Efficacy of PreOperative Bevacizumab for Diabetic Eye Disease

NCT ID: NCT01041690

Last Updated: 2010-01-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-06-30
• Study Completion Date: 2008-06-30

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.

Conditions

Proliferative Diabetic Retinopathy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Bevacizumab

Group Type: EXPERIMENTAL

Bevacizumab

Intervention Type: DRUG

Interventions

Bevacizumab

Intervention Type: DRUG

Other Intervention Names

Avastin

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)

• Minimum Eligible Age: 9 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Cairo University

Locations

Department Of Ophthalmology

Cairo, Cairo Governorate, Egypt

Countries

Egypt

Other Identifiers

Beva-Cairo-A1

Identifier Type: -

Identifier Source: org_study_id