Pars Plana Vitrectomy (PPV) Versus Preoperative Intravitreal Bevacizumab Plus PPV to Treat Diabetic Tractional Retinal Detachment (IBETRA)

Sponsor
University of Sao Paulo
Study ID
NCT00690768
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Bevacizumab — DRUG
    Intravitreal bevacizumab (1.5 mg; 0,06 ml) 1 week after baseline; pars plana vitrectomy 3 weeks after baseline
  • pars plana vitrectomy — PROCEDURE
    pars plana vitrectomy 3 weeks after baseline

Study Details

The purpose of this study is to compare the amount of intraoperative intraocular bleeding during 23-gauge pars plana vitrectomy (PPV) for diabetic traction retinal detachment (TRD) with and without preoperative intravitreal bevacizumab treatment.

Key Dates

First listed
Jun 5, 2008
Start date
Mar 31, 2008
Status verified
May 2008
Primary completion
May 31, 2008
Completion
May 31, 2008

Study Design

Enrollment
20 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

amount of intraoperative intra-ocular bleeding [ Time Frame: three weeks ]

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