Two year interim findings from the PALADIN phase IV study indicate that a continuous supply of fluocinolone acetonide using the ILUVIEN implant has favourable outcomes in people living with chronic Diabetes-related Macular Edema1. ILUVIEN is a micro-implant in the eye designed to provide a slow and consistent supply of fluocinolone acetonide, a drug which is used to suppress inflammation associated with Diabetes-related Macular Edema.
Diabetes-related Macular Edema is characterised by retinal thickening within two disc diameters (disc diameters refers to the size of the optic nerve head) of the central retina. In total, 95 individuals (115 eyes) participated in this study, which achieved a significant reduction (P < 0.001) in subretinal foveal thickness from 383um at baseline to 340um at 24 months post-implantation. A central subfoveal thickness less than 300um and moving towards normal anatomy was achieved in 42% of the patient cohort2.
Best-corrected visual acuity (BCVA) was used to stratify the participants into two groups of 20/40 vision or better and worse than 20/40 vision; that an individual sees at 20 feet what a person with normal vision sees at 40 feet. The 39 eyes placed in the 20/40 vision or better category had a baseline BCVA of 76.9 letters as measured on the Snellen eye chart, while the 76 eyes in the worse than 20/40 vision category had a baseline BCVA of 53.4 letters2.
Over the 24 month period, both groups experienced improvements in their BCVA, increasing to 77.8 letters and 56.4 letters in the 20/40 vision or better category and worse than 20/40 vision category respectively. Lead author Victor H. Gonzalez, MD, who presented these results at the virtual Association for Research in Vision and Ophthalmology (ARVO) conference remarked that the ILUVIEN implant resulted in “stabilized or improved vision, with one or less supplemental treatments per year in the majority of subjects, with over 50% of eyes receiving one or less treatments per year to obtain the vision gains”2.
These positive results are consistent in the patient cohort with no severe adverse effects recorded, thus suggesting the ILUVIEN implant containing fluocinolone acetonide as a promising treatment strategy for Diabetes-related Macular Edema. Additionally, as the majority (51%) of patients received one treatment or fewer, this new treatment protocol facilitates recipients in living more independent lives without the need to attend frequent appointments for therapy administration.
- Gonzalez V. Two-year outcomes from the PALADIN Phase 4 study: Anatomic/functional changes and reduced treatment frequency associated with 0.19 mg of fluocinolone acetonide implant (FAc)with persistent or recurrent diabetic macular edema,” Presented at: Association for Research in Vision and Ophthalmology annual meeting; May 6, 2020 (virtual meeting).
- Practice Update: ARVO 2020: Two-Year PALADIN Outcomes Affirm Benefits of Fluocinolone Acetonide Implant for Diabetic Macular Edema. Available at: https://www.practiceupdate.com/content/arvo-2020-two-year-paladin-outcomes-affirm-benefits-of-fluocinolone-acetonide-implant-for-diabetic-macular-edema/102131. Accessed June 2020.