Preoperative Intravitreal Bevacizumab for Tractional Retinal Detachment Secondary to Proliferative Diabetic Retinopathy: Prospective Randomized Clinical Trial of the Pan-American Collaborative Retina Study (PACORES) Group*

Abstract Purpose To assess the effectiveness and safety of an intravitreal injection of 1.25 mg of bevacizumab (IVB) as a preoperative adjunct to small-gauge pars plana vitrectomy (PPV) compared to PPV alone in eyes with tractional retinal detachment (TRD) secondary to proliferative diabetic retinopathy (PDR). Methods This prospective, double-masked, randomized, multicenter, active-controlled clinical trial enrolled 224 eyes of 224 patients between November 2013 and July 2015. All eyes underwent a baseline exam including best corrected visual acuity (BCVA), color photos, optical coherence tomography (OCT) and fluorescein angiography (FA). Data were collected on intraoperative bleeding, total surgical time, early ( P results Two hundred and fourteen (214 eyes) patients were randomized in a 1:1 ratio to PPV plus IVB ([study group] 102 eyes) or PPV plus sham ([control] 112 eyes). Iatrogenic retinal breaks were noted intraoperatively in 35 eyes (34.3%) in the study group, and 66 eyes (58.9%) in the control group ( P =0.001). Grade 2 intraoperative bleeding was noted in 32 (31.3%) eyes in the study group and 58 (51.7 %) eyes in the control group ( P =0.001). Endodiathermy was necessary in 28 (27.4 %) eyes in the study group, compared with 75 (66.9 %) eyes in the control group ( P =0.0001). Mean surgical time was 71.3±32.1 minutes in the study group and 83.6±38.7 minutes in the control group ( P =0.061). Conclusion Preoperative IVB seems to reduce intraoperative bleeding, improving surgical field visualization, and reducing intraoperative and postoperative complications.