Subconjunctival Bevacizumab Effect on Bleb Vascularity
Primary Purpose
Bleb Vascularity, Bleb Fibrosis, Trabeculectomy Failure
Status
Unknown status
Phase
Phase 2
Locations
Israel
Study Type
Interventional
Intervention
Bevacizumab
Sponsored by
About this trial
This is an interventional prevention trial for Bleb Vascularity focused on measuring bevacizumab, subconjunctival injection, trabeculectomy, bleb, mitomycin c
Eligibility 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
Sites / Locations
- Rabin Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
No Intervention
Arm Label
1
2
3
Arm Description
20 patients who had an uneventful trabeculectomy with usage of mitomycin C, will receive subconjunctival bevacizumab 1 week after the surgery
20 patients who had an uneventful trabeculectomy with usage of mitomycin C, will receive subconjunctival bevacizumab 2 weeks after the surgery
20 patients after an uneventful trabeculectomy with usage of mitomycin C, will not receive any bevacizumab injection.
Outcomes
Primary Outcome Measures
Bleb vascularity grading
Secondary Outcome Measures
Indiana Bleb Appearance Grading Scale (IBAGS)
Intra-ocular pressure
Indication for subconjunctival Mitomycin C injection or revision of surgery = yes / no
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00854529
Brief Title
Subconjunctival Bevacizumab Effect on Bleb Vascularity
Official Title
Subconjunctival Bevacizumab Injection for the Prevention of Bleb Vascularization Post Trabeculectomy
Study Type
Interventional
2. Study Status
Record Verification Date
February 2009
Overall Recruitment Status
Unknown status
Study Start Date
April 2009 (undefined)
Primary Completion Date
April 2011 (Anticipated)
Study Completion Date
October 2011 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Rabin Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bleb Vascularity, Bleb Fibrosis, Trabeculectomy Failure
Keywords
bevacizumab, subconjunctival injection, trabeculectomy, bleb, mitomycin c
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
20 patients who had an uneventful trabeculectomy with usage of mitomycin C, will receive subconjunctival bevacizumab 1 week after the surgery
Arm Title
2
Arm Type
Active Comparator
Arm Description
20 patients who had an uneventful trabeculectomy with usage of mitomycin C, will receive subconjunctival bevacizumab 2 weeks after the surgery
Arm Title
3
Arm Type
No Intervention
Arm Description
20 patients after an uneventful trabeculectomy with usage of mitomycin C, will not receive any bevacizumab injection.
Intervention Type
Drug
Intervention Name(s)
Bevacizumab
Other Intervention Name(s)
Avastin
Intervention Description
sub-conjunctival injection of 1.25mg Bevacizumab
Primary Outcome Measure Information:
Title
Bleb vascularity grading
Time Frame
1, 2, 3, 4, 5. 6. montes post operative.
Secondary Outcome Measure Information:
Title
Indiana Bleb Appearance Grading Scale (IBAGS)
Time Frame
1, 2, 3, 4, 5, 6 months post operative
Title
Intra-ocular pressure
Time Frame
1, 2, 3, 4, 5, 6 months post operative
Title
Indication for subconjunctival Mitomycin C injection or revision of surgery = yes / no
Time Frame
1, 2, 3, 4, 5, 6 months post operative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
moshe lusky, MD
Phone
972-39376113
Email
moshel@clalit.org.il
First Name & Middle Initial & Last Name or Official Title & Degree
omer Y bialer, MD
Phone
972-39376100
Email
omerb2@clalit.org.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
moshe lusky, MD
Organizational Affiliation
Rabin Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
omer Y bialer, MD
Organizational Affiliation
rabin medial center
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
anat robinson, MD
Organizational Affiliation
Rabin Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
Rabin Medical Center
City
Petah-tikva
ZIP/Postal Code
49100
Country
Israel
12. IPD Sharing Statement
Citations:
PubMed Identifier
18026201
Citation
Ichhpujani P, Ramasubramanian A, Kaushik S, Pandav SS. Bevacizumab in glaucoma: a review. Can J Ophthalmol. 2007 Dec;42(6):812-5. doi: 10.3129/i07-160.
Results Reference
background
PubMed Identifier
9932993
Citation
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. doi: 10.1016/s0002-9394(98)00290-6.
Results Reference
result
PubMed Identifier
18692246
Citation
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. doi: 10.1016/j.ophtha.2008.06.009. Epub 2008 Aug 9.
Results Reference
result
PubMed Identifier
18854726
Citation
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. doi: 10.1097/IJG.0b013e31815f5345.
Results Reference
result
PubMed Identifier
16583638
Citation
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.
Results Reference
result
Citation
Treatment of Failing Blebs with Ranibizumab. Study number NCT00570726. http://clinicaltrials.gov
Results Reference
result
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Subconjunctival Bevacizumab Effect on Bleb Vascularity
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