ILUVIEN ® in diabetic macular edema that persists or recurs despite treatment: Results from the Retina.pt ® RIVER audit.

Purpose: Persistent diabetic macular edema (DME) remains a problem in clinical practice, with many patients having a suboptimal response to the standard of care (SOC). Evidence supports the long-term efficacy of intravitreal fluocinolone acetonide (FAc) implant (ILUVIEN ^® ) in patients that have responded sub-optimally, although there is still scarce data from real-world Portuguese practices. We aimed to monitor the current SOC in selected Portuguese practices prior to FAc implantation and then assess the long-term effectiveness and safety of the FAc implant.
Settings: The study included patient data from five Portuguese public hospitals.
Design: This was a non-interventional, multicenter audit of data collected from Retina.pt registry from patients with persistent or recurrent DME despite treatment.
Methods: Outcome measures included changes in best-corrected visual acuity (BCVA), central macular thickness (CMT), and intraocular pressure (IOP). Results were compared at regular times over 36 months.
Results: This study included 222 eyes from 152 patients. A significant decrease in BCVA (P < 0.001) and a significant increase in CMT (P = 0.013) were observed prior to FAc. A significant increase in BCVA was registered at 6 months after FAc implant administration (P < 0.001), which was maintained during follow-up. No relevant changes in IOP were observed. Treatment burden was reduced as a result of treatment with FAc (P < 0.001 for anti-VEGF, corticosteroids, or both treatments) in the full population.
Conclusions: In Portuguese practice, data showed that pre-FAc implantation, some patients did not respond to SOC treatment and/or they were undertreated. Following FAc implant administration, there were rapid, sustained, long-term visual and anatomical improvements, and a marked reduction in treatment burden.
Competing Interests: Declaration of conflicting interestsJoão Paulo Castro Sousa has received consulting fees from Alimera Sciences, Alcon, Bayer, and Novartis; has received payment or honoraria for lectures, presentations, speakers bureaus and educational events from Abvie, Alimera Sciences, Alcon, Bayer, Novartis, and Roche; was supported for attending meetings and/or travel by Alimera Sciences, Alcon, Bayer, and Novartis; and has participated on Data Safety Monitoring Boards or Advisory Boards for Alimera, Alcon, and Novartis.Susana Penas has received consulting fees from Alimera Sciences, Bayer, Novartis, and Roche.Rufino Silva has participated on Advisory Boards for ABBVIE, Alimera Sciences, Novartis, Bayer, Théa; Novo Nordisk, and Roche.Ângela Carneiro has participated on Advisory Boards for Alimera Sciences, Allergan, Bayer, Novartis, and Roche.Angelina Meireles has received consulting fees and support for attending meetings and travel from AbbVie; has received payment for presentations from Alcon; has participated on an Advisory Board from Alimera Sciences; and has received support for attending meetings and travel from Alimera Sciences.