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

June 11, 2014 updated by: Ayumu Manabe, Nihon University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

69

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Tokyo, Japan, 101-8309
        • Surugadai Nihon university hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Bevacizumab injection and vitrectomy
0.16 mg/0.05 ml bevacizumab intravitreal injection one day before vitrectomy.
Drug: Bevacizumab
0.16 mg/0.05 ml bevacizumab (single injection on 1 day before operation)
Other Names:
  • Avastin
Procedure: Vitrectomy
vitrectomy of 25 gauge system.
Sham Comparator: Sham injection and vitrectomy
Sham injection one day before vitrectomy.
Procedure: Vitrectomy
vitrectomy of 25 gauge system.
Device: Sham injection
Sham injection one day before vitrectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reoperation
Time Frame: 1 month
Vitreoretinal reoperation due to recurrent vitreous hemorrhage.
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intra Operative Hemorrhage
Time Frame: End of the surgery.
Calculate the number of coagulators for the intra operative hemorrhage.
End of the surgery.
Postoperative Vitreous Hemorrhage.
Time Frame: 1 month
Postoperative vitreous hemorrhage that is permitted within 4 weeks after surgery.
1 month
Vascular Endothelial Growth Factor Concentration in Vitreous
Time Frame: Start of surgery.
Vascular endothelial growth factor concentration in vitreous at the start of vitrectomy.
Start of surgery.
Endolaser Photocoagulation
Time Frame: End of surgery.
Number of intraoperative endolaser photocoagulation.
End of surgery.
Iatrogenic Retinal Tears
Time Frame: End of surgery.
The number of participants who had intraoperative iatrogenic retinal tears.
End of surgery.
Surgical Time
Time Frame: End of surgery.
End of surgery.
Postoperative Best Corrected Visual Acuity
Time Frame: 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.
1 mouth after surgery.
Best Corrected Visual Acuity Change
Time Frame: 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.
1 month
Postoperative Neovascular Glaucoma
Time Frame: Within 1 month after the surgery.
The number of participants with progressive or persistent neovascular glaucoma after surgery.
Within 1 month after the surgery.
Elevated Intraocular Pressure
Time Frame: Within 1 month after the surgery.
The number of participants with elevated intraocular pressure after surgery.
Within 1 month after the surgery.
Gas Tamponade
Time Frame: End of surgery.
The number of participants with gas tamponade at the end of the surgery.
End of surgery.
Silicon Oil Tamponade
Time Frame: End of surgery.
The number of participants with silicon oil tamponade at the end of the surgery.
End of surgery.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nihon University

Investigators

  • Study Chair: Ayumu Manabe

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (Actual)

August 1, 2013

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

May 13, 2013

First Submitted That Met QC Criteria

May 13, 2013

First Posted (Estimate)

May 15, 2013

Study Record Updates

Last Update Posted (Estimate)

July 14, 2014

Last Update Submitted That Met QC Criteria

June 11, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCT-NAPN-23170

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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