Efficacy of PreOperative Bevacizumab for Diabetic Eye Disease

Cairo University (CU)

Status: Completed

Conditions: Proliferative Diabetic Retinopathy

Treatments: Drug: Bevacizumab

Study type: Interventional

Funder types: Other

Identifiers

NCT01041690

Beva-Cairo-A1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 19 patients

Sex: All

Ages: 9 to 40 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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19 participants in 1 patient group

Bevacizumab

Experimental group

Treatment:

Drug: Bevacizumab