In the phase IV PALADIN study, 53% of patients required no further treatment after 12 months when treated with the intravitreal fluocinolone acetonide 0.2 µg implant (Iluvien, Alimera Sciences) for diabetic macular edema (DME).
PALADIN, or phase IV IOP Signals With Iluvien, is an ongoing study at 41 U.S. study locations with an enrollment target of 153 patients. Patients are eligible for treatment with the Iluvien implant based on U.S. prescribing information.
The study objectives focus on intraocular pressure (IOP) safety data and assessing the patient experience with the implant following prior treatment with the course of steroids, according to Sam Edward Mansour, MD. The steroid use did not result in a significant IOP elevation.
“PALADIN will also provide information on the treatment burden with up to 3 years of pre-[Iluvien] implant data in randomized subjects to include DME treatments, visual acuity, and IOP data,” Dr. Mansour said.