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Subconjunctival Bevacizumab Effect on Bleb Vascularity

Subconjunctival Bevacizumab Injection for the Prevention of Bleb Vascularization Post Trabeculectomy

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00854529
Enrollment
60
Registered
2009-03-03
Start date
2009-04-30
Completion date
2011-10-31
Last updated
2009-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bleb Fibrosis, Bleb Vascularity, Trabeculectomy Failure

Keywords

bevacizumab, subconjunctival injection, trabeculectomy, bleb, mitomycin c

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.

Interventions

DRUGBevacizumab

sub-conjunctival injection of 1.25mg Bevacizumab

Sponsors

Rabin Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* post uneventful trabeculectomy with mitomycin c application during surgery * adult

Exclusion criteria

* usage of 5-fluorouracil in trabeculectomy * post-operative complications * ischemic heart disease * s/p cerebrovascular accident * allergy to bevacizumab

Design outcomes

Primary

MeasureTime frame
Bleb vascularity grading1, 2, 3, 4, 5. 6. montes post operative.

Secondary

MeasureTime frame
Indiana Bleb Appearance Grading Scale (IBAGS)1, 2, 3, 4, 5, 6 months post operative
Intra-ocular pressure1, 2, 3, 4, 5, 6 months post operative
Indication for subconjunctival Mitomycin C injection or revision of surgery = yes / no1, 2, 3, 4, 5, 6 months post operative

Countries

Israel

Contacts

Primary Contactmoshe lusky, MD
moshel@clalit.org.il972-39376113
Backup Contactomer Y bialer, MD
omerb2@clalit.org.il972-39376100

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026