An intravitreal fluocinolone acetonide implant (Iluvien, Alimera Sciences) provided patients with diabetic macular edema (DME) with anatomic and visual improvements at the 6-month evaluation in a phase IV study of the device’s efficacy, anatomic, and safety outcomes.
Patients with the worst baseline vision had the greatest improvements compared with those with better initial vision. The initial data suggested a decreased need for additional treatments for DME after implantation of the device
The PALADIN Real-World Observational Study is a prospective, non-randomized, open-label trial conducted to collect data from patients with DME who had been treated according to the U.S. indication to assess intraocular pressure (IOP) signals in this patient population.
Because the study dose of 0.2 mcg/day of fluocinolone acetonide is the only treatment for DME that continuously provides therapy for 3 years with 1 administration, the study will provide important information related to treatment burden, according to Jay Prensky, MD.
The 38-center study included 159 patients who were considered eligible for the implant based on the prescribing information. The best-corrected visual acuity (BCVA), central subfield thickness (CST), IOP, and lens status were recorded in 112 patients. Changes from the baseline BCVA and CST were analyzed at the 6-month evaluation. All patients had been treated for DME with steroids, anti-vascular endothelial growth factor (anti-VEGF) therapy, or laser.
Dr. Prensky, in private practice in Camp Hill, PA, reported the results of the interim analysis from 78 patients (51.3% male; mean age, 66.5 years) who completed the 6-month safety evaluation; 94 eyes were included in the safety assessment and 91 eyes in the visual assessment. The mean duration of DME was 5.3 years, mean BCVA 60.7 letters, mean CST 390.7 µm, and baseline IOP 14 mm Hg.