Efficacy and safety of intravitreal Ziv-Aflibercept for the treatment of macular edema: a systematic review and meta-analysis

Munayco-Guillén F.; García-Roa M.; Vázquez-Membrillo M.; Pichardo-Rodríguez R. · Archivos de la Sociedad Espanola de Oftalmologia (2026) · DOI: 10.1016/j.oftal.2026.502465

Resumen

Background and objective: Intravitreal Ziv-Aflibercept (ZA-IV) is a recombinant fusion protein used to treat macular diseases. Several studies have demonstrated its efficacy and safety. The objective was to evaluate the efficacy and safety of ZA-IV in the treatment of diabetic macular edema (DME) and macular edema secondary to retinal vein occlusion (RVO). Materials and methods: Systematic review with meta-analysis (PROSPERO: CRD42024542788), with searches in PubMed, EMBASE, and Web of Science up to April 2024. Observational studies and randomized controlled trials (RCTs) were included. Efficacy was determined by best-corrected visual acuity (BCVA) and central macular thickness (CMT). Safety was assessed based on the reports in the studies. Risk of bias was assessed using the Robins-I and Cochrane RoB 2.0 tools. Results: Of 503 studies, 8 observational studies and 5 RCTs were included. In DME, RCTs showed a reduction in CMT (−105 μm; 95% CI: −129.8 to −80.3; I2: 0%) and in BCVA a LogMAR reduction (−0.29; 95% CI: −0.36 to −0.21; I2: 0%). Observational studies in DME showed a reduction in CMT (−108 μm; 95% CI: −133 to −83.1; I2: 34%) and in BCVA a LogMAR reduction (−0.2; 95% CI: −0.26 a −0.14; I2: 0%). In RVO, RCTs showed a reduction in CMT (−230 μm; 95% CI: −367 to −94; I2: 46%). Observational studies in EMSOV showed a reduction in GMC (−160 μm; 95% CI: −257 to −64; I2: 74%) and in BCVA (best corrected visual acuity) a reduction in LogMAR (−0.2; 95% CI: −0.26 to −0.14; I2: 50%). No serious ocular or systemic adverse effects were reported. Conclusion: ZA-IV demonstrated efficacy and is potentially safe for the treatment of EMD and EMSOV.