Outcomes of Over 40,000 Eyes Treated for Diabetic Macula Edema in Routine Clinical Practice: A Systematic Review and Meta-analysis

Introduction: We investigated effectiveness and safety outcomes of diabetic macula edema (DME) treatment in routine clinical practice.

Methods: A literature search was conducted of peer-reviewed articles published from January 2011 to September 2021. Studies of DME treatment in real-world practice of at least 6 months with at least 50 eyes at baseline were included. Randomized controlled trials (RCTs) were excluded. The primary outcome for this meta-analysis was change in visual acuity (VA) 12 months after starting treatment.

Results: Of 3034 initially identified studies, 138 met selection criteria, representing more than 40,000 eyes. The mean 12-month VA gain was 4.6 letters (95% CI 3.7, 5.4; baseline 58.6) for vascular endothelial growth factor inhibitors (anti-VEGF), 4.4 (2.5, 6.3; baseline 54.2) for steroids, and 2.1 (- 1.2, 5.3; baseline 63.6) for macular laser. Australian and New Zealand studies had better baseline VA when initiating treatment compared with Asia, Europe, and North America, translating to better VA at 12 months. Fewer anti-VEGF injections were delivered in real-world practice than registrational RCTs. Neither systemic nor ocular safety was consistently reported.

Conclusions: Intravitreal anti-VEGF or steroids for DME generally led to visual gains in real-world practice but these were less impressive than RCTs, with undertreatment and differences in baseline characteristics likely contributing factors.

Keywords: Diabetic macula edema; Meta-analysis; Observational; Outcomes; Real-world data; Systematic review; Treatment.