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Efficacy of PreOperative Bevacizumab for Diabetic Eye Disease

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01041690
First Posted: January 1, 2010
Last Update Posted: January 1, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Cairo University
  Purpose
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.

Condition Intervention
Proliferative Diabetic Retinopathy Drug: Bevacizumab

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Bevacizumab (Avastin) as an Adjunct to Vitrectomy in the Management of Severe Proliferative Diabetic Retinopathy: a Prospective Case Series

Resource links provided by NLM:


Further study details as provided by Cairo University:

Primary Outcome Measures:
  • Intra- and post-operative bleedings were recorded. [ Time Frame: 3 months ]

Secondary Outcome Measures:
  • Best Corrected Visual Acuity [ Time Frame: 3 months ]

Enrollment: 19
Study Start Date: June 2007
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bevacizumab Drug: Bevacizumab
Other Name: Avastin

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   9 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01041690


Locations
Egypt
Department Of Ophthalmology
Cairo, Egypt, 11221
Sponsors and Collaborators
Cairo University
  More Information

Responsible Party: Tamer Ahmed Macky, Cairo University
ClinicalTrials.gov Identifier: NCT01041690     History of Changes
Other Study ID Numbers: Beva-Cairo-A1
First Submitted: December 31, 2009
First Posted: January 1, 2010
Last Update Posted: January 1, 2010
Last Verified: January 2007

Keywords provided by Cairo University:
Proliferative Diabetic Retinopathy
Vitrectomy
Bevacizumab

Additional relevant MeSH terms:
Retinal Diseases
Diabetic Retinopathy
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents