseline to last study visit (+7.3 Letters; NS) with a significant reduction in center subfield thickness (CST) (-143 µm; p<0.05).
Conclusions :
Throughout PALADIN, a small proportion of eyes (1.5%) required IOP lowering surgery due to FAc induced ocular hypertension. Regardless of the cause (FAc Induced or NVG), All Eyes saw normalization of IOP by the end of the study with maintenance of visual acuity and significant improvement in anatomical outcomes. Although the risk for IOP lowering surgery in this population was small, eyes that did require surgery still had favorable outcomes in the management of their DME.
This abstract was presented at the 2023 ARVO Annual Meeting, held in New Orleans, LA, April 23-27, 2023.