Ranibizumab or Aflibercept for Diabetic Macular Edema: One-Year Comparison of Real-World Outcomes from Fight Retinal Blindness! Registry.

Abstract

Purpose : To compare the 12 months treatment outcomes of ranibizumab and aflibercept for diabetic macular edema (DME) in routine clinical practice.

Methods : This was a retrospective analysis of data from a prospectively designed observational registry: the Fight Retinal Blindness! Project. Treatment-naïve eyes that started either ranibizumab (0.5mg) or aflibercept (2mg) for DME from 1 December 2013 to 1 June 2018 were identified. The primary outcome was the mean change in visual acuity (VA in logMAR letters) from baseline to 12 months.

Results : We identified 383 eyes (Ranibizumab – 166, Aflibercept – 217) of 291 patients. Eyes of patients in the aflibercept group had a lower mean VA (mean difference [MD] -3.1 letters) and a thicker maculae (MD +26μm) than those of ranibizumab at baseline which was not significantly different (Table 1). Patients on ranibizumab were older (MD +2.7 years). The adjusted MD in VA change and central subfield thickness (CST) reduction were +1 letter (1.4 for aflibercept versus 0.4 for ranibizumab, p=0.4) and -30 microns (-85 versus -55, p<0.01) in eyes with initial VA ≥20/40 and +3 letters (10.6 versus 7.6, p<0.01) and -46 microns (-148 versus -102, p<0.02) in those presenting with VA ≤20/50. Eyes in the aflibercept group received more injections over 12 months, median (Q1, Q3) of 8 (6, 9), than the ranibizumab group, 6 (4, 8), though this difference was not significant (p=0.13). Treatment switches, albeit low, were more frequent from ranibizumab to aflibercept than vice versa. Significantly more eyes in the aflibercept group were lost to follow-up within 12 months (21% versus 9% ranibizumab, P<0.01).

Conclusions : Both drugs were beneficial for DME (Figure 1). Aflibercept-treated eyes, which had borderline worse vision and thicker maculae at baseline, had larger reductions in CST after 12 months of treatment. Larger gains in VA was observed with aflibercept treatment when the initial VA was ≤20/50.

This is a 2020 ARVO Annual Meeting abstract.

 

 

Figure 1. Line graphs showing (A) the mean predicted VA (solid lines) in logMAR letters (y-axis) and CST (dashed lines) in μm (z-axis); (B) the difference in the mean change in VA and (C) CST between ranibizumab (purple) and aflibercept (blue) treated eyes over 12-month in all eyes irrespective of whether they completed, switched (visits at the time of switch) or did not complete 12-month observation from starting treatment.