Proliferative Diabetic Retinopathy Clinical Trial
Official title:
Bevacizumab (Avastin) as an Adjunct to Vitrectomy in the Management of Severe Proliferative Diabetic Retinopathy: a Prospective Case Series
Reports of the use of intravitreal bevacizumab (Avastin, Genentech) for the reduction of neovascularization in proliferative diabetic retinopathy have demonstrated significant regression in the number of new vessels. Reducing the vascularity of neovascular fibrovascular tissue can potentially reduce bleeding intraoperatively and thus facilitate the vitrectomy procedure. The investigators chose to investigate the potential benefit of the use of preoperative bevacizumab in the management of these most complex cases.
PURPOSE: To evaluate the role of preoperative intravitreal bevacizumab as an adjunct to
vitrectomy in the management of severe diabetic eye disease.
SETTINGS: Kasr El-Aini Teaching Hospital - Cairo University from 2007 to 2008. METHODS:
Twenty eyes of 19 patients with severe proliferative diabetic retinopathy were recruited
into the study. All eyes underwent a single intravitreal injection of bevacizumab 1.25 mg in
0.05 ml one week prior to vitrectomy for tractional (14), combined tractional/rhegmatogenous
retinal detachment (4), and fibrovascular tissue covering/distorting the macula (2).
Exclusion criteria were: previous vitrectomy, neovascular glaucoma, and dense media opacity
(dense cataract and vitreous hemorrhage) precluding fluorescein angiography (FA) that was
done pre- and 1 week post injections. Best corrected visual acuity (BCVA), anterior segment
with dilated fundus examinations, and intraocular pressures (IOP), were done pre-, 1 week
post-injections, 1 day, 1 week and monthly for 3 months post-vitrectomy. Intra- and
post-operative bleedings were recorded.
;
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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