Efficacy of PreOperative Bevacizumab for Diabetic Eye Disease

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01041690
• Other study ID #: Beva-Cairo-A1
• Status: Completed
• Phase: N/A
• First received: December 31, 2009
• Last updated: December 31, 2009
• Start date: June 2007
• Est. completion date: June 2008

Study information

• Verified date: January 2007
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 9 Years to 40 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Retinopathy
• Proliferative Diabetic Retinopathy
• Retinal Diseases

Intervention

Drug:
• Bevacizumab

Locations

Country	Name	City	State
Egypt	Department Of Ophthalmology	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intra- and post-operative bleedings were recorded.		3 months	No
Secondary	Best Corrected Visual Acuity		3 months	No