A Phase 2 interventional study of Bevacizumab in Bleb Vascularity, Bleb Fibrosis and Trabeculectomy Failure, sponsored by Rabin Medical Center. Status unknown at 1 site in Israel. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2009-03-03.
Sponsored by Rabin Medical Center · Phase 2, Interventional, and Prevention
Trabeculectomy is an ocular surgery intended to reduce intra-ocular pressure the surgery creates a sub-conjunctival filtering bleb which filters aqueous humor fluid out.
A rather common adverse event of the surgery is increasing vascularity of the conjunctiva overlying the bleb. This leads to adherence of the conjunctiva to the sclera and fibrosis and finally failure of the bleb (and of the surgery) this study intends to demonstrate that post operative subconjunctival bevacizumab injection will reduce incidence of bleb vascularity and ultimately, bleb failure.
trabeculectomy is an ocular surgery intended to reduce intra-ocular pressure the surgery creates a sub-conjunctival filtering bleb which filters aqueous humor fluid out.
a rather common adverse event of the surgery is increasing vascularity of the conjunctiva overlying the bleb. this leads to adherence of the conjunctiva to the sclera and fibrosis and finally failure of the bleb (and of the surgery) this study wishes to demonstrate that post operative subconjunctival bevacizumab injection will reduce incidence of bleb vascularity and ultimately, bleb failure.
during the study, one study group will be given subconjunctival bevacizumab 1 week after surgery, another study group will be given subconjunctival bevacizumab 2 week after surgery, and a third group will serve as control and will not receive bevacizumab. if bleb vascularity will be diagnosed all patients will be treated according to current guidelines.
36 studies on the registry are indexed under Blister; 3 are open to participants now.
This study's planned enrollment of 60 is close to the median of 65 across 24 interventional studies indexed under Blister.
Browse Blister studies →Rabin Medical Center is the lead sponsor of 393 studies on the registry; 30 are open to participants now.
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Exclusion Criteria:
20 patients who had an uneventful trabeculectomy with usage of mitomycin C, will receive subconjunctival bevacizumab 1 week after the surgery
Drug: Bevacizumab
20 patients who had an uneventful trabeculectomy with usage of mitomycin C, will receive subconjunctival bevacizumab 2 weeks after the surgery
Drug: Bevacizumab
20 patients after an uneventful trabeculectomy with usage of mitomycin C, will not receive any bevacizumab injection.
sub-conjunctival injection of 1.25mg Bevacizumab
Also known as: Avastin
Bleb vascularity grading
Time frame: 1, 2, 3, 4, 5. 6. montes post operative.
Indiana Bleb Appearance Grading Scale (IBAGS)
Time frame: 1, 2, 3, 4, 5, 6 months post operative
Intra-ocular pressure
Time frame: 1, 2, 3, 4, 5, 6 months post operative
Indication for subconjunctival Mitomycin C injection or revision of surgery = yes / no
Time frame: 1, 2, 3, 4, 5, 6 months post operative
This study is status unknown, as verified in Feb 2009. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Bevacizumab