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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
History of Changes
  Purpose

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.


Condition Intervention Phase
Bleb Vascularity
Bleb Fibrosis
Trabeculectomy Failure
 Drug: Bevacizumab
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Subconjunctival Bevacizumab Injection for the Prevention of Bleb Vascularization Post Trabeculectomy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Rabin Medical Center:

Primary Outcome Measures:
  • Bleb vascularity grading [ Time Frame: 1, 2, 3, 4, 5. 6. montes post operative. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 60
Study Start Date: April 2009
Estimated Study Completion Date: October 2011
Estimated Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
20 patients who had an uneventful trabeculectomy with usage of mitomycin C, will receive subconjunctival bevacizumab 1 week after the surgery
 Drug: Bevacizumab
sub-conjunctival injection of 1.25mg Bevacizumab
Other Name: Avastin
Active Comparator: 2
20 patients who had an uneventful trabeculectomy with usage of mitomycin C, will receive subconjunctival bevacizumab 2 weeks after the surgery
 Drug: Bevacizumab
sub-conjunctival injection of 1.25mg Bevacizumab
Other Name: Avastin
No Intervention: 3
20 patients after an uneventful trabeculectomy with usage of mitomycin C, will not receive any bevacizumab injection.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00854529

Contacts
Contact: moshe lusky, MD 972-39376113 moshel@clalit.org.il
Contact: omer Y bialer, MD 972-39376100 omerb2@clalit.org.il

Locations
Israel
Rabin Medical Center
Petah-tikva, Israel, 49100
Sponsors and Collaborators
Rabin Medical Center
Investigators
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
  More Information

Publications:

Responsible Party: Moshe Lusky / MD, Rabin Medical Center
ClinicalTrials.gov Identifier: NCT00854529     History of Changes
Other Study ID Numbers: 005285
Study First Received: March 1, 2009
Last Updated: March 2, 2009
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Rabin Medical Center:
bevacizumab
subconjunctival injection
trabeculectomy
bleb
mitomycin c

Additional relevant MeSH terms:
Blister
Fibrosis
Skin Diseases, Vesiculobullous
Skin Diseases
Pathological Conditions, Anatomical
Pathologic Processes
Mitomycin
Bevacizumab
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
 Pharmacologic Actions
Alkylating Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on May 19, 2013