PALADIN study: Navigating IOP-lowering surgery in DME patients for optimal outcomes
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Key takeaways:
- IOP-lowering surgery did not have a significant impact on DME management outcomes.
- The PALADIN study showed no significant vision loss risk after IOP-lowering surgery in DME patients.
In the dynamic landscape of diabetic macular edema management, the PALADIN study continues to offer helpful insights into the outcomes of IOP-lowering surgery after treatment with Iluvien.
The comprehensive 3-year phase 4 study with 202 eyes of 159 patients reaffirms the successful patient outcomes associated with IOP-lowering surgery and highlights key factors influencing these outcomes.
The study aims to simplify the nuanced landscape of IOP-lowering surgery and its impact on DME management in this specific patient population. Out of the 202 eyes enrolled, eight eyes required surgery, three of which were unrelated to DME therapy.
After surgery, the PALADIN study reaffirmed real-world experience with Iluvien (fluocinolone acetonide intravitreal implant 0.19 mg, Alimera Sciences): successful management of DME with good anatomical and visual outcomes after normalization of IOP in all patients. The median time to surgery was 19 months, during which IOP-lowering medications were administered to all eyes for an average duration of 8.61 ± 2.03 months.
Eyes that experienced increased IOP due to the steroid required fewer IOP-lowering medications than eyes with neovascular glaucoma (NVG), albeit for a more extended period. Notably, vision was maintained or improved after IOP-lowering surgery in all eyes, including fluocinolone acetonide-induced and NVG-induced cases. While variations were observed, with changes of +8.2 letters (steroid-induced IOP-lowering surgery) and +0.7 letters (NVG eyes) from baseline, respectively, these differences were not statistically significant.
The PALADIN study found that the risk for vision loss after IOP-lowering surgery in the DME population is not significant. It is also important to note that, for patients undergoing IOP-lowering surgery, there is no significant impact on DME management outcomes. The successful normalization of IOP, coupled with the overall maintenance or improvement in vision after surgery, underscores the safety and efficacy of IOP-lowering surgery within the context of Iluvien implant treatment.
Physicians who manage patients with DME can benefit from the valuable insights provided by the PALADIN study, guiding their decisions in treatment planning. The study not only addresses concerns related to IOP-lowering surgery but also assists retina specialists in tailoring DME treatment algorithms for each individual patient. By integrating findings from this research, physicians can navigate potential risks with confidence and customize interventions to optimize patient care.
For more information:
David S. Chin Yee, MD, is a retina specialist at Georgia Retina.
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Chin Yee DS, et al. Outcomes in eyes requiring IOP-lowering surgery after treatment with the 0.19-mg fluocinolone acetonide implant for DME: The PALADIN study. Presented at: American Academy of Ophthalmology meeting; Nov. 3-6, 2023; San Francisco.
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