Effect of Intravitreal Bevacizumab on Early Post-Vitrectomy Hemorrhage in Diabetic Patients
Information source: Shaheed Beheshti Medical University
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Diabetic Retinopathy
Intervention: Bevacizumab (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Shaheed Beheshti Medical University Official(s) and/or principal investigator(s):
Hamid Ahmadieh, MD, Principal Investigator, Affiliation: Ophthalmic Research Center of Shaheed Beheshti Medical University
Overall contact:
Hamid Ahmadieh, MD, Phone: +98 21 22585952, Email: hahmadieh@hotmail.com
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.
Clinical Details
Study design: Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: early post-vitrectomy vitreous hemorrhage
Secondary outcome: Visual improvement
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.
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Hamid Ahmadieh, MD, Phone: +98 21 22585952, Email: hahmadieh@hotmail.com
Hamid Ahmadieh, MD, Tehran 16666, Iran, Islamic Republic of; Recruiting
Hamid Ahmadieh, MD, Phone: +98 21 22585952, Email: hahmadieh@hotmail.com
Additional Information
Starting date: January 2007
Ending date: September 2007
Last updated: September 4, 2007
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