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

NCT ID: NCT01854593

Last Updated: 2014-07-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 69 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-05-31
• Study Completion Date: 2014-03-31

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.

Conditions

Proliferative Diabetic Retinopathy; Diabetic Traction Retinal Detachment; Vitreous Hemorrhage

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Bevacizumab injection and vitrectomy

0.16 mg/0.05 ml bevacizumab intravitreal injection one day before vitrectomy.

Group Type: ACTIVE_COMPARATOR

Bevacizumab

Intervention Type: DRUG

0.16 mg/0.05 ml bevacizumab (single injection on 1 day before operation)

Vitrectomy

Intervention Type: PROCEDURE

vitrectomy of 25 gauge system.

Sham injection and vitrectomy

Sham injection one day before vitrectomy.

Group Type: SHAM_COMPARATOR

Vitrectomy

Intervention Type: PROCEDURE

vitrectomy of 25 gauge system.

Sham injection

Intervention Type: DEVICE

Sham injection one day before vitrectomy

Interventions

Bevacizumab

0.16 mg/0.05 ml bevacizumab (single injection on 1 day before operation)

Intervention Type: DRUG

Vitrectomy

vitrectomy of 25 gauge system.

Intervention Type: PROCEDURE

Sham injection

Sham injection one day before vitrectomy

Intervention Type: DEVICE

Other Intervention Names

Avastin

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nihon University

OTHER

Sponsor Role: lead

Responsible Party

Ayumu Manabe

Ayumu Manabe

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ayumu Manabe

Role: STUDY_CHAIR

Locations

Surugadai Nihon University Hospital

Tokyo, , Japan

Countries

Japan

Other Identifiers

CCT-NAPN-23170

Identifier Type: -

Identifier Source: org_study_id