Tractional Retinal Detachment Secondary to Proliferative Diabetic Retinopathy Clinical Trial
Official title:
Pre-Operative Intravitreal Bevacizumab for Tractional Retinal Detachment Secondary to Proliferative Diabetic Retinopathy: Results of the Pan-American Collaborative Retina Study (PACORES) Group
The purpose of this is study is to assess the efficacy of pre-operative intravitreal bevacizumab (IVB) (Genentech, South San Francisco CA) in improving visual acuity, reducing operative time, complications, intra-operative and post-operative hemorrhage following small gauge pars plana vitrectomy (PPV) (23-gauge, 25-gauge or 27-gauge ) compared to small gauge PPV (23-gauge, 25-gauge or 27-gauge) alone in eyes with tractional retinal detachment (TRD) secondary to proliferative diabetic retinopathy (PDR). Hypothesis: Preoperative IVB may be beneficial for membrane dissection in diabetic tractional retinal detachment with minimally invasive vitreoretinal surgery (23-gauge transconjunctival sutureless vitrectomy [TSV]). In addition, post-operative rebleeding may be decreased.
This will be a prospective, randomized, active-controlled study of 224 eyes of patients with
the diagnosis of TRD secondary to PDR. Participants will be screened for eligibility.
Eligible patients will be examined at baseline to determine their ocular condition and
randomized into 2 arms. Patients will be randomized in a 1:1 ratio to the study arm.
1. Control arm: PPV without pre-operative bevacizumab (Sham injection).
2. Study arm: Pre-operative bevacizumab (3-5 days) before PPV.
In the study arm, an intravitreal bevacizumab injection at a dose of 1.25 µg/0.05 mL will be
scheduled 3 to 5 days before minimally invasive vitreoretinal surgery (MIVS).
The purpose of the current study is to determine the effectiveness and safety of an
intravitreal injection of 1.25 mg of bevacizumab as a pre-operative adjunct to PPV in eyes
with TRD secondary to PDR.
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