Aflibercept or ranibizumab for diabetic macular edema

Abstract Background: Vascular endothelial growth factor (VEGF) is the primary substance involved in retinal barrier breach. VEGF overexpression may cause diabetic macular edema (DME). Laser photocoagulation of the macula is the standard treatment for DME; however, recently, intravitreal anti-VEGF injections have surpassed laser treatment. Our aim was to evaluate the efficacy of intravitreal injections of aflibercept or ranibizumab for managing treatment-naive DME. Methods: This single-center, retrospective, interventional, comparative study included eyes with visual impairment due to treatment-naive DME that underwent intravitreal injection of either aflibercept ۲ mg/۰.۰۵ mL or ranibizumab ۰.۵ mg/۰.۰۵ mL at Al-Azhar University Hospitals, Egypt between March ۲۰۲۳ and January ۲۰۲۴. Demographic data and full ophthalmological examination results at baseline and ۱, ۳, and ۶ months post-injection were collected, including the best-corrected distance visual acuity (BCDVA) in logarithm of the minimum angle of resolution (logMAR) notation, slit-lamp biomicroscopy, dilated fundoscopy, and central subfield thickness (CST) measured using spectral-domain optical coherence tomography. Results: Overall, the ۹۶ eyes of ۹۶ patients with a median (interquartile range [IQR]) age of ۵۷ (۱۰) (range: ۲۰–۷۴) years and a male-to-female ratio of ۱:۲.۷ were allocated to one of two groups with comparable age, sex, diabetes mellitus duration, and presence of other comorbidities (all P >۰.۰۵). There was no statistically significant difference in baseline diabetic retinopathy status or DME type between groups (both P >۰.۰۵). In both groups, the median (IQR) BCDVA significantly improved from ۰.۷ (۰.۸) logMAR at baseline to ۰.۴ (۰.۱) logMAR at ۶ months post-injection (both P = ۰.۰۰۱), with no statistically significant difference between groups at all follow-up visits (all P >۰.۰۵). The median (IQR) CST significantly decreased in the aflibercept group from ۳۴۷ (۱۶۶) µm at baseline to ۱۸۰ (۲۳۳) µm at ۶ months post-injection, and it decreased in the ranibizumab group from ۳۶۰ (۱۸۰) µm at baseline to ۱۹۰ (۲۲۴) µm at ۶ months post-injection (both P = ۰.۰۰۱), with no statistically significant differences between groups at all follow-up visits (all P >۰.۰۵). No serious adverse effects were documented in either group. Conclusions: Ranibizumab and aflibercept were equally effective in achieving the desired anatomical and functional results in patients with treatment-naive DME in short-term follow-up without significant differences in injection counts between both drugs. Larger prospective, randomized, double-blinded trials with longer follow-up periods are needed to confirm our preliminary results.