Comparison of Subconjuctival Versus Topical Bevacizumab as Adjunct Therapy to Trabeculectomy

Sudhalkar Eye Hospital

Status: Completed

Conditions: Complications of Treatment; Progression

Treatments: Procedure: Phacoemulsification

Study type: Interventional

Funder types: Other

Identifiers

NCT01425112

31234EH

Details and patient eligibility

About

Bevacizumab is an anti vascular endothelial growth factor(anti-VEGF) substance that is known to reduce neovascularization and fibrovascular proliferation in inflammatory conditions, including post-operative inflammation. It has shown efficacy in numerous ocular conditions(off-label), that includes Age related macular degeneration, proliferative diabetic retinopathy, neovascular glaucoma and corneal neovascularization. It is being explored as an option for preventing recurrence of pterygium and as an adjunct to improving outcomes of trabeculectomy. There is a debate as to the mode and duration of bevacizumab administration for trabeculectomy. This study aims to compare a single subconjunctival dose of bevacizumab with topical therapy over one month in terms of outcomes of trabeculectomy surgery, non-progression of field loss and stable intraocular pressure(IOP) control.

Enrollment: 180 patients

Sex: All

Ages: 42+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Primary Open Angle Glaucoma
• Progression
• Failure to reach target IOP
• Non compliant

Exclusion criteria

• Resurgery
• Systemic contraindication to bevacizumab
• All other forms of glaucoma

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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180 participants in 1 patient group

Topical/Subconjunctival

Experimental group

Description:

Depending upon the mode of administration

Treatment:

Procedure: Phacoemulsification