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NCT Number: NCT00548197

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

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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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Rasool Akram Hospital

Tehran, 14455-364, Iran

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Bevacizumab

Drug

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

Other names: Brand name of Bevacizumab is Avastin

Primary outcomes

  1. Best Corrected Visual Acuity

    Time frame: last follow up, an average of 7 months post-operation

    Post operative best corrected visual acuity ( best distance vision with eyeglasses or contact lenses)

Secondary outcomes

  1. Anatomic Status of the Retina

    Time frame: Last follow up, an average of 7 months post-operation

    Number of Participants with Postoperative Vitreous Hemorrhage

Sponsors and collaborators

Lead sponsor

Iran University of Medical Sciences

Other

Registry information

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Oct 23, 2007
Registry last updated
Oct 16, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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