Comparison of Subconjuctival Versus Topical Bevacizumab as Adjunct Therapy to Trabeculectomy

Progression Clinical Trial

Official title:

Clinical Trial Comparing Subconjunctival and Topical Bevacizumab as Adjuncts to Trabeculectomy in Improving Outcomes for Primary Open Angle Glaucoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01425112
• Other study ID #: 31234EH
• Status: Completed
• Phase: N/A
• First received: August 25, 2011
• Last updated: August 26, 2011
• Start date: December 2007
• Est. completion date: June 2011

Study information

• Verified date: August 2011
• Source: Sudhalkar Eye Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Drugs Controller General of India
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: June 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 42 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Complications of Treatment
• Progression

Intervention

Procedure:
• Phacoemulsification
Surgery for complications of trabeculectomy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sudhalkar Eye Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraocular pressure control		For 2 years	No
Secondary	Progression		2 years	No