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Intravitreal bevacizumab for prevention of early postvitrectomy hemorrhage in diabetic patients: a randomized clinical trial.

Author(s): Ahmadieh H, Shoeibi N, Entezari M, Monshizadeh R

Affiliation(s): Ophthalmic Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran. hahmadieh@hotmail.com

Publication date & source: 2009-10, Ophthalmology., 116(10):1943-8. Epub 2009 Aug 21.

Publication type: Randomized Controlled Trial

OBJECTIVE: To evaluate the effect of preoperative intravitreal bevacizumab (IVB) injection on the rate of early (< or =4 weeks) postvitrectomy hemorrhage in patients with proliferative diabetic retinopathy (PDR). DESIGN: Prospective, randomized, double-masked clinical trial. PARTICIPANTS: Sixty-eight eyes of 68 patients undergoing pars plana vitrectomy for management of PDR complications. METHODS: Eligible eyes were assigned randomly to 1 of 2 groups: the IVB group received 1.25 mg intravitreal bevacizumab 1 week before surgery, and the control group underwent a sham procedure. MAIN OUTCOME MEASURES: The primary outcome measure was the incidence of early postvitrectomy hemorrhage. Secondary outcome measures included changes in best-corrected visual acuity (BCVA) and IVB-related adverse events. RESULTS: Of 68 eyes, 35 and 33 eyes were in the IVB and control groups, respectively. In the intention-to-treat analysis, the incidence of postvitrectomy hemorrhage 1 week and 1 month after surgery was significantly lower in the IVB group compared with the control group (P = 0.023 and P = 0.001, respectively). Mean BCVA improved from 1.88 logarithm of minimum angle of resolution (logMAR) units in both study groups before surgery to 0.91 logMAR units and 1.46 logMAR units 1 month after vitrectomy in the IVB and control groups, respectively (P = 0.001). Resolution of vitreous hemorrhage was observed in 9 eyes (25.7%) after IVB injection, obviating the need for vitrectomy; the corresponding figure was 2 eyes (6.1%) in the control group (P = 0.028). The per-protocol analysis included 16 eyes in the IVB group and 18 eyes in the control group; postvitrectomy hemorrhage occurred less frequently 1 week and 1 month after surgery in the IVB group compared with the control group (P = 0.033 and P = 0.003, respectively). Mean improvement in BCVA 1 month after vitrectomy was -1.05 logMAR units in the IVB group and -0.42 logMAR units in the control group (P = 0.004). No IVB-related complication was observed in the treatment group. CONCLUSIONS: Intravitreal injection of bevacizumab 1 week before vitrectomy seems to reduce the incidence of early postvitrectomy hemorrhage in diabetic patients. The need for vitrectomy also may be decreased significantly in these cases.

Page last updated: 2009-10-20

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