Efficacy of PreOperative Bevacizumab for Diabetic Eye Disease

Not Applicable

Completed

• Conditions: Proliferative Diabetic Retinopathy
• Interventions: Drug: Bevacizumab

• Registration Number: NCT01041690
• Lead Sponsor: Cairo University

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.

Study Timeline

• Status Verified: 2007-01
• Study Start: 2007-06
• Primary Completion: 2008-06
• Study Completion: 2008-06
• Study First Submitted: 2009-12-31
• Study First Submitted QC: 2009-12-31
• Last Update Submitted: 2009-12-31
• Study First Posted: 2010-01-01
• Last Update Posted: 2010-01-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Bevacizumab	Bevacizumab	-

Primary Outcome Measures

Name	Time	Method
Intra- and post-operative bleedings were recorded.	3 months

Secondary Outcome Measures

Name	Time	Method
Best Corrected Visual Acuity	3 months

Trial Locations

Locations (1)

Department Of Ophthalmology; 🇪🇬 Cairo, Egypt