Ziv-aflibercept versus bevacizumab administration prior to diabetic vitrectomy: a randomised and controlled trial.

PURPOSE: To compare the effectiveness of intravitreal ziv-aflibercept (IVZ) to intravitreal bevacizumab (IVB) administered preoperatively to patients undergoing pars plana vitrectomy (PPV) for severe manifestations of proliferative diabetic retinopathy (PDR). DESIGN: Randomised clinical trial (RCT). METHODS: Two hundred and six patients with PDR-related complications requiring PPV were randomised into one of two treatment groups: Group A received IVZ (1.25 mg/0.05 mL) 1-10 days before PPV, while Group B received IVB (1.25 mg/0.05 mL) 1-10 days before PPV. The primary outcome was best-corrected visual acuity (BCVA) at 6 months follow-up. Secondary outcome measures were perioperative tractional retinal detachment (TRD) rates, surgical times, intraoperative and postoperative complications and incidence of unplanned PPV during the 6 month study interval. RESULTS: One hundred and seventy three subjects underwent PPV and completed the 6-month follow-up interval. Group A subjects had better BCVA at 6 months (p=0.0035), shorter surgical times (p=0.0013) and were less likely to have a recurrence of vitreous haemorrhaging in the postoperative period (p=0.0101) when compared with subjects in Group B. There were no significant differences among the treatment groups with regards to baseline characteristics, perioperative TRD development, intraoperative complications and incidence of unplanned PPV during the 6 month study interval. CONCLUSIONS: This RCT demonstrated better final visual outcomes, shorter operating times and less vitreous haemorrhage recurrences in the postoperative period when subjects received IVZ compared to IVB prior to PPV for the treatment of PDR-related complications.

Bevacizumab before Diabetic Vitrectomy: A Clinical Trial Assessing 3 Dosing Amounts.

PURPOSE: To evaluate the optimal dosing of preoperative intravitreal bevacizumab (IVB) in patients undergoing pars plana vitrectomy (PPV) for manifestations of proliferative diabetic retinopathy (PDR). DESIGN: Randomized clinical trial. PARTICIPANTS: Two hundred six patients with severe manifestations of PDR underwent PPV at a single university-based hospital. METHODS: Patients were randomized into 1 of 3 treatment groups: group A received 0.625 mg IVB (0.025 ml) 1 to 10 days before PPV, group B received 1.25 mg IVB (0.05 ml) 1 to 10 days before PPV, and group C received 2.5 mg IVB (0.1 ml) 1 to 10 days before PPV. MAIN OUTCOME MEASURES: The primary outcome was best-corrected visual acuity (BCVA) at 6 months. Secondary outcome measures were rates of perioperative tractional retinal detachment (TRD) development, intraoperative and postoperative complications, and incidence of unplanned PPV at 6 months. RESULTS: One hundred sixty-seven patients underwent PPV and completed 6 months of follow-up. There were no significant differences between treatment groups regarding baseline characteristics, final BCVA, intraoperative complications, postoperative complications, or unplanned PPV rates. There were no patients in group A (0.0%), 3 patients in group B (7.0%), and 5 patients in group C (8.5%) who demonstrated perioperative TRD after IVB administration, but before PPV (P = 0.0283). This difference was significant between groups A and B (P = 0.0494) and between groups A and C (P = 0.0080). CONCLUSIONS: This randomized clinical trial demonstrated that patients receiving the 0.625-mg dose of IVB before PPV for the treatment of PDR-related manifestations showed similar visual acuity, but a lower incidence of perioperative TRD development compared with patients receiving the 1.25-mg and 2.5-mg doses. Clinicians should consider adopting the lowest effective dose, 0.625 mg, into clinical practice. The current study is limited by the lack of a control group receiving no IVB before PPV.

Preoperative Bevacizumab Administration in Proliferative Diabetic Retinopathy Patients Undergoing Vitrectomy: A Randomized and Controlled Trial Comparing Interval Variation.

PURPOSE: To assess the optimal interval of preoperative intravitreal bevacizumab (IVB) administration in diabetic subjects undergoing pars plana vitrectomy (PPV) for severe manifestations of active proliferative diabetic retinopathy (PDR). DESIGN: Randomized clinical trial. METHODS: One hundred and fifty-six patients with PDR-related complications requiring PPV were prospectively randomized into 1 of 2 treatment groups: Group A received IVB (2.5 mg/0.1 mL) 1-3 days before PPV, while Group B received IVB (2.5 mg/0.1 mL) 5-10 days before PPV. The primary outcome was best-corrected visual acuity (BCVA) at 6 months follow-up. Secondary outcome measures were intraoperative surgery time, intraoperative complications, postoperative complications, and incidence of unplanned PPV at 6 months follow-up. RESULTS: One hundred and twenty-five subjects underwent PPV and completed the 6-month follow-up interval. Group B patients had better final BCVA (P = .033) and were less likely to have a postoperative complication (P = .018) when compared to Group A patients. The mean difference in final BCVA between groups was 0.22 logMAR (95% confidence interval: 0.02-0.43, P = .017). Group A was 3.90 (95% confidence interval: 1.08-17.31, P = .046) times more likely to have a loss of 1 or more logMAR lines of final BCVA when compared to Group B. There were no significant differences among the treatment groups with regard to baseline features, intraoperative surgery time, intraoperative complications, and incidence of unplanned PPV during the study interval. CONCLUSIONS: This randomized clinical trial demonstrated better postoperative outcomes at 6 months when subjects received preoperative IVB 5-10 days before PPV compared to 1-3 days for the treatment of PDR-related complications.