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Effect of Intravitreal Bevacizumab on Early Post-Vitrectomy Hemorrhage in Diabetic Patients
This study is currently recruiting participants.
Study NCT00524875   Information provided by Shaheed Beheshti Medical University
First Received: September 4, 2007   No Changes Posted

September 4, 2007
September 4, 2007
January 2007
 
early post-vitrectomy vitreous hemorrhage
Same as current
No Changes Posted
Visual improvement
Same as current
 
Effect of Intravitreal Bevacizumab on Early Post-Vitrectomy Hemorrhage in Diabetic Patients
 

The purpose of this study is to determine whether bevacizumab 1-2 weeks before vitrectomy is effective in lowering the rate of early post-vitrectomy vitreous hemorrhage in diabetic patients.

Diabetes is the leading cause of blindness in the age range of 20-64 years. Pars plana vitrectomy may be indicated for the management of advanced proliferative diabetic retinopathy. Early post-vitrectomy hemorrhage in diabetic patients is relatively common; it occurs in 29% -75% of patients in the first month after surgery. This may cause delayed visual rehabilitation and detection of surgical complications such as retinal break or detachment. Preliminary reports such as case series reported by Spaide RF, et al showed beneficial effect of bevacizumab in proliferative diabetic retinopathy complicated by vitreous hemorrhage.

 
Interventional
Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Diabetic Retinopathy
Drug: Bevacizumab
  • Experimental: Intravitreal bevacizumab injection 1-2 weeks before surgery
  • Sham Comparator: Sham injection (needleless syringe pressed against conjunctiva)
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
80
September 2007
 

Inclusion Criteria:

  • All eyes who are candidate for pars plana vitrectomy because of complications of diabetic retinopathy such as nonclearing vitreous hemorrhage, tractional retinal detachment threatening macula, active progressive PDR

Exclusion Criteria:

  • One eye patient
  • Best corrected visual acuity better than 20/50
  • Pregnancy
  • Use of internal tamponade such as silicone oil during surgery
  • Concurrent ophthalmic surgery such as cataract extraction
Both
 
No
Contact: Hamid Ahmadieh, MD +98 21 22585952 hahmadieh@hotmail.com
Iran, Islamic Republic of
 
NCT00524875
 
8657
Shaheed Beheshti Medical University
 
Principal Investigator: Hamid Ahmadieh, MD Ophthalmic Research Center of Shaheed Beheshti Medical University
Shaheed Beheshti Medical University
August 2007

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