[New perspectives in the approach to diabetic macular edema. Aflibercept therapy].
The VISTA and VIVID trials were conducted to compare the safety and efficacy of two intravitreal injection (IVI) regimens of aflibercept versus macular laser photocoagulation for the treatment of diabetic macular edema (DME). These double-masked, phase III clinical trials randomized (461/402) patients with DME to receive either 2mg aflibercept IVI every 4 weeks (2q4) or 2mg aflibercept IVI every 8 weeks (2q8) after 5 initial monthly doses vs macular laser photocoagularion. The primary efficacy endpoint was the mean change in best corrected visual acuity (BCVA) from baseline to week 52. Secondary efficacy endpoints were the change in central retinal thickness (CRT), the proportion of patients who gained ≥10 amd ≥15 Early Treatment Diabetic Retinopathy Study (ETDRS) letters, and the change in the National Eye Institute Visual Function Questionnaire (NEI VFQ-25) in near and distance vision. The mean BCVA gains in the 2q4 and 2q8 groups versus the laser group were 12.5 and 10.7 versus 0.2 letters (p<0.0001) in VISTA, and 10.5 and 10.7 versus 1.2 letters (p<0.0001) in VIVID. The proportions of patients gaining ≥ 15 letters and the proportion of patients with an improvement of > 2 levels in the severity of diabetic retinopathy was significant in the treatment groups versus the laser group. Mean reductions in CRT in the 2q4 and 2q8 groups vs the laser group were 185.9 and 183.1 versus 73.3 μm (p<0.0001) in VISTA, and 195.0 and 192.4 versus 66.2 μm (p<0.0001) in VIVID. The incidences of ocular and nonocular adverse events were similar in all groups. In conclusion, IIV aflibercept demonstrated statistically significant superiority in improvement in BCVA and reduction in DME over laser, with similar efficacy in the 2q4 and 2q8 groups in VISTA and VIVID.
Servicio de Oftalmología, Universidad de Castilla La Mancha, Albacete, España; Vicepresidente de la Sociedad Española de Retina y Vítreo (SERV), España; Director Médico del Instituto Europeo de la Retina (IER) Baviera, España; Red Temática de Investigación Cooperativa OFTARED (RD12/0034/0011), Instituto de Salud Carlos III, Madrid, España. Electronic address: josemaria.ruiz@uclm.es.
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Ruiz-Moreno
D020533:Angiogenesis Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D002318:Cardiovascular Diseases / Q000139:chemically induced; D017326:Clinical Trials, Phase III as Topic; D003930:Diabetic Retinopathy / Q000150:complications / Q000188:drug therapy* / Q000503:physiopathology; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D006801:Humans; D007141:Immunoglobulin Fc Fragments / Q000009:adverse effects / Q000627:therapeutic use; D053685:Laser Therapy; D008269:Macular Edema / Q000150:complications / Q000188:drug therapy* / Q000503:physiopathology; D015337:Multicenter Studies as Topic; D016032:Randomized Controlled Trials as Topic; D040262:Receptors, Vascular Endothelial Growth Factor / Q000627:therapeutic use*; D011993:Recombinant Fusion Proteins / Q000009:adverse effects / Q000627:therapeutic use*; D015861:Retinal Neovascularization / Q000188:drug therapy* / Q000209:etiology / Q000601:surgery; D012171:Retinal Vessels / Q000187:drug effects; D016896:Treatment Outcome; D014792:Visual Acuity / Q000187:drug effects
D020533:Angiogenesis Inhibitors; D007141:Immunoglobulin Fc Fragments; D011993:Recombinant Fusion Proteins; C533178:aflibercept; D040262:Receptors, Vascular Endothelial Growth Factor
Aflibercept; Antiangiogenic; Antiangiogenico; Diabetic macular edema; Diabetic retinopathy; Edema macular diabetico; Fotocoagulacion laser; Intravitreal injection; Inyeccion intravitrea; Laser photocoagulation; Retinopatia diabetica