Preoperative Bevacizumab for Vitreous Hemorrhage

Sponsor
University of Sao Paulo
Study ID
NCT00596297
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • bevacizumab — DRUG
    Intravitreal bevacizumab (1.5 mg; 0,06 ml) 1 day after baseline; pars plana vitrectomy 4 weeks after baseline
  • pars plana vitrectomy — PROCEDURE
    4 weeks after baseline

Study Details

The purpose of this study is to determine whether preoperative intravitreal bevacizumab is effective in reducing intra-operative and postoperative bleeding in diabetic patients submitted to pars plana vitrectomy for vitreous hemorrhage.

Key Dates

First listed
Jan 16, 2008
Start date
Nov 30, 2007
Status verified
Sep 2008
Primary completion
Sep 30, 2008
Completion
Sep 30, 2008

Study Design

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

Arms

  • Experimental: A
    Preoperative Intravitreal bevacizumab and pars plana vitrectomy
  • Active Comparator: B
    Pars plana vitrectomy only

Primary Outcome Measure

Intra- and postoperative intra-ocular bleeding [ Time Frame: 12 weeks ]

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