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Clinical Trials/NCT01041690
NCT01041690
Completed
Not Applicable

Bevacizumab (Avastin) as an Adjunct to Vitrectomy in the Management of Severe Proliferative Diabetic Retinopathy: a Prospective Case Series

Cairo University1 site in 1 country19 target enrollmentJune 2007

Overview

Phase
Not Applicable
Intervention
Bevacizumab
Conditions
Proliferative Diabetic Retinopathy
Sponsor
Cairo University
Enrollment
19
Locations
1
Primary Endpoint
Intra- and post-operative bleedings were recorded.
Status
Completed
Last Updated
16 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
June 2007
End Date
June 2008
Last Updated
16 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • Tractional Retinal Detachment involving or threatening the macula,
  • Tractional+Rhegmatogenous Retinal Detachment, or
  • Fibrovascular tissue covering and distorting the macula.

Exclusion Criteria

  • Vitrectomy
  • Neovascular glaucoma
  • Dense media opacity (dense cataract and vitreous hemorrhage) precluding fluorescein angiography (FA)

Arms & Interventions

Bevacizumab

Intervention: Bevacizumab

Outcomes

Primary Outcomes

Intra- and post-operative bleedings were recorded.

Time Frame: 3 months

Secondary Outcomes

  • Best Corrected Visual Acuity(3 months)

Study Sites (1)

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