Ranibizumab or Aflibercept Monotherapies in Treatment-Naive Eyes with Diabetic Macular Edema: A Head-to-Head Comparison in Real-Life Experience.

OBJECTIVES: To compare the functional and anatomical outcomes of ranibizumab and aflibercept monotherapies given according to a pro re nata (PRN) protocol in treatment-naive eyes with diabetic macular edema (DME) in a real-life clinical setting.

MATERIALS AND METHODS: The medical charts of treatment-naive patients with center-involved DME retrieved from our institutional database were reviewed in this retrospective cohort study. A total of 512 treatment-naive eyes with DME underwent either ranibizumab (Group I; 308 eyes) or aflibercept (Group II; 204 eyes) monotherapy and 462 patients were included. The primary outcome was visual gain over 12 months.

RESULTS: The mean number of intravitreal injections within the first year was 4.34±1.83 and 4.39±2.12 in Group I and II, respectively (p=0.260). The mean best corrected visual acuity (BCVA) improvement at 12 months was +5.7 and +6.5 ETDRS letters in Group I and II, respectively (p=0.321). However, among eyes with a BCVA score less than 69 ETDRS letters (54% of the study population), visual gain was more prominent in Group II (+15.2 vs. +12.1 ETDRS letters; p<0.001). Statistically significant decreases in central foveal thickness were observed with both ranibizumab and aflibercept monotherapy (p<0.001), with no significant difference between the groups. (p=0.148).

CONCLUSIONS: No statistically significant difference was found in visual outcomes at 12-month follow-up between ranibizumab and aflibercept monotherapies using a PRN protocol, although there was a tendency toward slightly better functional and anatomic prognosis in the aflibercept arm.