Comparison of Subconjuctival Versus Topical Bevacizumab as Adjunct Therapy to Trabeculectomy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Aditya Sudhalkar, Sudhalkar Eye Hospital
ClinicalTrials.gov Identifier:
NCT01425112
First received: August 25, 2011
Last updated: August 26, 2011
Last verified: August 2011
  Purpose

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 Intervention
Complications of Treatment
Progression
Procedure: Phacoemulsification

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Sudhalkar Eye Hospital:

Primary Outcome Measures:
  • Intraocular pressure control [ Time Frame: For 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment: 180
Study Start Date: December 2007
Study Completion Date: June 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Topical/Subconjunctival
Depending upon the mode of administration
Procedure: Phacoemulsification
Surgery for complications of trabeculectomy

  Eligibility

Ages Eligible for Study:   42 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Aditya Sudhalkar, Dr. Aditya Anand Sudhalkar, Sudhalkar Eye Hospital
ClinicalTrials.gov Identifier: NCT01425112     History of Changes
Other Study ID Numbers: 31234EH
Study First Received: August 25, 2011
Last Updated: August 26, 2011
Health Authority: India: Drugs Controller General of India

Keywords provided by Sudhalkar Eye Hospital:
trabeculectomy
bevacizumab
anti-VEGF
Efficacy

Additional relevant MeSH terms:
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 18, 2014