Adjuvant Intravitreal Bevacizumab in Pars Plana Vitrectomy for Vitreous Hemorrhage

Conditions

• Vitreous Hemorrhage Secondary to PDR

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Bevacizumab — DRUG
  1.25 mg of bevacizumab (0.05 ml) 7 days before vitrectomy
• bevacizumab — DRUG
  1.25 mg of bevacizumab (0.05 ml) at the end of vitrectomy

Study Details

The purpose of this study is to determine the effect of pre and intra-operative bevacizumab injection on postoperative vitreous hemorrhage after diabetic vitrectomy in comparison to vitrectomy without bevacizumab injection.

Key Dates

First listed

Mar 24, 2010

Start date

Jan 31, 2010

Status verified

Mar 2010

Primary completion

Sep 30, 2010

Completion

Mar 31, 2011

Study Design

Enrollment

1 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Arms

• No Intervention: 1 - no bevacizumab
  Patients will not receive bevacizumab before nor during vitrectomy
• Experimental: 2- bevacizumab before vitrectomy
  Patients will receive intravitreal injection of 1.25 mg of bevacizumab (0.05 ml) 7 days before vitrectomy
• Experimental: 3- bevacizumab after vitrectomy
  Patients will receive intravitreal injection of 1.25 mg of bevacizumab (0.05 ml) at the end of vitrectomy

Primary Outcome Measure

Recurrent vitreous hemorrhage incidence after vitrectomy [ Time Frame: 3 months ]

Central Contacts

• Hospital das Clínicas de Ribeirão Preto - USP