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Among a subset of patients in the phase IV PALADIN study, there was improved visual acuity, improved macular thickness, and reduced treatment burden among patients treated with the intravitreal fluocinolone acetonide 0.2 µg (Iluvien implant) for DME.
By Vanessa Caceres
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.
Dr. Mansour presented information from a subset of 60 patients who had received 12 months of treatment with intravitreal fluocinolone acetonide. The demographics of the group were similar to the overall study population, he said.
Their mean baseline visual acuity was 62.3 based on ETDRS. There also was a mean baseline central subfield thickness (CST) of 400.6 µm and a mean IOP of 15.45 mm Hg.
Patients from the subset and the overall group had various prior treatments with anti-vascular endothelial growth factor (anti-VEGF) medications, laser, or steroid injections.
“There are a few areas with some [treatment] differences between the two groups, but it’s too early to assess what this might be,” Dr. Mansour added.
When those with a visual acuity of 20/40 or better or 20/40 or worse are subdivided, there was a stabilization of vision and a visual acuity increase followed by a stabilization, respectively, Dr. Mansour said.
“In both groups, there is a statistically significant reduction in treatment burden,” Dr. Mansour said.
For those with a visual acuity of 20/40 or better, one treatment was required every 10.20 months. In those within the 20/40 or worse group, one treatment was required every 6.90 months.
At 12 months, there was a greater proportion of patients with a visual acuity of 20/40 or better who had the Iluvien implant.
“With regard to macular thickness, there’s a fairly rapid reduction following the implant,” Dr. Mansour said. At 3 months, 38.46% of patients were at 300 µm or less; by 6 months, it was 35.71%; at 12 months, it was 44.64%.
Although a slight numeric increase in IOP occurred after treatment, it was not of statistical significance. There also was no statistically significant increase in IOP events or the need for glaucoma surgery.
However, a larger number of patients needed IOP-lowering medications after the implant–20.9% versus 7.5% before treatment, Dr. Mansour said.
More than half of patients did not require additional DME treatments at 12 months, but 38.1% required intravitreal anti-VEGF medications, 4.6% required laser treatment, and 4% needed steroid treatment.
Sam Edward Mansour, MD
This article was adapted from a presentation that Dr. Mansour delivered on behalf of the PALADIN trial at the 2017 American Academy of Ophthalmology meeting. Dr. Mansour is a clinical investigator for Alimera Sciences.