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

Tracking Information

First Received Date ^ICMJE

March 1, 2009

Last Updated Date

March 2, 2009

Start Date ^ICMJE

April 2009

Estimated Primary Completion Date

April 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00854529 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Subconjunctival Bevacizumab Effect on Bleb Vascularity

Official Title ^ICMJE

Subconjunctival Bevacizumab Injection for the Prevention of Bleb Vascularization Post Trabeculectomy

Brief Summary

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.

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 ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention

Condition ^ICMJE

Bleb Vascularity
Bleb Fibrosis
Trabeculectomy Failure

Intervention ^ICMJE

Drug: Bevacizumab

sub-conjunctival injection of 1.25mg Bevacizumab

Other Name: Avastin

Study Arm (s)

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.

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

October 2011

Estimated Primary Completion Date

April 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

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

Location Countries ^ICMJE

Israel

Administrative Information

NCT Number ^ICMJE

NCT00854529

Other Study ID Numbers ^ICMJE

005285

Has Data Monitoring Committee

Yes

Responsible Party

Moshe Lusky / MD, Rabin Medical Center

Study Sponsor ^ICMJE

Rabin Medical Center

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

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

Information Provided By

Rabin Medical Center

Verification Date

February 2009

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

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