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Comparison of Subconjuctival Versus Topical Bevacizumab as Adjunct Therapy to Trabeculectomy

Primary Purpose

Complications of Treatment, Progression

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Phacoemulsification
Sponsored by
Sudhalkar Eye Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Complications of Treatment focused on measuring trabeculectomy, bevacizumab, anti-VEGF, Efficacy

Eligibility Criteria

42 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Topical/Subconjunctival

    Arm Description

    Depending upon the mode of administration

    Outcomes

    Primary Outcome Measures

    Intraocular pressure control

    Secondary Outcome Measures

    Progression

    Full Information

    First Posted
    August 25, 2011
    Last Updated
    August 26, 2011
    Sponsor
    Sudhalkar Eye Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01425112
    Brief Title
    Comparison of Subconjuctival Versus Topical Bevacizumab as Adjunct Therapy to Trabeculectomy
    Official Title
    Clinical Trial Comparing Subconjunctival and Topical Bevacizumab as Adjuncts to Trabeculectomy in Improving Outcomes for Primary Open Angle Glaucoma
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2011
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2007 (undefined)
    Primary Completion Date
    May 2011 (Actual)
    Study Completion Date
    June 2011 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Sudhalkar Eye Hospital

    4. Oversight

    Data Monitoring Committee
    Yes

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Complications of Treatment, Progression
    Keywords
    trabeculectomy, bevacizumab, anti-VEGF, Efficacy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    180 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Topical/Subconjunctival
    Arm Type
    Experimental
    Arm Description
    Depending upon the mode of administration
    Intervention Type
    Procedure
    Intervention Name(s)
    Phacoemulsification
    Intervention Description
    Surgery for complications of trabeculectomy
    Primary Outcome Measure Information:
    Title
    Intraocular pressure control
    Time Frame
    For 2 years
    Secondary Outcome Measure Information:
    Title
    Progression
    Time Frame
    2 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    42 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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

    12. IPD Sharing Statement

    Learn more about this trial

    Comparison of Subconjuctival Versus Topical Bevacizumab as Adjunct Therapy to Trabeculectomy

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