Proliferative Diabetic Retinopathy Clinical Trial
Official title:
Prospective Randomized Controlled Study of Intravitreal Injection of 0.16 mg Bevacizumab One Day Before Surgery for Proliferative Diabetic Retinopathy
We hypothesized that to reduce the adverse effects of intravitreal bevacizumab on ocular tissue and whole body, intravitreal injection of a low concentration of bevacizumab and conducting vitrectomy shortly after the injection is useful. In the present prospective, double-masked, randomized, controlled study, we aimed to verify the usefulness of intravitreal injection of 0.16 mg/0.05 ml bevacizumab one day before conducting vitrectomy for PDR.
Early postoperative hemorrhage in proliferative diabetic retinopathy (PDR) patients is a
major complication. Intravitreal injection of anti-vascular endothelial growth factor (VEGF)
has reported to reduce vitreous hemorrhage. Recently, numerous reports have shown the
efficacy of reducing neovascularization activity before vitrectomy by preoperative
intravitreal injection of anti-VEGF agents. When intravitreal bevacizumab (IVB) injection is
used as an adjunct therapy, a shortterm effect is needed. Because it is reported some
adverse events caused by bevacizumab injection. Hattori et al reported intravitreal
injection of 0.16 mg/0.05 ml bevacizumab in PDR patients marked blockage of intravitreal
VEGF concentrations in the pilot study. The purpose of this study is to evaluate low dose of
intravitreal bevacizumab as a preoperative adjunct therapy reduce the postoperative vitreous
hemorrhage. This study involves PDR patients who underwent vitrectomy between May 2012 and
August 2013 at Surugadai Hospital of Nihon University. The risks to participants are
accompanied by the intravitreal injection of bevacizumab (especially the possibility of
endophthalmitis and thromboembolic events).
Between June 2012 and August 2013, one investigator (AM) randomized PDR patients with an
indication for primary 25-gauge vitrectomy into a sham group and an IVB group. One day after
injection, three surgeons except AM conducted the surgeries. Vitreous samples were collected
at the start of surgery, and intraoperative and postoperative complications were evaluated.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment
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