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

Sponsor
Nihon University
Study ID
NCT01854593
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Bevacizumab — DRUG
    0.16 mg/0.05 ml bevacizumab (single injection on 1 day before operation)
  • Vitrectomy — PROCEDURE
    vitrectomy of 25 gauge system.
  • Sham injection — DEVICE
    Sham injection one day before vitrectomy

Study Details

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.

Key Dates

First listed
May 15, 2013
Start date
May 31, 2012
Status verified
Jun 2014
Primary completion
Aug 31, 2013
Completion
Mar 31, 2014

Study Design

Enrollment
69 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Bevacizumab injection and vitrectomy
    0.16 mg/0.05 ml bevacizumab intravitreal injection one day before vitrectomy.
  • Sham Comparator: Sham injection and vitrectomy
    Sham injection one day before vitrectomy.

Primary Outcome Measure

Reoperation [ Time Frame: 1 month ]