Subconjunctival Bevacizumab Effect on Bleb Vascularity

March 2, 2009 updated by: Rabin Medical Center

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Israel
      • Petah-tikva, Israel, 49100
        • Rabin Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • Avastin
NO_INTERVENTION: 3
20 patients after an uneventful trabeculectomy with usage of mitomycin C, will not receive any bevacizumab injection.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Indiana Bleb Appearance Grading Scale (IBAGS)
Time Frame: 1, 2, 3, 4, 5, 6 months post operative
1, 2, 3, 4, 5, 6 months post operative
Intra-ocular pressure
Time Frame: 1, 2, 3, 4, 5, 6 months post operative
1, 2, 3, 4, 5, 6 months post operative
Indication for subconjunctival Mitomycin C injection or revision of surgery = yes / no
Time Frame: 1, 2, 3, 4, 5, 6 months post operative
1, 2, 3, 4, 5, 6 months post operative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (ANTICIPATED)

April 1, 2011

Study Completion (ANTICIPATED)

October 1, 2011

Study Registration Dates

First Submitted

March 1, 2009

First Submitted That Met QC Criteria

March 2, 2009

First Posted (ESTIMATE)

March 3, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

March 3, 2009

Last Update Submitted That Met QC Criteria

March 2, 2009

Last Verified

February 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 005285

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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