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Effect of Intravitreal Bevacizumab on Early Post-Vitrectomy Hemorrhage in Diabetic Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2007 by Shahid Beheshti Medical University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Shahid Beheshti Medical University
ClinicalTrials.gov Identifier:
NCT00524875
First received: September 4, 2007
Last updated: NA
Last verified: August 2007
History: No changes posted

September 4, 2007
September 4, 2007
January 2007
Not Provided
early post-vitrectomy vitreous hemorrhage
Same as current
No Changes Posted
Visual improvement
Same as current
Not Provided
Not Provided
 
Effect of Intravitreal Bevacizumab on Early Post-Vitrectomy Hemorrhage in Diabetic Patients
Not Provided

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
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Diabetic Retinopathy
Drug: Bevacizumab
One dose of bevacizumab (1.25 mg/0.05 cc) one to two weeks before pars plana vitrectomy for diabetic retinopathy
  • Experimental: 1
    Intravitreal bevacizumab injection 1-2 weeks before surgery
    Intervention: Drug: Bevacizumab
  • Sham Comparator: 2
    Sham injection (needleless syringe pressed against conjunctiva)
    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.
 
Recruiting
80
September 2007
Not Provided

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
Not Provided
No
Contact: Hamid Ahmadieh, MD +98 21 22585952 hahmadieh@hotmail.com
Iran, Islamic Republic of
 
NCT00524875
8657
Yes
Not Provided
Shahid Beheshti Medical University
Not Provided
Principal Investigator: Hamid Ahmadieh, MD Ophthalmic Research Center of Shaheed Beheshti Medical University
Shahid Beheshti Medical University
August 2007

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