Archivos de la Sociedad Espanola de Oftalmologia · 2026
Efficacy and safety of intravitreal Ziv-Aflibercept for the treatment of macular edema: A systematic review and meta-analysis.
СтатьяСистематический обзорМетаанализНазвание и аннотация: Перевод пока не подготовлен
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Munayco-Guillén F, García-Roa M, Vázquez-Membrillo M, Pichardo-Rodríguez R
Аннотация
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.
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.