Diabetic Retinopathy Clinical Trial
Official title:
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.
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)
;
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