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

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ClinicalTrials.gov Identifier: NCT00524875
Recruitment Status : Unknown
Verified August 2007 by Shahid Beheshti University of Medical Sciences.
Recruitment status was:  Recruiting
First Posted : September 5, 2007
Last Update Posted : September 5, 2007
Sponsor:
Information provided by:
Shahid Beheshti University of Medical Sciences

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Diabetic Retinopathy Drug: Bevacizumab Not Applicable

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Study Start Date : January 2007
Estimated Study Completion Date : September 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Bevacizumab
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
Intravitreal bevacizumab injection 1-2 weeks before surgery
Drug: Bevacizumab
One dose of bevacizumab (1.25 mg/0.05 cc) one to two weeks before pars plana vitrectomy for diabetic retinopathy
Sham Comparator: 2
Sham injection (needleless syringe pressed against conjunctiva)
Drug: Bevacizumab
One dose of bevacizumab (1.25 mg/0.05 cc) one to two weeks before pars plana vitrectomy for diabetic retinopathy



Primary Outcome Measures :
  1. early post-vitrectomy vitreous hemorrhage

Secondary Outcome Measures :
  1. Visual improvement


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00524875


Contacts
Contact: Hamid Ahmadieh, MD +98 21 22585952 hahmadieh@hotmail.com

Locations
Iran, Islamic Republic of
Hamid Ahmadieh, MD Recruiting
Tehran, Iran, Islamic Republic of, 16666
Contact: Hamid Ahmadieh, MD    +98 21 22585952    hahmadieh@hotmail.com   
Sponsors and Collaborators
Shahid Beheshti University of Medical Sciences
Investigators
Principal Investigator: Hamid Ahmadieh, MD Ophthalmic Research Center of Shaheed Beheshti Medical University

ClinicalTrials.gov Identifier: NCT00524875     History of Changes
Other Study ID Numbers: 8657
First Posted: September 5, 2007    Key Record Dates
Last Update Posted: September 5, 2007
Last Verified: August 2007

Keywords provided by Shahid Beheshti University of Medical Sciences:
Proliferative diabetic retinopathy
Bevacizumab
Early post-vitrectomy vitreous hemorrhage

Additional relevant MeSH terms:
Retinal Diseases
Diabetic Retinopathy
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents