Prospective Randomized Controlled Study of Intravitreal Injection of Bevacizumab for Proliferative Diabetic Retinopathy

Phase 4

Completed

Conditions: Vitreous Hemorrhage
Proliferative Diabetic Retinopathy
Diabetic Traction Retinal Detachment

Interventions: Drug: Bevacizumab
Procedure: Vitrectomy
Device: Sham injection

Registration Number: NCT01854593

Lead Sponsor: Nihon University

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 69

Inclusion Criteria

Clinical diagnosis of Proliferative Diabetic Retinopathy (PDR)
Indicated for vitrectomy

Exclusion Criteria

History of intraocular surgery, intravitreal injection of drugs or sub-Tenon injection of steroids or retinal photocoagulation within 6 months

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bevacizumab injection and vitrectomy	Vitrectomy	0.16 mg/0.05 ml bevacizumab intravitreal injection one day before vitrectomy.
Sham injection and vitrectomy	Vitrectomy	Sham injection one day before vitrectomy.
Sham injection and vitrectomy	Sham injection	Sham injection one day before vitrectomy.
Bevacizumab injection and vitrectomy	Bevacizumab	0.16 mg/0.05 ml bevacizumab intravitreal injection one day before vitrectomy.

Primary Outcome Measures

Name	Time	Method
Reoperation	1 month	Vitreoretinal reoperation due to recurrent vitreous hemorrhage.

Secondary Outcome Measures

Name	Time	Method
Surgical Time	End of surgery.
Intra Operative Hemorrhage	End of the surgery.	Calculate the number of coagulators for the intra operative hemorrhage.
Postoperative Vitreous Hemorrhage.	1 month	Postoperative vitreous hemorrhage that is permitted within 4 weeks after surgery.
Vascular Endothelial Growth Factor Concentration in Vitreous	Start of surgery.	Vascular endothelial growth factor concentration in vitreous at the start of vitrectomy.
Endolaser Photocoagulation	End of surgery.	Number of intraoperative endolaser photocoagulation.
Postoperative Best Corrected Visual Acuity	1 mouth after surgery.	Best corrected visual acuity was measured using the Landolt ring chart, and the result was converted to logMAR notation for analysis. The minimum of the scale is 2.0 and the maximum of the scale is -0.3. The higher values represent a worse outcome.
Best Corrected Visual Acuity Change	1 month	Best corrected visual acuity change was calculated by postoperative logMAR visual acuity minus preoperative logMAR visual acuity. The higher values represent a worse outcome.
Gas Tamponade	End of surgery.	The number of participants with gas tamponade at the end of the surgery.
Iatrogenic Retinal Tears	End of surgery.	The number of participants who had intraoperative iatrogenic retinal tears.
Postoperative Neovascular Glaucoma	Within 1 month after the surgery.	The number of participants with progressive or persistent neovascular glaucoma after surgery.
Elevated Intraocular Pressure	Within 1 month after the surgery.	The number of participants with elevated intraocular pressure after surgery.
Silicon Oil Tamponade	End of surgery.	The number of participants with silicon oil tamponade at the end of the surgery.