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Efficacy of PreOperative Bevacizumab for Diabetic Eye Disease

This study has been completed.
Sponsor:
Information provided by:
Cairo University
ClinicalTrials.gov Identifier:
NCT01041690
First received: December 31, 2009
Last updated: NA
Last verified: January 2007
History: No changes posted

December 31, 2009
December 31, 2009
June 2007
June 2008   (final data collection date for primary outcome measure)
Intra- and post-operative bleedings were recorded. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
Best Corrected Visual Acuity [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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

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.

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.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Proliferative Diabetic Retinopathy
Drug: Bevacizumab
Other Name: Avastin
Experimental: Bevacizumab
Intervention: Drug: Bevacizumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
19
June 2008
June 2008   (final data collection date for primary outcome measure)

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)
Both
9 Years to 40 Years
No
Contact information is only displayed when the study is recruiting subjects
Egypt
 
NCT01041690
Beva-Cairo-A1
Yes
Tamer Ahmed Macky, Cairo University
Cairo University
Not Provided
Not Provided
Cairo University
January 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP