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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
224
A sterile lid speculum is used to separate the lids. A subconjunctival injection of 1% lidocaine is applied to the inferotemporal quadrant. A 5% povidone iodine solution is used to disinfect the entire conjunctival surface. 1.25 mg / 0.05 mL of bevacizumab is injected using a 30-gauge needle inserted through the inferotemporal pars plana 3.5 mm from the limbus.
King Khaled Eye Specialist Hospital
Riyadh, Saudi Arabia
Intraoperative bleeding
Time frame: 12 months
Total surgical time
Time frame: 12 months
Post-operative vitreous hemorrhage
Early (\<1 month) and late (≥ 1 month) post-operative vitreous hemorrhage (VH) (Yes or No)
Time frame: 12 months
Visual acuity change
Mean change in best-corrected visual acuity (BCVA) at 12 months
Time frame: 12 months
Number of endodiathermy applications
Time frame: 12 months
Intraoperative breaks
Time frame: 12 months
Change in central macular thickness
Time frame: 12 months
Proportion of eyes gaining at least 15 letters of BCVA
Time frame: 12 months
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