CClinicalTrials.gg
Status unknownNCT01151722ABeViUpdated Jun 28, 2010

Adjuvant Intravitreal Bevacizumab in Pars Plana Vitrectomy for Diabetic Vitreous Hemorrhage

A Phase 2 interventional study of bevacizumab injection and bevacizumab injection in Recurrent and Hemorrhage, sponsored by University of Sao Paulo. Status unknown at 1 site in Brazil. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2010-06-28.

Sponsored by University of Sao Paulo · Phase 2, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Feb 2010), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
2
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

Postoperative vitreous hemorrhage is a common complication after vitrectomy for proliferative diabetic retinopathy. There have been efforts to lower the incidence of postoperative vitreous hemorrhage such as preoperative bevacizumab injection. Bevacizumab (Avastin) is a potent inhibitor of angiogenesis and has been shown to decrease retinal and iris neovascularization in proliferative diabetic retinopathy. Recently there have been reports showing that preoperative bevacizumab injection could reduce intraoperative bleeding from abnormal vessels and could make surgery easier and more successful. Our hypothesis is that intraoperative bevacizumab injection could reduce postoperative vitreous hemorrhage by inhibiting the vessel formation after surgery.

We started the prospective randomized comparative study to determine the effect of pre and intra-operative bevacizumab injection on postoperative vitreous hemorrhage after diabetic vitrectomy in comparison to vitrectomy without any adjuvant drug.

02

Conditions studied

  • Recurrent
  • Hemorrhage
03

In context

Vitreous Hemorrhage

41 studies on the registry are indexed under Vitreous Hemorrhage; 3 are open to participants now.

This study's planned enrollment of 2 is below the median of 61 across 33 interventional studies indexed under Vitreous Hemorrhage.

Browse Vitreous Hemorrhage studies →

Lead sponsor

University of Sao Paulo is the lead sponsor of 1,005 studies on the registry; 90 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • patients undergoing first vitrectomy for vitreous hemorrhage secondary to proliferative diabetic retinopathy

Exclusion criteria

Exclusion Criteria:

  • follow-up period of less than 3 months
  • not first vitrectomy
  • abnormal blood coagulation
  • uncontrolled hypertension
05

Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
2 participants (estimated)

Study arms

  • No intervention
    no injection

    no bevacizumab

  • Experimental
    experimental 2

    bevacizumab before vitrectomy

    Procedure: bevacizumab injection

  • Experimental
    experimental 3

    bevacizumab after vitrectomy

    Procedure: bevacizumab injection

Interventions

  • Procedurebevacizumab injection

    bevacizumab injection before vitrectomy

  • Procedurebevacizumab injection

    bevacizumab injection after vitrectomy

06

What researchers measure

Primary outcomes

  1. Vitreous hemorrhage recurrence

    Time frame: 3 months

07

Study locations

1 of 1 sites recruiting
  • Hospital das Clínicas de Ribeirão Preto - University of São Paulo
    Ribeirão Preto, Sao Paulo 14049-990, Brazil
    • Felipe Almeida, MD · Contact · felipeppalmeida@yahoo.com.br · 16 3602-2523
    • Felipe Almeida · Contact
    • Felipe Almeida, MD · Principal investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 28, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01151722
Lead sponsor
University of Sao Paulo
First posted
Jun 28, 2010
Start date
Dec 2009
Primary completion
Dec 2010 (estimated)
Last update
Jun 28, 2010

Study contacts

Felipe Almeida
Contact
felipeppalmeida@yahoo.com.br

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2010. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion