Results from the PACORES group clinical trial debunked previously-held beliefs that IVB is unsafe for patients with proliferative diabetic retinopathy undergoing the procedure.
J. Fernando Arevalo, MD
Intravitreal bevacizumab (IVB) injection may serve as a beneficial pre-operative adjuvant therapy for certain patients undergoing pars plana virectomy (PPV), according to a new study.
In the results of the randomized, controlled PACORES group clinical trial—presented at the American Society of Retina Specialists (ASRS) Annual Meeting in Vancouver, BC on Tuesday— researchers reported 1.25 mg IVB serves as a beneficial therapy to patients with tractional retinal detachment (TRD) secondary proliferative diabetic retinopathy (PDR) who are undergoing small-gauge PPV.
The findings are particularly interesting to author J. Fernando Arevalo, MD, who told MD Magazine® there’s been “a lot of controversy in the retina community” surrounding the use of IVB prior to PPV.
“Some studies have shown it’s useful, it decreases bleeding during, it makes surgery somewhat easier,” Arevalo said. “But at the same time, some studies have reported IVB can cause TRD in patients with PDR, and also cause progression in TRD.”
The prospective, double-masked, active-controlled trial randomized 211 patients 3:1 to either PPV plus IVB (n= 158) or PPV plus sham (n= 53). All treated eyes (n= 211) underwent a baseline exam to establish best corrected visual acuity (BCVA), color photos, optical coherence tomography (OCT), and fluorescein angiography (FA).
Patients were observed for 12 months, and researchers observed for outcome measures in improved surgical field visualization, reduced operative time, and intra-operative complications.
Researchers reported intraoperative iaotrogenic renital breaks in 63 patients (39.8%) of the IVB group, and 38 patients (56.6%) in the control group (P = 0.003). The IVB group tallied 50 patients (31.6%) with grade 2 intraoperative bleeding, while the control group had 38 patients (53%; P = 0.001). All patients with intraoperative bleeding required endodiathermy.
Mean operative time was 19% quicker for the adjuvant-treated patients—55 minutes in the IVB group and 68 minutes in the control group (P = 0.072).
Early postoperative vitreous hemorrhage was reported in 51 IVB patients (32.2%) and 38 control patients (71.6%; P = 0.001).
BCVA scores improved from logMAR 2 ± 0.5 to logMAR 0.7 ± 0.48 in the IVB patients, and improved from logMAR 1.9 ± 0.5 to logMAR 0.9 ± 0.31 in the control group (P = 0.068).
Researchers noted no significant difference between patient groups in retinal reattachment. However, pre-operative IVB was proven to improve on rates of intraoperative bleeding, surgical visual field visualization, and both intraoperative and postoperative complications.
The comparative study results indicate that surgeons faced a “less complicated” procedure when operating on patients administered IVB, Arevalo said. It’s similarly crucial findings for patients with PDR who may not respond to initial anti-vascular endothelial growth factor (anti-VEGF) therapy and are facing the probability of PPV procedure.
“Even if we don’t do surgery but can reach patients in stage where retinal proliferation can be useful, the adjunctive intravitreal bevacizumab can be helpful,” Arevalo said.
The study, "Preoperative Intravitreal Bevacizumab for TRD Secondary to PDR: A Prospective Randomized Clinical Trial of the PACORES Group," was presented at ASRS 2018 on Tuesday.
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