Adjuvant Intravitreal Bevacizumab in Pars Plana Vitrectomy for Diabetic Vitreous Hemorrhage

NCT ID: NCT01151722

Last Updated: 2010-06-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Recurrent Hemorrhage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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no injection

no bevacizumab

Group Type NO_INTERVENTION

No interventions assigned to this group

experimental 2

bevacizumab before vitrectomy

Group Type EXPERIMENTAL

bevacizumab injection

Intervention Type PROCEDURE

bevacizumab injection before vitrectomy

experimental 3

bevacizumab after vitrectomy

Group Type EXPERIMENTAL

bevacizumab injection

Intervention Type PROCEDURE

bevacizumab injection after vitrectomy

Interventions

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bevacizumab injection

bevacizumab injection before vitrectomy

Intervention Type PROCEDURE

bevacizumab injection

bevacizumab injection after vitrectomy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* follow-up period of less than 3 months
* not first vitrectomy
* abnormal blood coagulation
* uncontrolled hypertension
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

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USP

Locations

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Hospital das Clínicas de Ribeirão Preto - University of São Paulo

Ribeirão Preto, São Paulo, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Felipe Almeida

Role: CONTACT

Facility Contacts

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Felipe Almeida, MD

Role: primary

16 3602-2523 ext. 2523

Felipe Almeida

Role: backup

References

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Dervenis P, Dervenis N, Smith JM, Steel DH. Anti-vascular endothelial growth factors in combination with vitrectomy for complications of proliferative diabetic retinopathy. Cochrane Database Syst Rev. 2023 May 31;5(5):CD008214. doi: 10.1002/14651858.CD008214.pub4.

Reference Type DERIVED
PMID: 37260074 (View on PubMed)

Other Identifiers

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HCRP22

Identifier Type: -

Identifier Source: org_study_id

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