Subconjunctival Bevacizumab Effect on Bleb Vascularity

Clalit Health Services

Status and phase: Unknown; Phase 2

Conditions: Bleb Vascularity; Trabeculectomy Failure; Bleb Fibrosis

Treatments: Drug: Bevacizumab

Study type: Interventional

Funder types: Other

Identifiers

NCT00854529

005285

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 3 patient groups

1

Experimental group

Description:

20 patients who had an uneventful trabeculectomy with usage of mitomycin C, will receive subconjunctival bevacizumab 1 week after the surgery

Treatment:

Drug: Bevacizumab

2

Active Comparator group

Description:

20 patients who had an uneventful trabeculectomy with usage of mitomycin C, will receive subconjunctival bevacizumab 2 weeks after the surgery

Treatment:

Drug: Bevacizumab

3

No Intervention group

Description:

20 patients after an uneventful trabeculectomy with usage of mitomycin C, will not receive any bevacizumab injection.