Subconjunctival Bevacizumab Effect on Bleb Vascularity

Phase 2

• Conditions: Bleb Vascularity; Bleb Fibrosis; Trabeculectomy Failure
• Interventions: Drug: Bevacizumab

• Registration Number: NCT00854529
• Lead Sponsor: Rabin Medical Center

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 Timeline

• Status Verified: 2009-02
• Study First Submitted: 2009-03-01
• Study First Submitted QC: 2009-03-02
• Last Update Submitted: 2009-03-02
• Study First Posted: 2009-03-03
• Last Update Posted: 2009-03-03
• Study Start: 2009-04
• Primary Completion: 2011-04
• Study Completion: 2011-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Bevacizumab	20 patients who had an uneventful trabeculectomy with usage of mitomycin C, will receive subconjunctival bevacizumab 2 weeks after the surgery
1	Bevacizumab	20 patients who had an uneventful trabeculectomy with usage of mitomycin C, will receive subconjunctival bevacizumab 1 week after the surgery

Primary Outcome Measures

Name	Time	Method
Bleb vascularity grading	1, 2, 3, 4, 5. 6. montes post operative.

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Rabin Medical Center; 🇮🇱 Petah-tikva, Israel