Preoperative Injection of Bevacizumab Prior to Vitreoretinal Surgery in Diabetic Tractional Retinal Detachment
Condition: Intravitreal Bevacizumab Injection; Pars Plana Vitrectomy; Tractional Retinal Detachment; Diabetic Retinopathy
MeSH terms: Retinal Diseases; Diabetic Retinopathy; Retinal Detachment; Dissociative Disorders
Intervention: Bevacizumab
Intervention description: one intravitreal injection of 2.5 mg Bevacizumab 3-5 days before performing pars plana vitrectomy
Intervention MeSH terms: Bevacizumab
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: Intravitreal Bevacizumab injection; Pars plana vitrectomy; tractional retinal detachment; Diabetic retinopathy

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.
    

Eligibility criteria:

        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.