Comparison of Subconjuctival Versus Topical Bevacizumab as Adjunct Therapy to Trabeculectomy

NCT ID: NCT01425112

Last Updated: 2011-08-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-12-31
• Study Completion Date: 2011-06-30

Brief Summary

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.

Conditions

Complications of Treatment; Progression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Topical/Subconjunctival

Depending upon the mode of administration

Group Type: EXPERIMENTAL

Phacoemulsification

Intervention Type: PROCEDURE

Surgery for complications of trabeculectomy

Interventions

Phacoemulsification

Surgery for complications of trabeculectomy

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 42 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sudhalkar Eye Hospital

OTHER

Sponsor Role: lead

Responsible Party

Aditya Sudhalkar

Dr. Aditya Anand Sudhalkar

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

31234EH

Identifier Type: -

Identifier Source: org_study_id