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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2007 by Iran University of Medical Sciences.
Recruitment status was:  Recruiting
Information provided by:
Iran University of Medical Sciences Identifier:
First received: October 22, 2007
Last updated: NA
Last verified: October 2007
History: No changes posted

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 Intervention Phase
Intravitreal Bevacizumab Injection Pars Plana Vitrectomy Tractional Retinal Detachment Diabetic Retinopathy Drug: Bevacizumab Phase 1

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Iran University of Medical Sciences:

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

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

Estimated Enrollment: 50
Study Start Date: February 2007
Estimated Study Completion Date: December 2007
Arms Assigned Interventions
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

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)


Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
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.
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Please refer to this study by its identifier: 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)
  More Information

Publications: Identifier: NCT00548197     History of Changes
Other Study ID Numbers: 85-A-57
Study First Received: October 22, 2007
Last Updated: October 22, 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 processed this record on September 21, 2017