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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

August 25, 2011
August 26, 2011
December 2007
May 2011   (final data collection date for primary outcome measure)
Intraocular pressure control [ Time Frame: For 2 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01425112 on ClinicalTrials.gov Archive Site
Progression [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Comparison of Subconjuctival Versus Topical Bevacizumab as Adjunct Therapy to Trabeculectomy
Clinical Trial Comparing Subconjunctival and Topical Bevacizumab as Adjuncts to Trabeculectomy in Improving Outcomes for Primary Open Angle Glaucoma

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Complications of Treatment
  • Progression
Procedure: Phacoemulsification
Surgery for complications of trabeculectomy
Experimental: Topical/Subconjunctival
Depending upon the mode of administration
Intervention: Procedure: Phacoemulsification
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
180
June 2011
May 2011   (final data collection date for primary outcome measure)

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
Both
42 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01425112
31234EH
Yes
Aditya Sudhalkar, Sudhalkar Eye Hospital
Sudhalkar Eye Hospital
Not Provided
Not Provided
Sudhalkar Eye Hospital
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP