Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Intravitreal Bevacizumab for Surgical Treatment of Severe Proliferative Diabetic Retinopathy

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.
 
ClinicalTrials.gov Identifier: NCT01025934
Recruitment Status : Completed
First Posted : December 4, 2009
Last Update Posted : December 4, 2009
Sponsor:
Collaborator:
Napoli CTO Hospital
Information provided by:
University of Campania "Luigi Vanvitelli"

Tracking Information
First Submitted Date  ICMJE December 3, 2009
First Posted Date  ICMJE December 4, 2009
Last Update Posted Date December 4, 2009
Study 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 Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures 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  ICMJE Phase 4
Study Design  ICMJE Primary Purpose: Treatment
Condition  ICMJE Proliferative Diabetic Retinopathy
Intervention  ICMJE
  • Drug: Bevacizumab
  • Other: sham
Study Arms  ICMJE
  • 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. doi: 10.1007/s00417-010-1303-3. 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
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01025934
Other Study ID Numbers  ICMJE IVBDRNA
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE University of Campania "Luigi Vanvitelli"
Collaborators  ICMJE Napoli CTO Hospital
Investigators  ICMJE Not Provided
PRS Account University of Campania "Luigi Vanvitelli"
Verification Date December 2009

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