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Thiago Leite Albuquerque, Gian S Pierozzi, Anna Carolina C Araújo, Nicolau H Neto, Taisa B Carregal, Marcia C Martins, Janaina C Souza, Gabriel A Carlos, Arnaldo Furman Bordon; Comparative, Randomized, Double Blinded Study of the Use of Anti-VEGF in Patients with Vitreous Hemorrhage or Tractional Retinal Detachment Secondary to Diabetic Retinopathy. Invest. Ophthalmol. Vis. Sci. 2014;55(13):4391.
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Compare the rebleeding rate after pars plana vitrectomy with or without the use of anti-VEGF intraoperatively and postoperatively
Prospective, masked, comparative, double blinded study. Ethics committee approved. Patients affected by non-clearing vitreous hemorrhage (VH) secondary to proliferative diabetic retinopathy were submitted to pars plana vitrectomy (PPV) and divided in two groups where they received 0.05ml of bevacizumab or 0.05 ml of BSS at the final of the procedure. Six weeks after surgery patients assigned to anti-VEGF received the same dose and patients assigned to BSS received a sham injection. The surgeon and the evaluating physicians were masked to the vial content. The injecting physician was masked to the visits and surgery. Major inclusion criteria were: non-clearing vitreous hemorrhage and/or traction retinal detachment eligible for surgical repair and age greater than 18 years-old. Main exclusion criteria were: patients with uncontrolled systemic hypertension, thromboembolic events in the past 3 months, use of anticoagulants other than aspirin, previous PPV or VH due to cause other than diabetic retinopathy. Complete ophthalmic examination and blood pressure measurement were performed at baseline and 7, 30, 60, and 90 days after the surgery. This trial is registered at https://eudract.ema.europa.eu - 2013-001128-20
29 eyes of 27 patients met the inclusion criteria. Patient`s age, blood pressure, glicemic control between the two groups were well balanced. 11 eyes were assigned to the bevacizumab group and 18 to the BSS group. None out of 11 eyes of the bevacizumab group showed rebleeding after PPV. Five out 18 eyes of the BSS group presented with rebleeding at some point at the follow-up after PPV. High blood pressure was statistically significant associated with increased rebleeding rate at D30. At D90 the bevacizumab group showed statistically significant less rebleeding rate.
Our study showed that the use of bevacizumab intraoperativelly and after six weeks of the surgery reduced the rebleeding rate after PPV for VH or TRD due to PDR when compared to BSS. Further studies with larger sample are warranted to demonstrate the value of this approach
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