Abstract

BackgroundIntravitreal injection of anti-vascular endothelial growth factor (VEGF) has become first line therapy for diabetic macular edema. This study evaluated the efficacy and safety of intravitreal injection of Ranibizumab (IVR) as pre-treatment for pars plana vitrectomy in proliferative diabetic retinopathy (PDR) patients with vitreous hemorrhage.MethodsThis pilot randomized controlled trial included 48 eyes with vitreous hemorrhage resulting from active PDR. Eyes were treated with IVR 1 or 3 days before vitrectomy or a sham subconjunctival injection 3 days before surgery. The occurrence of new tractional retinal detachment (TRD), total operation time, and intraoperative findings were compared. The concentrations of VEGF and connective tissue growth factor (CTGF) in aqueous humor and plasma collected at the time of IVR and vitrectomy were determined by ELISA.ResultsNone of the patients who received IVR experienced new TRD. Ranibizumab injection improved intraoperative outcomes. The mean concentrations of VEGF in aqueous humor were significantly lower after than before IVR in patients who received IVR 1 and 3 days before surgery (P < 0.001 each). The CTGF/log10 (VEGF) ratio was significantly higher after than before IVR in patients who received IVR 3 days before vitrectomy (P = 0.046).ConclusionPreoperative IVR is an effective and safe strategy for the surgical treatment of severe PDR combined with vitreous hemorrhage. IVR 1 and 3 days before surgery can significantly reduce VEGF content in aqueous humor and effectively improve intraoperative conditions without causing TRD.Trial registrationThis study was registered with the Chinese Clinical Trial Registry. Name of the registry: Exploratory analysis of effect of intravitreal ranibizumab as pre-treatment for pars plana vitrectomy in proliferative diabetic retinopathy. Trial registration number: ChiCTR-ONC-16009520. Date of registration: October 20, 2016. URL of trial registry record: http://www.chictr.org.cn/searchprojen.aspx

Highlights

  • Intravitreal injection of anti-vascular endothelial growth factor (VEGF) has become first line therapy for diabetic macular edema

  • Ranibizumab causes transient vasoconstriction, which may clinically resemble vascular regression. This "regression" of retinal neovascularization can occur in proliferative diabetic retinopathy (PDR), clinical observations suggest that responses to anti-VEGF therapy are spontaneously reversed [8, 9]

  • Functional and anatomical results None of the patients receiving Intravitreal injection of Ranibizumab (IVR) 1 and 3 days before vitrectomy experienced a new occurrence of tractional retinal detachment (TRD) after

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Summary

Introduction

Intravitreal injection of anti-vascular endothelial growth factor (VEGF) has become first line therapy for diabetic macular edema. This study evaluated the efficacy and safety of intravitreal injection of Ranibizumab (IVR) as pre-treatment for pars plana vitrectomy in proliferative diabetic retinopathy (PDR) patients with vitreous hemorrhage. Conventional therapy for PDR combined with vitreous hemorrhage consists of vitrectomy plus retinal photocoagulation [2]. Ranibizumab is a recombinant, monoclonal antibody fragment that inhibits VEGF [6], and intravitreal injection of ranibizumab (IVR) before vitrectomy has been reported to be an effective adjunct treatment for PDR [7]. Ranibizumab causes transient vasoconstriction, which may clinically resemble vascular regression This "regression" of retinal neovascularization can occur in PDR, clinical observations suggest that responses to anti-VEGF therapy are spontaneously reversed [8, 9]

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