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Efficacy of PreOperative Bevacizumab for Diabetic Eye Disease

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01041690
Enrollment
19
Registered
2010-01-01
Start date
2007-06-30
Completion date
2008-06-30
Last updated
2010-01-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Proliferative Diabetic Retinopathy

Keywords

Proliferative Diabetic Retinopathy, Vitrectomy, Bevacizumab

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.

Interventions

DRUGBevacizumab

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
9 Years to 40 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frame
Intra- and post-operative bleedings were recorded.3 months

Secondary

MeasureTime frame
Best Corrected Visual Acuity3 months

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026