Preoperative Injection of Bevacizumab Prior to Vitreoretinal Surgery in Diabetic Tractional Retinal Detachment

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-02-28

Study Completion Date

2008-03-31

Brief Summary

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Vitreoretinal surgery for epiretinal proliferation tractional retinal detachment associated with proliferative diabetic retinopathy (PDR) is often complicated by hemorrhage from fibrovascular tissue. To control the bleeding during tissue dissection multiple measures and techniques are used.

Bevacizumab is an anti VEGF antibody which has been used to induce regression of ocular neovascularization. Its intraocular injection has been increasingly used for treatment of choroidal neovascularization (CNV) associated with age related macular degeneration (AMD) with fairly good success.Also it has been shown to be effective for treatment of PDR complicated with vitreous hemorrhage and iris neovascularization. We hypothesized that if anti-angiogenic agents, such as bevacizumab are injected into the vitreous cavity before vitrectomy in cases of PDR; there may be partial regression of neovascularization resulting in less intraoperative (and postoperative) hemorrhage. This can make the operation easier and shorter and lessen the need for intraocular cautery..

In this study diabetic patients who are candidated for vitrectomy with similar complexity scores will be randomized to preoperative injection or no injection of 2.5 mg Bevacizumab .In the injection group, 2.5 mg of bevacizumab (0.1 ml of commercially available Avastin vial, Genentech, inc. South San Francisco, CA) will be injected into the vitreous 3-5 days before operation.

During each operation, the number of endodiathermy applications, backflush needle applications and the duration of surgery will be recorded by an independent observer. Also, type of tamponade, post operation vitreous hemorrhage and 3 months postoperative visual acuities wil be recorded. all these parameters will be compared in two groups.

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Detailed Description

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Eligibility criteria:

Diabetic tractional retinal detachment-complexity score between 4 and 8

Main outcome measures:

best corrected visual acuity-anatomic condition of the retine(re-attachment of the retina)

Conditions

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Intravitreal Bevacizumab Injection Pars Plana Vitrectomy Tractional Retinal Detachment Diabetic Retinopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Intervention group

Intravitreal Bevacizumab will be injected 2.5 mg IVB 3-5 days before operation in diabetic patients who were candidates for vitrectomy before performing pars plana vitrectomy

Group Type EXPERIMENTAL

Bevacizumab

Intervention Type DRUG

one intravitreal injection of 2.5 mg Bevacizumab 3-5 days before performing pars plana vitrectomy

Control group

no injection before performing pars plana vitrectomy in diabetic patients who were candidates for vitrectomy

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Bevacizumab

one intravitreal injection of 2.5 mg Bevacizumab 3-5 days before performing pars plana vitrectomy

Intervention Type DRUG

Other Intervention Names

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Brand name of Bevacizumab is Avastin

Eligibility Criteria

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Inclusion Criteria

* Those patients with tractional retinal detachment who are candidated for pars plana vitrectomy.
* Complexity score between 4 and 8.

Exclusion Criteria

* Previous vitreoretinal surgery.
* Presence of any other vitreoretinal pathology such as past or present uveitis, and retinal artery or vein occlusion.

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No