Subconjunctival Bevacizumab Injection for the Prevention of Bleb Vascularization Post Trabeculectomy
Trial Snapshot
- Phase
- Phase 2
- Sponsor
- Rabin Medical Center
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Bleb vascularity grading
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •post uneventful trabeculectomy with mitomycin c application during surgery
Exclusion Criteria
- •usage of 5-fluorouracil in trabeculectomy
- •post-operative complications
- •ischemic heart disease
- •s/p cerebrovascular accident
- •allergy to bevacizumab
Arms & Interventions
1
20 patients who had an uneventful trabeculectomy with usage of mitomycin C, will receive subconjunctival bevacizumab 1 week after the surgery
Intervention: Bevacizumab (Drug)
2
20 patients who had an uneventful trabeculectomy with usage of mitomycin C, will receive subconjunctival bevacizumab 2 weeks after the surgery
Intervention: Bevacizumab (Drug)
Outcomes
Primary Outcomes
Bleb vascularity grading
Time Frame: 1, 2, 3, 4, 5. 6. montes post operative.
Secondary Outcomes
- Indiana Bleb Appearance Grading Scale (IBAGS)(1, 2, 3, 4, 5, 6 months post operative)
- Intra-ocular pressure(1, 2, 3, 4, 5, 6 months post operative)
- Indication for subconjunctival Mitomycin C injection or revision of surgery = yes / no(1, 2, 3, 4, 5, 6 months post operative)