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

NCT01854593 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 69

Last updated 2014-07-14

Study results available
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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.

Conditions

  • Proliferative Diabetic Retinopathy
  • Diabetic Traction Retinal Detachment
  • Vitreous Hemorrhage

Interventions

DRUG

Bevacizumab

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

PROCEDURE

Vitrectomy

vitrectomy of 25 gauge system.

DEVICE

Sham injection

Sham injection one day before vitrectomy

Sponsors & Collaborators

  • Nihon University

    lead OTHER

Principal Investigators

  • Ayumu Manabe

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2013-08-31
Completion
2014-03-31

Countries

  • Japan

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01854593 on ClinicalTrials.gov