Comparison of Subconjuctival Versus Topical Bevacizumab as Adjunct Therapy to Trabeculectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01425112
Recruitment Status : Completed
First Posted : August 29, 2011
Last Update Posted : August 29, 2011
Information provided by (Responsible Party):
Aditya Sudhalkar, Sudhalkar Eye Hospital

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 Not Applicable

Study Type : Interventional  (Clinical Trial)
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 : December 2007
Actual Primary Completion Date : May 2011
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Bevacizumab
U.S. FDA Resources

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

Primary Outcome Measures :
  1. Intraocular pressure control [ Time Frame: For 2 years ]

Secondary Outcome Measures :
  1. Progression [ Time Frame: 2 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   42 Years and older   (Adult, Senior)
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

Responsible Party: Aditya Sudhalkar, Dr. Aditya Anand Sudhalkar, Sudhalkar Eye Hospital Identifier: NCT01425112     History of Changes
Other Study ID Numbers: 31234EH
First Posted: August 29, 2011    Key Record Dates
Last Update Posted: August 29, 2011
Last Verified: August 2011

Keywords provided by Aditya Sudhalkar, Sudhalkar Eye Hospital:

Additional relevant MeSH terms:
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents