Two-year interim safety results of the 0.2 μg/day fluocinolone acetonide intravitreal implant for the treatment of diabetic macular oedema: The observational PALADIN study
British Journal of Ophthalmology
inflammation; intraocular pressure; macula; retina; treatment other
© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. Background: The 0.2 μg/day fluocinolone acetonide (FAc) implant delivers continuous, low-dose, intravitreal corticosteroid for the treatment of diabetic macular oedema (DMO). This ongoing, 3-year, observational clinical trial provides long-term, real-world'safety results for the FAc implant in DMO. Methods: This 24-month interim analysis of a prospective, observational study investigated patients with DMO receiving the commercially available intravitreal 0.2 μg/day FAc implant. The primary outcome was incidence of intraocular pressure (IOP)-lowering procedures. Other IOP-related signals and their relationship to previous corticosteroid exposure, best-corrected visual acuity, central subfield thickness (CST), ocular adverse events and frequency of other treatments were also measured. Results: Data were collected from 95 previously steroid-challenged patients (115 study eyes) for up to 36 months pre-FAc and 24 months post-FAc implant. Mean IOP for the overall population remained stable post-FAc compared with pre-FAc implant. IOP-related procedures remained infrequent (two IOP-lowering surgeries pre-FAc; two trabeculoplasties and four IOP-lowering surgeries post-FAc). Mean visual acuity was stable post-FAc (mean improvement of 1-3 letters) and fewer DMO treatments were required per year following FAc implant. Mean CST was significantly reduced at 24 months post-FAc implant (p<0.001) and the percentage of patients with CST ≤300 μm was significantly increased (p=0.041). Conclusion: Few IOP-related procedures were reported during the 24 months post-FAc implant. Positive efficacy outcomes were noted after treatment, with stabilisation of vision and reduction in inflammation, demonstrated by CST. The FAc implant has a favourable benefit-risk profile in the management of DMO, especially when administered after a prior steroid challenge. Trial registration number: NCT02424019.
Mansour, S. E., Kiernan, D., Roth, D., Eichenbaum, D., Holekamp, N., Kaba, S., & Werts, E. (2020). Two-year interim safety results of the 0.2 μg/day fluocinolone acetonide intravitreal implant for the treatment of diabetic macular oedema: The observational PALADIN study. British Journal of Ophthalmology, (). http://dx.doi.org/10.1136/bjophthalmol-2020-315984