Subconjunctival Bevacizumab Effect on Bleb Vascularity

Sponsor
Rabin Medical Center
Study ID
NCT00854529
Phase
PHASE2
Status
Unknown

Conditions

  • Bleb Fibrosis
  • Bleb Vascularity
  • Trabeculectomy Failure

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Bevacizumab — DRUG
    sub-conjunctival injection of 1.25mg Bevacizumab

Study Details

Trabeculectomy is an ocular surgery intended to reduce intra-ocular pressure the surgery creates a sub-conjunctival filtering bleb which filters aqueous humor fluid out. A rather common adverse event of the surgery is increasing vascularity of the conjunctiva overlying the bleb. This leads to adherence of the conjunctiva to the sclera and fibrosis and finally failure of the bleb (and of the surgery) this study intends to demonstrate that post operative subconjunctival bevacizumab injection will reduce incidence of bleb vascularity and ultimately, bleb failure.

Key Dates

First listed
Mar 3, 2009
Start date
Apr 30, 2009
Status verified
Feb 2009
Primary completion
Apr 30, 2011
Completion
Oct 31, 2011

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: 1
    20 patients who had an uneventful trabeculectomy with usage of mitomycin C, will receive subconjunctival bevacizumab 1 week after the surgery
  • Active Comparator: 2
    20 patients who had an uneventful trabeculectomy with usage of mitomycin C, will receive subconjunctival bevacizumab 2 weeks after the surgery
  • No Intervention: 3
    20 patients after an uneventful trabeculectomy with usage of mitomycin C, will not receive any bevacizumab injection.

Primary Outcome Measure

Bleb vascularity grading [ Time Frame: 1, 2, 3, 4, 5. 6. montes post operative. ]

Central Contacts