Subconjunctival Bevacizumab Effect on Bleb Vascularity - Full Text View

Sponsor:	Rabin Medical Center
Information provided by:	Rabin Medical Center
ClinicalTrials.gov Identifier:	NCT00854529

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 II

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:

Drug Information available for: Mitomycin Bevacizumab Mitomycins

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:

Schwartz AL, Van Veldhuisen PC, Gaasterland DE, Ederer F, Sullivan EK, Cyrlin MN. The Advanced Glaucoma Intervention Study (AGIS): 5. Encapsulated bleb after initial trabeculectomy. Am J Ophthalmol. 1999 Jan;127(1):8-19.

Grewal DS, Jain R, Kumar H, Grewal SP. Evaluation of subconjunctival bevacizumab as an adjunct to trabeculectomy a pilot study. Ophthalmology. 2008 Dec;115(12):2141-2145.e2. Epub 2008 Aug 9.

Coote MA, Ruddle JB, Qin Q, Crowston JG. Vascular changes after intra-bleb injection of bevacizumab. J Glaucoma. 2008 Oct-Nov;17(7):517-8.

Kahook MY, Schuman JS, Noecker RJ. Needle bleb revision of encapsulated filtering bleb with bevacizumab. Ophthalmic Surg Lasers Imaging. 2006 Mar-Apr;37(2):148-50.

Ichhpujani P, Ramasubramanian A, Kaushik S, Pandav SS. Bevacizumab in glaucoma: a review. Can J Ophthalmol. 2007 Dec;42(6):812-5. Review.

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 February 09, 2012