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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00548197
Recruitment Status : Unknown
Verified October 2007 by Iran University of Medical Sciences.
Recruitment status was:  Recruiting
First Posted : October 23, 2007
Last Update Posted : October 23, 2007
Information provided by:
Iran University of Medical Sciences

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Intravitreal Bevacizumab Injection Pars Plana Vitrectomy Tractional Retinal Detachment Diabetic Retinopathy Drug: Bevacizumab Phase 1

Detailed Description:

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)

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Preoperative Injection of Bevacizumab Prior to Vitreoretinal Surgery in Diabetic Tractional Retinal Detachment
Study Start Date : February 2007
Estimated Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Bevacizumab

Arm Intervention/treatment
Experimental: A
Intravitreal Bevacizumab will be injected in this group before performing pars plana vitrectomy
Drug: Bevacizumab
one intravitreal injection of 2.5 mg Bevacizumab 3-5 days before performing pars plana vitrectomy
Other Name: Brand name of Bevacizumab is Avastin

Primary Outcome Measures :
  1. Best corrected visual acuity [ Time Frame: last follow up ]

Secondary Outcome Measures :
  1. Anatomic status of the retina [ Time Frame: Last follow up ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00548197

Contact: Mehdi Modarres, MD 00989121266221

Iran, Islamic Republic of
Rasool Akram Hospital Recruiting
Tehran, Iran, Islamic Republic of, 14455-364
Sponsors and Collaborators
Iran University of Medical Sciences
Study Director: Mehdi Modarres, MD Iran University of Medical Sciences(IUMS)

Publications: Identifier: NCT00548197     History of Changes
Other Study ID Numbers: 85-A-57
First Posted: October 23, 2007    Key Record Dates
Last Update Posted: October 23, 2007
Last Verified: October 2007

Keywords provided by Iran University of Medical Sciences:
Intravitreal Bevacizumab injection
Pars plana vitrectomy
tractional retinal detachment
Diabetic retinopathy

Additional relevant MeSH terms:
Retinal Diseases
Diabetic Retinopathy
Dissociative Disorders
Retinal Detachment
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Mental Disorders
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents