Comparison of Subconjuctival Versus Topical Bevacizumab as Adjunct Therapy to Trabeculectomy

• Sponsor: Sudhalkar Eye Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT01425112
• Collaborator: (none)
• Enrollment: 180
• Arm: 1
• Duration (Months): 42

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Complications of Treatment; Progression	Procedure: Phacoemulsification	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 180 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Clinical Trial Comparing Subconjunctival and Topical Bevacizumab as Adjuncts to Trabeculectomy in Improving Outcomes for Primary Open Angle Glaucoma
• Study Start Date: Dec 1, 2007
• Actual Primary Completion Date: May 1, 2011
• Actual Study Completion Date: Jun 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Topical/Subconjunctival Depending upon the mode of administration	Procedure: Phacoemulsification; Surgery for complications of trabeculectomy

Outcome Measures

Primary Outcome Measures

1. Intraocular pressure control [For 2 years]

Secondary Outcome Measures

1. Progression [2 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 42 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Sudhalkar Eye Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Aditya Sudhalkar, Dr. Aditya Anand Sudhalkar, Sudhalkar Eye Hospital
• ClinicalTrials.gov Identifier: NCT01425112
• Other Study ID Numbers: 31234EH
• First Posted: Aug 29, 2011
• Last Update Posted: Aug 29, 2011
• Last Verified: Aug 1, 2011

• Keywords provided by Aditya Sudhalkar, Dr. Aditya Anand Sudhalkar, Sudhalkar Eye Hospital: trabeculectomy; bevacizumab; anti-VEGF; Efficacy
• Additional relevant MeSH terms: Disease Progression

Study Results

No Results Posted as of Aug 29, 2011