Intravitreal Bevacizumab for Surgical Treatment of Severe Proliferative Diabetic Retinopathy

This study has been completed.

Sponsor:

Collaborator:

Napoli CTO Hospital

Information provided by:

Second University of Naples

ClinicalTrials.gov Identifier:

NCT01025934

First received: December 3, 2009

Last updated: NA

Last verified: December 2009

History: No changes posted

Tracking Information
First Received Date ^ICMJE	December 3, 2009
Last Updated Date	December 3, 2009
Start Date ^ICMJE	Not Provided
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	No Changes Posted
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Intravitreal Bevacizumab for Surgical Treatment of Severe Proliferative Diabetic Retinopathy
Official Title ^ICMJE	Intravitreal Bevacizumab for Surgical Treatment of Severe Proliferative Diabetic Retinopathy
Brief Summary	The purpose of this study is to evaluate the role, the safety and the effectiveness of Intravitreal Bevacizumab injections as an adjunct to vitrectomy in the management of severe proliferative diabetic retinopathy.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 4
Study Design ^ICMJE	Primary Purpose: Treatment
Condition ^ICMJE	Proliferative Diabetic Retinopathy
Intervention ^ICMJE	Drug: Bevacizumab Other: sham
Study Arm (s)	Active Comparator: 7 days Intervention: Drug: Bevacizumab Active Comparator: 20 days Intervention: Drug: Bevacizumab Sham Comparator: sham Intervention: Other: sham
Publications *	di Lauro R, De Ruggiero P, di Lauro R, di Lauro MT, Romano MR. Intravitreal bevacizumab for surgical treatment of severe proliferative diabetic retinopathy. Graefes Arch Clin Exp Ophthalmol. 2010 Jun;248(6):785-91. Epub 2010 Feb 5.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	Not Provided
Completion Date	Not Provided
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	Inclusion Criteria: vitreous haemorrhage tractional retinal detachment active proliferative diabetic retinopathy. Exclusion Criteria: neovascular glaucoma cataract combined traction and rhegmatogenous RD
Gender	Both
Ages	Not Provided
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT01025934
Other Study ID Numbers ^ICMJE	IVBDRNA
Has Data Monitoring Committee	No
Responsible Party	Not Provided
Study Sponsor ^ICMJE	Second University of Naples
Collaborators ^ICMJE	Napoli CTO Hospital
Investigators ^ICMJE	Not Provided
Information Provided By	Second University of Naples
Verification Date	December 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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