Subconjunctival Bevacizumab Effect on Bleb Vascularity

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by Rabin Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Rabin Medical Center
ClinicalTrials.gov Identifier:
NCT00854529
First received: March 1, 2009
Last updated: March 2, 2009
Last verified: February 2009

March 1, 2009
March 2, 2009
April 2009
April 2011   (final data collection date for primary outcome measure)
Bleb vascularity grading [ Time Frame: 1, 2, 3, 4, 5. 6. montes post operative. ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00854529 on ClinicalTrials.gov Archive Site
  • Indiana Bleb Appearance Grading Scale (IBAGS) [ Time Frame: 1, 2, 3, 4, 5, 6 months post operative ] [ Designated as safety issue: No ]
  • Intra-ocular pressure [ Time Frame: 1, 2, 3, 4, 5, 6 months post operative ] [ Designated as safety issue: No ]
  • Indication for subconjunctival Mitomycin C injection or revision of surgery = yes / no [ Time Frame: 1, 2, 3, 4, 5, 6 months post operative ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Subconjunctival Bevacizumab Effect on Bleb Vascularity
Subconjunctival Bevacizumab Injection for the Prevention of Bleb Vascularization Post Trabeculectomy

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.

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 wishes to demonstrate that post operative subconjunctival bevacizumab injection will reduce incidence of bleb vascularity and ultimately, bleb failure.

during the study, one study group will be given subconjunctival bevacizumab 1 week after surgery, another study group will be given subconjunctival bevacizumab 2 week after surgery, and a third group will serve as control and will not receive bevacizumab. if bleb vascularity will be diagnosed all patients will be treated according to current guidelines.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Bleb Vascularity
  • Bleb Fibrosis
  • Trabeculectomy Failure
Drug: Bevacizumab
sub-conjunctival injection of 1.25mg Bevacizumab
Other Name: Avastin
  • Experimental: 1
    20 patients who had an uneventful trabeculectomy with usage of mitomycin C, will receive subconjunctival bevacizumab 1 week after the surgery
    Intervention: Drug: Bevacizumab
  • Active Comparator: 2
    20 patients who had an uneventful trabeculectomy with usage of mitomycin C, will receive subconjunctival bevacizumab 2 weeks after the surgery
    Intervention: Drug: Bevacizumab
  • No Intervention: 3
    20 patients after an uneventful trabeculectomy with usage of mitomycin C, will not receive any bevacizumab injection.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
60
October 2011
April 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • post uneventful trabeculectomy with mitomycin c application during surgery
  • adult

Exclusion Criteria:

  • usage of 5-fluorouracil in trabeculectomy
  • post-operative complications
  • ischemic heart disease
  • s/p cerebrovascular accident
  • allergy to bevacizumab
Both
18 Years and older
No
Contact: moshe lusky, MD 972-39376113 moshel@clalit.org.il
Contact: omer Y bialer, MD 972-39376100 omerb2@clalit.org.il
Israel
 
NCT00854529
005285
Yes
Moshe Lusky / MD, Rabin Medical Center
Rabin Medical Center
Not Provided
Principal Investigator: moshe lusky, MD Rabin Medical Center
Study Chair: omer Y bialer, MD rabin medial center
Study Chair: anat robinson, MD Rabin Medical Center
Rabin Medical Center
February 2009

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